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SWOG<br />

FALL <strong>2012</strong> GROUP MEETING<br />

© C.E. Andersen<br />

OCTOBER 17-20, <strong>2012</strong><br />

CHICAGO, ILLINOIS


2 <strong>Fall</strong> <strong>2012</strong><br />

Welcome to SWOG’s <strong>Fall</strong> <strong>2012</strong> <strong>Meeting</strong>!<br />

There sure seems to be lots going on – from national political campaigns, to new<br />

guidelines governing the cooperative groups and forming a new NCI network, to<br />

the transition of SWOG’s leadership. While all of that’s important, nothing is more<br />

important than continuing the work of the group, much of which gets accomplished<br />

at meetings such as this one.<br />

If you’ve got a smart phone, download our mobile guidebook and use it to schedule<br />

your time at the meeting. If you’re a regular Twitter user, use our #SWOG<strong>2012</strong>fa<br />

hash tag when you tweet from the meeting so your fellow members can stay<br />

informed.<br />

Here’s to a productive and educational Chicago meeting!<br />

Warmly,<br />

Laurence H. Baker, D.O.<br />

<strong>Group</strong> Chairman<br />

SWOG • Leading Cancer Research. Together.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 3<br />

Integrating clinical research with care and medical practice<br />

Annetine C. Gelijns, Ph.D.<br />

Chair,<br />

Department of Health Evidence and Policy,<br />

Mount Sinai School of Medicine<br />

Value-based insurance design<br />

A. Mark Fendrick, M.D.<br />

Co-Director,<br />

Center for Value-Based Insurance Design,<br />

University of Michigan<br />

Placebos as treatment for metastatic cancer in clinical trials<br />

Lowell E. Schnipper, M.D.<br />

Clinical Director and<br />

Chief of Hematology/Oncology,<br />

Beth Israel Deaconess Medical Center<br />

Discussant<br />

Rick Bangs, M.B.A.<br />

Chair,<br />

SWOG Patient Advocate Committee<br />

Does health care reform open new possibilities for better integrating clinical research<br />

with patient care and medical practice For a more rational balance of costs and care<br />

through value-based insurance reimbursement For more ethical approaches to incorporating<br />

placebos into clinical trials And once the doctors speak to these questions,<br />

what are patients to make of their answers<br />

Experts from a variety of disciplines and backgrounds will address these issues at the <strong>Fall</strong><br />

<strong>2012</strong> SWOG <strong>Group</strong> <strong>Meeting</strong> plenary session, with a patient advocate as rapporteur for<br />

the event.<br />

Health Care Reform and Clinical Trials<br />

A plenary session - SWOG <strong>Fall</strong> <strong>2012</strong> <strong>Group</strong> <strong>Meeting</strong><br />

12:15 – 2:45 pm<br />

Friday, October 19<br />

Regency B – D<br />

Hyatt Regency Chicago<br />

SWOG • Leading Cancer Research. Together.


4 <strong>Fall</strong> <strong>2012</strong><br />

GROUP MEETING INDEX<br />

.PAGE(S)<br />

Plenary Session.................................................................................................................................................................... 3 & 15<br />

Hyatt Regency Chicago Travel and Hotel Information and Hotel Maps.................................................................................. 7-8<br />

Schedule of Events.................................................................................................................................................................13-16<br />

Roster of Committee Speakers..............................................................................................................................................17-18<br />

Administrative Committees......................................................................................................................................................... 19<br />

The Hope Foundation................................................................................................................................................................... 20<br />

Accrual Information (Accrual by Institution and Accrual by Institution and Committee)..................................................23-30<br />

Committee Information<br />

Barlogie-Salmon Myeloma Committee...................................................................................................................15 & 31-34<br />

Board of Governors............................................................................................................................................................. 16<br />

Bone Marrow & Stem Cell Transplantation Committee........................................................................................................ 15<br />

Breast Committee.................................................................................................................................................15 & 35-42<br />

Cancer Control and Prevention Committees......................................................................................................14-15 & 43-64<br />

Cancer Survivorship Committee.................................................................................................................. 15 & 43-46<br />

Molecular Epidemiology Committee.................................................................................................................. 14 & 47<br />

Outcomes and Comparative Effectiveness Committee...................................................................................... 14 & 48<br />

Prevention Committee................................................................................................................................. 14 & 49-50<br />

Symptom Control and Quality of Life Committee.........................................................................................14 & 51-52<br />

Clinical Practices Committee............................................................................................................................................... 16<br />

Early Therapeutics Committee.................................................................................................................................... 14 & 65<br />

Gastrointestinal Committee...................................................................................................................................15 & 66-70<br />

Genitourinary Committee......................................................................................................................................16 & 71-74<br />

Gynecologic Committee....................................................................................................................................................... 75<br />

Leukemia Committee.............................................................................................................................................15 & 76-80<br />

Lung Committee....................................................................................................................................................16 & 81-85<br />

Lymphoma Committee...........................................................................................................................................16 & 86-89<br />

Melanoma Committee...........................................................................................................................................15 & 90-93<br />

Pharmaceutical Sciences Committee................................................................................................................................... 16<br />

Radiation Therapy Committee............................................................................................................................................. 16<br />

Surgery Committee.................................................................................................................................................... 15 & 22<br />

Training & Workshops<br />

CRA Clinical Trials Training Course..................................................................................................................................... 13<br />

Clinical Research Associates Continuing Education Workshop.................................................................................... 15 & 22<br />

Clinical Research Associates Open Forum................................................................................................................... 14 & 21<br />

Jeri and Noboru Oishi Symposium.............................................................................................................................. 13 & 21<br />

Special Symposia................................................................................................................................................... 5, 21 & 22<br />

Future <strong>Group</strong> <strong>Meeting</strong> Dates....................................................................................................................................................... 94<br />

<strong>Group</strong> <strong>Meeting</strong> Supporters................................................................................................................................................... 9 & 96<br />

SWOG • Leading Cancer Research. Together.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 5<br />

SWOG<br />

<strong>Fall</strong>Ê<strong>2012</strong>Ê<br />

<strong>Group</strong>Ê<strong>Meeting</strong><br />

Special<br />

Symposium:<br />

TheÊUseÊofÊ<br />

JamesÊHicks,ÊPh.D.<br />

SWOGÊInvestigator<br />

ProfessorÊofÊCancerÊGenomics<br />

ColdÊSpringÊHarborÊLaboratory<br />

SessionÊchair<br />

DanielÊF.ÊHayes,ÊM.D.<br />

StuartÊB.ÊPadnosÊProfessorÊofÊBreastÊCancerÊResarch<br />

ClinicalÊDirector,ÊBreastÊOncologyÊProgram<br />

UniversityÊofÊMichigan<br />

CTCs:ÊCurrentÊtechnologyÊandÊfutureÊapplications<br />

HowardÊI.ÊScher,ÊM.D.<br />

ChiefÊofÊGenitourinaryÊOncologyÊand<br />

D.ÊWayneÊCallowayÊChairÊinÊUrologicÊOncology<br />

SidneyÊKimmelÊCenterÊforÊUrologicÊandÊProstateÊCancers<br />

MemorialÊSloan-KetteringÊCancerÊCenter<br />

CirculatingÊtumorÊcellsÊasÊaÊreflectionÊofÊ<br />

Ê prostateÊcancerÊdiseaseÊbiology<br />

StefanieÊS.ÊJeffrey,ÊM.D.<br />

ChiefÊofÊSurgicalÊOncologyÊand<br />

ProfessorÊofÊSurgery<br />

StanfordÊUniversity<br />

TumorÊheterogeneityÊandÊsingleÊcellÊprofiling<br />

CirculatingÊTumorÊCellsÊ<br />

inÊCancerÊResearch<br />

Thursday,<br />

OctoberÊ18th<br />

1:00ÊÐÊ2:45Êpm<br />

RegencyÊAÊÐÊB<br />

AllÊSWOGÊmembersÊareÊinvited.<br />

SupportedÊbyÊTheÊHopeÊFoundation<br />

SWOG • Leading Cancer Research. Together.


6 <strong>Fall</strong> <strong>2012</strong><br />

Go Mobile at the <strong>Meeting</strong>!<br />

To manage your <strong>Group</strong> <strong>Meeting</strong> experience from your<br />

smartphone, download our mobile guidebook.<br />

You’ll be able to plan your day with a personalized<br />

schedule and browse exhibitors, maps and general show<br />

info, all in the palm of your hand.<br />

The guidebook app is compatible with iPhones, iPads,<br />

Android, and Blackberry devices.<br />

To get the app, use your phone’s QR-code reader to scan<br />

the code at right. Or choose one of these methods:<br />

1. <strong>Download</strong> 'Guidebook' from the Apple App Store or the Android Marketplace OR<br />

2. Go to m.guidebookapp.com from your Blackberry OR<br />

3. Visit guidebookapp.com/getit from your phone's browser.<br />

Once you’ve installed the Guidebook app, search for the SWOG <strong>Fall</strong> <strong>2012</strong> <strong>Group</strong> <strong>Meeting</strong><br />

Guide in the "download guides" section of the app.<br />

Tweeting the <strong>Meeting</strong><br />

Tag your <strong>Group</strong> <strong>Meeting</strong> tweets<br />

with<br />

#SWOG<strong>2012</strong>fa<br />

We’ll post the live stream of tagged <strong>Group</strong> <strong>Meeting</strong><br />

updates to the SWOG website, for ease of following by<br />

those who couldn’t make it.<br />

Follow SWOG at twitter.com/SWOG. Our username is @SWOG.<br />

SWOG • Leading Cancer Research. Together.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 7<br />

Hyatt Regency Chicago<br />

151 East Wacker Drive<br />

Chicago, Illinois 60601<br />

Phone: 312-565-1234<br />

Fax: 312-239-4414<br />

Chicago Travel & Hotel Information<br />

Arrival/Departure:<br />

Check-in time is 3:00 p.m. Check-out time is 12:00 noon.<br />

Room amenities include a full bath, hair dryer, ironing<br />

board and iron. The concierge staff serves as a liaison between<br />

guests and the hotel and outside services.<br />

Hotel Safety Deposit Boxes:<br />

For your convenience, safety deposit boxes are available<br />

at the front desk for your valuables. Please do not leave<br />

valuables in your room.<br />

Recreational Facilities:<br />

The fitness center offers a variety of exercise equipment,<br />

free weights, treadmills, and more, exclusively for hotel<br />

guests. It is open 24 hours a day.<br />

Hotel Restaurants and Lounges:<br />

• Stetson’s Chop House and Bar provide guests with an<br />

elegant atmosphere specializing in steaks and seafood.<br />

• The Bistro at 151 specializes in a variety of American<br />

and Mediterranean cuisine and offers guests a relaxing<br />

atmosphere to enjoy breakfast and lunch.<br />

• DaddyO’s Pub and Piano Bar features snacks and<br />

cocktails.<br />

• J’s Express offers breakfast, lunch or dinner for a<br />

quick meal.<br />

• The BIG Bar features the longest free-standing bar<br />

in North America and specializes in a wide variety of<br />

cocktails, wines, champagnes and cognacs.<br />

• In-room dining is available from 6:00 a.m. - 12:00 a.m.<br />

daily.<br />

Business Center:<br />

The Business Center is located on the Purple level in the<br />

East Tower of the hotel. It is open 24 hours a day, 7 days<br />

a week. The Business Center offers fax machines, computer<br />

services, color copies, mail drop, Internet access<br />

and photocopying.<br />

Ground Transportation:<br />

• A taxi ride from O’Hare airport to the hotel is approximately<br />

$35.00 one-way.<br />

• A taxi ride from Midway airport to the hotel is approximately<br />

$30.00 one-way.<br />

• Valet parking at the hotel is $52.00 per day for hotel<br />

guests.<br />

Temperature:<br />

The average high for October is 64 degrees and the average<br />

low is 46 degrees.<br />

Area Attractions:<br />

• Adler Planetarium and Astronomy Museum<br />

• Architectural Boat Tours<br />

• Art Institute of Chicago<br />

• Brookfield Zoo<br />

• Chicago ArchiCenter<br />

• Chicago Architecture Foundation<br />

• Chicago Botanic Garden<br />

• Chicago Cultural Center<br />

• Field Museum of National History<br />

• Frank Lloyd Wright Home and Studio<br />

• John G. Shedd Aquarium<br />

• John Hancock Center Observatory<br />

• Millennium Park<br />

• Museum of Contemporary Art<br />

• Museum of Science and Industry<br />

• Rockefeller Memorial Chapel<br />

• Sears Tower Skydeck<br />

Local Restaurants:<br />

(The hotel concierge can assist with reservations and suggestions)<br />

• Alinea - Eclectic<br />

• Atwood Cafe - American<br />

• Billy Goat Tavern - Burgers<br />

• Bistro 110 - Continental<br />

• Cape Cod Room - Seafood<br />

• Charlie Trotters - Eclectic<br />

• Heaven on Seven - American Regional<br />

• Mia Francesca - Italian<br />

• Mon Ami Gabi - French<br />

• Shaw’s Crab House and Blue Crab Lounge - Seafood<br />

• Silver Cloud - American<br />

• Spiaggia - Italian<br />

SWOG • Leading Cancer Research. Together.


8 <strong>Fall</strong> <strong>2012</strong><br />

HYATT REGENCY CHICAGO<br />

<strong>Meeting</strong> Rooms/Hotel Services<br />

31<br />

Acapulco, West Tower, Gold Level<br />

8<br />

2<br />

4<br />

6<br />

1<br />

3<br />

5<br />

7<br />

9<br />

Business Center<br />

and Package Pick-Up<br />

located on the Purple<br />

Level of the East Tower<br />

(one level below the<br />

Gold Level)<br />

7 Addams, West Tower, Silver Level<br />

36 Atlanta, West Tower, Gold Level<br />

20 Buckingham, West Tower, Bronze Level<br />

2 Burnham, West Tower, Silver Level<br />

24 Columbian, West Tower, Bronze Level<br />

37 Columbus A-F, East Tower, Gold Level<br />

SILVER LEVEL<br />

38 Columbus G-L, East Tower, Gold Level<br />

27<br />

Comiskey, West Tower, Bronze Level<br />

10<br />

14<br />

16<br />

Concierge, East Tower, Blue Level<br />

Crystal Ballrooms A-C, West Tower, Green Level<br />

11<br />

12<br />

13<br />

15<br />

14<br />

8<br />

6<br />

29<br />

DuSable, West Tower, Silver Level<br />

Field, West Tower, Silver Level<br />

Fitness Center, East Tower, Bronze Level<br />

13<br />

Front Desk, East Tower, Blue Level<br />

BLUE LEVEL<br />

21<br />

22<br />

32<br />

Gold Coast, West Tower, Bronze Level<br />

Haymarket, West Tower, Bronze Level<br />

Hong Kong, West Tower, Gold Level<br />

16<br />

1<br />

Horner, West Tower, Silver Level<br />

18<br />

4<br />

McCormick, West Tower, Silver Level<br />

17<br />

19<br />

39<br />

35<br />

3<br />

23<br />

New Orleans, West Tower, Gold Level<br />

Ogden, West Tower, Silver Level<br />

Picasso, West Tower, Bronze Level<br />

20<br />

22<br />

23<br />

24<br />

21 25<br />

26<br />

27<br />

28<br />

GREEN LEVEL<br />

*<br />

29<br />

SWOG<br />

Registration<br />

Desk<br />

39 Plaza Ballrooms, East Tower, Green Level<br />

30 Regency Ballrooms A-D, West Tower, Gold Level<br />

34 San Francisco, West Tower, Gold Level<br />

9 Sandburg, West Tower, Silver Level<br />

26 Soldier Field, West Tower, Bronze Level<br />

33<br />

Toronto, West Tower, Gold Level<br />

10<br />

Truffles, West Tower, Blue Level<br />

30<br />

BRONZE LEVEL<br />

31<br />

32<br />

33<br />

35<br />

34 36<br />

38<br />

37<br />

25 Water Tower, West Tower, Bronze Level<br />

5 Wright, West Tower, Silver Level<br />

28 Wrigley, West Tower, Bronze Level<br />

Restaurants/Bars<br />

19 151-Bistro, Bar and Club, East Tower, Green Level<br />

15 BIG Bar, East Tower, Blue Level<br />

11 DaddyO’s Pub and Piano Bar, West Tower, Blue Level<br />

WEST TOWER<br />

GOLD LEVEL<br />

EAST TOWER<br />

18<br />

12<br />

17<br />

J’s Express, East Tower, Green Level<br />

Pronto Mama’s Italian Kitchen, West Tower, Blue Level<br />

Stetson’s Chop House & Bar, East Tower, Green Level<br />

SWOG • Leading Cancer Research. Together.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 9<br />

CME Credit Information<br />

Procedures for CME Credit<br />

CME credit forms for the <strong>Group</strong> <strong>Meeting</strong> are available on pages<br />

95 and 97 of the <strong>Group</strong> <strong>Meeting</strong> agenda booklet. Only one form<br />

per person is required to list the CME credits for the entire meeting.<br />

Credits for each committee session are listed on the form.<br />

Forms should be turned in to the Registration Desk before the<br />

desk closes at 12:30 p.m. on October 20, <strong>2012</strong>. If the forms are not<br />

turned in to the desk, they can be mailed to the Operations Office the<br />

week following the <strong>Group</strong> <strong>Meeting</strong>. The Operations Office will submit<br />

all CME forms to the accrediting institution at one time. Forms will be<br />

submitted 30 days following the meeting. You will then receive<br />

a certificate of completion in the mail following submission and<br />

processing of the CME forms by the accrediting institution.<br />

<strong>Group</strong> <strong>Meeting</strong> Target Audience and Educational Objectives<br />

SWOG meets semi-annually to keep its members abreast of <strong>Group</strong> science.<br />

The target audience for these meetings are Physicians, Nurse Oncologists<br />

and Clinical Research Associates.<br />

The educational objectives of these meetings are: to educate attendees<br />

about active and proposed studies so that they may implement the studies<br />

at their local institutions; to educate attendees about new treatments<br />

and prevention strategies that are available; to identify areas that can be<br />

improved in cancer research and study implementation and educate attendees<br />

on the best ways to implement the solutions at the local level.<br />

These objectives apply to the following areas: Cancer Control and Prevention,<br />

including Outcomes and Comparative Effectiveness Committee,<br />

Symptom Control and Quality of Life Committee, Prevention Committee,<br />

Molecular Epidemiology Committee, Cancer Survivorship Committee and<br />

Harry Hynes Symposium; Genitourinary Committee; Early Therapeutics<br />

Committee; Myeloma Committee; Melanoma Committee; Surgery Committee;<br />

Radiation Therapy Committee; Plenary Session; Leukemia Committee;<br />

Breast Committee; Gastrointestinal Committee; Lung Committee<br />

and Lymphoma Committee.<br />

SWOG gratefully acknowledges the<br />

support of our CME Commercial Supporters*<br />

*Supporters as of September 10, <strong>2012</strong><br />

Double Platinum Supporters<br />

Eli Lilly & Co.<br />

Platinum Supporters<br />

Amgen<br />

Novartis<br />

Silver Supporters<br />

Genomic Health<br />

Bronze Supporters<br />

Bayer Healthcare Pharmaceuticals<br />

Bristol-Myers Squibb<br />

Eisai<br />

Merck<br />

Sigma-Tau Pharmaceuticals<br />

Varian<br />

Speaker and Planner CME Disclosure Information<br />

Each speaker and planner for The Hope Foundation - CME courses has<br />

been requested to complete a Faculty Disclosure Form prior to the activity.<br />

Information regarding affiliations or interests that might be perceived as a<br />

potential conflict of interest is provided in the agenda book, for everyone<br />

to review.<br />

Continuing Medical Education Credit<br />

The Hope Foundation is accredited by the Accreditation Council for<br />

Continuing Medical Education to provide continuing medical education<br />

for physicians.<br />

The Hope Foundation designates this live activity for a maximum of<br />

22.00 AMA PRA Category 1 Credits. Physicians should only claim<br />

credit commensurate with the extent of their participation in the activity.<br />

SWOG • Leading Cancer Research. Together.


10 <strong>Fall</strong> <strong>2012</strong><br />

Disclosure of Relevant Financial Relationships with Commercial Companies<br />

The Hope Foundation endorses the Standards of the Accreditation Council for Continuing Medical Education and the Guidelines of the<br />

American Medical Association.<br />

The Hope Foundation requires that all presentations at CME activities be fair, balanced, free of commercial bias, and fully supported by<br />

scientific evidence.<br />

Everyone who is in a position to control the content of a continuing medical education activity is required to disclose relevant<br />

relationships with commercial companies whose products or services are discussed in educational presentations. The ACCME<br />

considers relationships of the person involved in the CME activity to include financial relationships of a spouse or partner.<br />

Disclosure of a relationship is not intended to suggest bias in any presentation but is made to provide participants with information that<br />

might be of potential importance to their evaluation of a presentation.<br />

All potential conflicts of interest have been resolved prior to this program.<br />

Acknowledging a relevant relationship with the following companies or organizations having a direct interest in the subject of this<br />

presentation include:<br />

Planner/Faculty Member Nature of Relationship Company<br />

Christine Ambrosone, Ph.D.<br />

Laurence Baker, D.O.<br />

Rick Bangs<br />

Charles Blanke, M.D.<br />

Powell Brown, M.D.<br />

Harry Erba, M.D.<br />

Carol Fabian, M.D.<br />

No Disclosures<br />

No Disclosures<br />

No Disclosures<br />

No Disclosures<br />

No Disclosures<br />

Speaker’s Bureau<br />

Research Grant<br />

No Disclosures<br />

Celgene, Novartis, Incyte<br />

Novartis, Sanofi-Aventis, Ambit, Ascenta, Sunesis, Chroma, Eli-Lilly,<br />

Millennium<br />

A. Mark Fendrick, M.D. Consultant<br />

Speaker’s Bureau<br />

Grant Research<br />

Abbott, AonHewitt, AstraZeneca, Aventis, Blue Shield of CA, BMS,<br />

Center for Medicare and Medicaid Services, Genentech, GSK, Health<br />

Alliance Plan, Highmark BlueCross BlueShield, Merck and Co.,<br />

National Business Coalition on Health, National Pharmaceutical<br />

Council, Neocure <strong>Group</strong> LLC, Pennsylvania State Trooper’s<br />

Association, Pfizer Inc., POZEN Inc., Precision Health Economics<br />

LLC, Thomson Reuters, TriZetto, zanzors<br />

Merck and Co., Pfizer Inc.<br />

Abbott, AstraZeneca, Aventis, Eli Lilly, Genentech, GSK, Merck and<br />

Co., Novartis, Pfizer Inc.<br />

Richard Fisher, M.D. Consultant Roche, Millennium and Pfizer<br />

Lawrence Flaherty, M.D.<br />

Lisa Flynn, M.D.<br />

James Foran, M.D.<br />

Shirish Gadgeel, M.D.<br />

Consultant<br />

Speaker’s Bureau<br />

No Disclosures<br />

No Disclosures<br />

Consultant<br />

Speaker’s Bureau<br />

Research Grant<br />

Genentech, BMS, Merck, Celgene, GSK<br />

Genentech<br />

Boehringer-Ingelheim, Methylgene<br />

Eli-Lilly, Pfizer, Genentech<br />

Clovis Oncology, Pfizer, Infinity, Novartis, Genentech, Chugai, Abbott<br />

SWOG • Leading Cancer Research. Together.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 11<br />

David Gandara, M.D.<br />

Annetine Gelijns, Ph.D.<br />

Heather Greenlee, N.D., Ph.D.<br />

Kenneth Grossmann, M.D.,<br />

Ph.D.<br />

Dawn Hershman, M.D.<br />

Johanna Horn<br />

Consultant<br />

Research Grant<br />

No Disclosures<br />

No Disclosures<br />

No Disclosures<br />

No Disclosures<br />

No Disclosures<br />

Amgen, AstraZeneca, Biodesix, BI, BMS, ImClone, Genentech,<br />

Merck, Novartis, Sanofi-Aventis, Array BioPharma, and Response<br />

Genetics<br />

BMS, ImClone, Genentech, Lilly, Merck, and Novartis.<br />

Gabriel Hortobagyi, M.D. Consultant Allergan, Genentech, Novartis, Sanofi-Aventis, and Taivex<br />

Aly Karsan, M.D., F.R.C.P.C.<br />

No Disclosures<br />

Robert Krouse, M.D. Consultant Novartis<br />

Razelle Kurzrock, M.D.<br />

Monika Leja, M.D.<br />

Bryan Luce, Ph.D., M.B.A.<br />

Thomas Lynch, Jr., M.D.<br />

Research Grant<br />

Honoraria<br />

Consultant<br />

Other<br />

No Disclosures<br />

No Disclosures<br />

Consultant/SAB<br />

Board of Directors and Stock<br />

Holder<br />

Patent Holder<br />

Amgen, Amplimed, Angiochem, Aronex, AstraZeneca, Callisto,<br />

Centocor, Concordia, Enzon, Exelixis, Genentech, Genetics, GSK,<br />

Globomax, GPC Biotech, Hoffman La-Roche, Merck, MGI<br />

Pharmaceuticals, Myriad, NCCN, Nereus, NIH, Novartis, Otsuka,<br />

Pfizer, Ziopharm, and Wyeth.<br />

AACR-MCT, Alfred Mann Foundation, Amgen, ASCO Program<br />

Committee, Cancer Treatment Centers of America, CTRT-EAB,<br />

Exelixis, Georgetown University, Merck, MK&A, Myriad, Novartis,<br />

Optum Heath, Pfizer, Pharmacogenomic Medicine, UTHSCSA,<br />

Yokohama City University and Yonsei Cancer Center.<br />

AACR-MCT, Enzon, Health Advances, LLC, Johnson and Johnson,<br />

Merch, SAIC-Frederick, Inc.<br />

CTRC-EAB, Novartis, AACR, ASCO, Amgen, CTCA, CTRC, Exelisix,<br />

IDSC, Georgetown University, Johnson and Johnson, Merck, Mt.<br />

Sinai School of Medicine, Myriad, Norwegian Radium Hospital, Nova<br />

Research Company, Novartis, Potum Health Oncology, Palladian<br />

Partners, Roche, UTHSCSA<br />

Merck, BI, Astex<br />

Infinity Pharmaceuticals<br />

Partners Healthcare<br />

Frank Meyskens, Jr., M.D. Co-Founder Cancer Prevention Pharmaceuticals<br />

Carol Moinpour, Ph.D.<br />

Paul Okunieff, M.D.<br />

Robert Orlowski, M.D., Ph.D.<br />

Scott Ramsey, M.D.<br />

No Disclosures<br />

No Disclosures<br />

Consultant<br />

Research Grant<br />

No Disclosures<br />

BMS, Onyx, Celgene, Millennium and Abbott<br />

Celgene, Onyx and BMS<br />

Antoni Ribas, M.D. Consultant Amgen, Celgene, Millennium, Genentech-Roche and GSK<br />

Regina Santella, Ph.D.<br />

No Disclosures<br />

SWOG • Leading Cancer Research. Together.


12 <strong>Fall</strong> <strong>2012</strong><br />

Lowell Schnipper, M.D.<br />

Leonard Sender, M.D.<br />

Dana Sparks<br />

Lisa Sparks, Ph.D.<br />

Ian Thompson, Jr., M.D.<br />

Joseph Unger<br />

Courtney Wille<br />

George Yoo, M.D.<br />

Jason Zell, D.O., M.P.H.<br />

Gary Zirpoli, M.A.<br />

No Disclosures<br />

No Disclosures<br />

No Disclosures<br />

No Disclosures<br />

No Disclosures<br />

No Disclosures<br />

No Disclosures<br />

No Disclosures<br />

No Disclosures<br />

No Disclosures<br />

SWOG • Leading Cancer Research. Together.


SCHEDULE OF EVENTS<br />

SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 13<br />

WEDNESDAY, OCTOBER 17, <strong>2012</strong><br />

7:00 a.m. – 7:30 a.m. Medidata RAVE & CRA Clinical<br />

Gold Level<br />

Trials Training Course Check-In<br />

Room: Regency S Foyer<br />

7:30 a.m. – 9:00 a.m. Medidata RAVE Training<br />

Gold Level<br />

Room: Regency AB<br />

7:30 a.m. – 12:30 p.m. CRA Clinical Trials Training<br />

Gold Level<br />

Course (Includes Medidata<br />

Room: Regency AB<br />

RAVE Training)<br />

1:30 p.m. – 5:00 p.m. CRA Clinical Trials Training<br />

Gold Level<br />

Course Practicum<br />

Room: Regency CD<br />

1:00 p.m. – 4:00 p.m. SoCRA Certification Exam<br />

Gold Level<br />

Room: Acapulco<br />

4:00 p.m. – 7:00 p.m. Oncology Research Professionals<br />

Bronze Level<br />

Executive <strong>Meeting</strong> (Committee<br />

Room: Haymarket<br />

Members Only)<br />

Note: The Hope Foundation is accredited by the Accreditation<br />

Council for Continuing Medical Education to provide continuing<br />

medical education for physicians.<br />

The Hope Foundation designates this live activity for a<br />

maximum of 22.00 AMA PRA Category 1 Credits.<br />

Physicians should only claim credit commensurate with the<br />

extent of their participation in the activity.<br />

NOTE: Gray Areas Indicate Workshops<br />

Bolded <strong>Meeting</strong>s Receive CME Credits<br />

THURSDAY, OCTOBER 18, <strong>2012</strong><br />

<strong>Group</strong> <strong>Meeting</strong> Registration & Information Desk<br />

7:00 a.m. - 5:00 p.m. - East Tower Concourse<br />

Hope Foundation Information Desk<br />

8:00 a.m. - 5:00 p.m. - East Tower Concourse<br />

Exhibits & Complimentary Coffee Service<br />

8:00 a.m. - 4:00 p.m. - Toronto<br />

7:00 a.m. – 7:30 a.m. Jeri and Noboru Oishi<br />

Gold Level<br />

Symposium Check-In<br />

Room: Regency S Foyer<br />

7:30 a.m. – 7:45 a.m. Welcome and Information<br />

Gold Level<br />

(Open Session)<br />

Room: Regency AB<br />

7:45 a.m. – 12:30 p.m. Jeri and Noboru Oishi<br />

Room: Regency AB<br />

Symposium (Open Session)<br />

2:00 p.m. – 3:00 p.m. Nursing Committee Special<br />

Gold Level Session B: QOL Coordinators /<br />

Room: Acapulco<br />

Disease & Discipline and<br />

Research Subcommittee<br />

3:00 p.m. – 4:00 p.m. Nursing Committee Special<br />

Bronze Level<br />

Session A: Education & Program<br />

Room: Gold Coast<br />

Subcommittee<br />

8:00 a.m. – 10:00 a.m. Cancer Control and Prevention<br />

Blue Level<br />

Executive Council (Committee<br />

Room: Truffles<br />

Members Only)<br />

8:00 a.m. – 11:00 a.m. Advocates Committee <strong>Meeting</strong><br />

Bronze Level<br />

(Committee Members Only)<br />

Room: Haymarket<br />

SWOG • Leading Cancer Research. Together.


14 <strong>Fall</strong> <strong>2012</strong><br />

SCHEDULE OF EVENTS<br />

THURSDAY, OCTOBER 18, <strong>2012</strong><br />

<strong>Group</strong> <strong>Meeting</strong> Registration & Information Desk<br />

7:00 a.m. - 5:00 p.m. - East Tower Concourse<br />

Hope Foundation Information Desk<br />

8:00 a.m. - 5:00 p.m. - East Tower Concourse<br />

Exhibits & Complimentary Coffee Service<br />

8:00 a.m. - 4:00 p.m. - Toronto<br />

10:15 a.m. – 12:15 p.m. SYMPTOM CONTROL AND<br />

Gold Level<br />

QUALITY OF LIFE<br />

Room: Regency C<br />

COMMITTEE<br />

12:00 p.m. – 2:00 p.m. Quality Initiative <strong>Meeting</strong><br />

Bronze Level<br />

(Committee Members Only)<br />

Room: Haymarket<br />

3:30 p.m. – 4:30 p.m. EARLY THERAPEUTICS<br />

Gold Level<br />

COMMITTEE<br />

Room: Regency AB<br />

4:00 p.m. – 5:30 p.m. Head Clinical Research<br />

Gold Level<br />

Associates (Open to Member,<br />

Room: Acapulco<br />

Affiliate and CCOP Head CRAs<br />

Only)<br />

4:00 p.m. – 6:00 p.m. Conflict of Interest<br />

Bronze Level<br />

Committee (Committee<br />

Room: Picasso<br />

Members Only)<br />

5:30 p.m. – 7:00 p.m. Hope Foundation Platinum<br />

Reception (Invitation Only)<br />

5:30 p.m. – 7:30 p.m. MOLECULAR EPIDEMIOLOGY<br />

Gold Level<br />

COMMITTEE<br />

Room: Regency C<br />

12:30 p.m. – 2:00 p.m. Clinical Research Associates<br />

Gold Level<br />

Open Forum<br />

Room: Regency D<br />

12:45 p.m. – 2:45 p.m. OUTCOMES & COMPARATIVE<br />

Gold Level<br />

EFFECTIVENESS COMMITTEE<br />

Room: Regency C<br />

1:00 p.m. – 2:45 p.m. Translational Medicine<br />

Gold Level<br />

Symposium on Circulating<br />

Room: Regency AB<br />

Tumor Cells<br />

2:30 p.m. – 4:30 p.m. Hope Foundation Annual Board<br />

Gold Level<br />

<strong>Meeting</strong> (Committee Members<br />

Room: San Francisco Only)<br />

3:15 p.m. – 5:15 p.m. PREVENTION COMMITTEE<br />

Gold Level<br />

Room: Regency C<br />

NOTE: Bolded <strong>Meeting</strong>s Receive CME Credits<br />

SWOG • Leading Cancer Research. Together.


SCHEDULE OF EVENTS<br />

SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 15<br />

FRIDAY, OCTOBER 19, <strong>2012</strong><br />

<strong>Group</strong> <strong>Meeting</strong> Registration & Information Desk<br />

7:30 a.m. - 5:00 p.m. - East Tower Concourse<br />

Hope Foundation Information Desk<br />

8:00 a.m. - 5:00 p.m. - East Tower Concourse<br />

Exhibits & Complimentary Coffee Service<br />

7:00 a.m. - 12:00 p.m.; 2:45 p.m. - 4:00 p.m. - Toronto<br />

7:15 a.m. – 9:45 a.m. CANCER SURVIVORSHIP<br />

Bronze Level<br />

COMMITTEE<br />

Room: Comiskey<br />

7:30 a.m. – 9:30 a.m. BARLOGIE-SALMON<br />

Green Level<br />

MYELOMA COMMITTEE<br />

Room: Plaza Ballroom<br />

7:30 a.m. – 9:30 a.m. MELANOMA COMMITTEE<br />

Green Level<br />

Room: Crystal A<br />

8:00 a.m. – 11:30 a.m. Clinical Research Associates<br />

Green Level<br />

Continuing Education Workshop<br />

Room: Crystal B<br />

9:30 a.m. – 11:00 a.m. Quality Assurance Committee<br />

Bronze Level<br />

<strong>Meeting</strong> (Committee Members<br />

Room: Haymarket<br />

Only)<br />

10:00 a.m. – 11:30 a.m. Bone Marrow & Stem Cell<br />

Bronze Level<br />

Transplantation Committee<br />

Room: Gold Coast<br />

10:00 a.m. – 12:00 p.m. CANCER CONTROL AND<br />

Gold Level<br />

PREVENTION OUTREACH<br />

Room: Regency A<br />

(HARRY HYNES<br />

SYMPOSIUM)<br />

10:00 a.m. – 12:00 p.m. SURGERY COMMITTEE<br />

Gold Level<br />

Room: Acapulco<br />

10:00 a.m. – 12:00 p.m. Imaging Committee (Committee<br />

Blue Level<br />

Members Only)<br />

Room: Truffles<br />

11:30 a.m. – 12:15 p.m. Plenary Reception (Light Hors<br />

Gold Level<br />

D’oeuvres)<br />

Room: Regency Foyer<br />

12:15 p.m. – 2:45 p.m. PLENARY SESSION<br />

Gold Level<br />

Room: Regency B-D<br />

3:00 p.m. – 5:00 p.m. Nurse/CRA Planning Committee<br />

Gold Level<br />

(Committee Members Only)<br />

Room: San Francisco<br />

3:00 p.m. – 7:00 p.m. LEUKEMIA COMMITTEE<br />

Green Level<br />

Room: Crystal C<br />

3:00 p.m. – 7:00 p.m. BREAST COMMITTEE<br />

Green Level<br />

Room: Crystal B<br />

5:00 p.m. – 7:00 p.m. GI COMMITTEE<br />

Green Level<br />

Room: Crystal A<br />

5:00 p.m. – 8:00 p.m. SWOG Data & Safety Monitoring<br />

Bronze Level<br />

Committee (Committee Members<br />

Room: Haymarket<br />

Only)<br />

6:45 p.m. – 8:00 p.m. Reception<br />

Gold Level<br />

Room: Regency CD<br />

NOTE: Bolded <strong>Meeting</strong>s Receive CME Credits<br />

SWOG • Leading Cancer Research. Together.


16 <strong>Fall</strong> <strong>2012</strong><br />

SCHEDULE OF EVENTS<br />

SATURDAY, OCTOBER 20, <strong>2012</strong><br />

<strong>Group</strong> <strong>Meeting</strong> Registration & Information Desk<br />

7:30 a.m. - 12:30 p.m. - East Tower Concourse<br />

11:30 a.m. – 3:30 p.m. LYMPHOMA COMMITTEE<br />

Gold Level<br />

Room: Regency C<br />

Hope Foundation Information Desk<br />

8:00 a.m. - 12:30 p.m. - East Tower Concourse<br />

7:00 a.m. – 8:00 a.m. Board of Governors (Board<br />

Gold Level<br />

Members Only)<br />

Room: Regency B<br />

8:15 a.m. – 9:45 a.m. Committee Chairs (Committee<br />

Gold Level<br />

Members Only)<br />

Room: Regency B<br />

8:15 a.m. – 9:45 a.m. S0819 Educational Session for<br />

Gold Level<br />

PIs and CRAs (Invitation Only)<br />

Room: Acapulco<br />

10:15 a.m. – 11:45 a.m. Pharmaceutical Sciences<br />

Gold Level<br />

Committee<br />

Room: New Orleans<br />

10:30 a.m. – 11:30 a.m. Clinical Practices Committee<br />

Gold Level<br />

Room: Acapulco<br />

10:30 a.m. – 12:00 p.m. RADIATION THERAPY<br />

Gold Level<br />

COMMITTEE<br />

Room: San Francisco<br />

11:30 a.m. – 3:30 p.m. GU COMMITTEE<br />

Gold Level<br />

Room: Regency A<br />

11:30 a.m. – 3:30 p.m. LUNG COMMITTEE<br />

Gold Level<br />

Room: Regency B<br />

NOTE: Bolded <strong>Meeting</strong>s Receive CME Credits<br />

SWOG • Leading Cancer Research. Together.


Roster of Committee Speakers<br />

Thursday, October 18, <strong>2012</strong><br />

SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 17<br />

Outcomes and Comparative Effectiveness Committee, 12:45 p.m. - 2:45 p.m. - Regency C<br />

Adaptive Trial Design - Bryan Luce, Ph.D., M.B.A., Director of United Biosource Corporation<br />

The Generalizability of Phase III Cancer Clinical Trial Standard Arm Treatment Outcomes - Joseph M.<br />

Unger, M.S., SWOG Statistical Center<br />

Prevention Committee, 3:15 p.m. - 5:15 p.m. - Regency C<br />

How Young Adult Research Can Be Embedded Into Studies Being Developed in the SWOG Prevention<br />

Committee - Leonard Sender, M.D., Division Chief, Pediatric Oncology, University of California, Irvine<br />

Molecular Epidemiology Committee, 5:30 p.m. - 7:30 p.m. - Regency C<br />

Supplement Use During an Intergroup Clinical Trial for Breast Cancer (S0221) - Gary Zirpoli, M.A.,<br />

Roswell Park Cancer Institute and the University of Buffalo<br />

Friday, October 19, <strong>2012</strong><br />

Cancer Survivorship Committee, 7:15 a.m. - 9:45 a.m. - Comiskey<br />

How Young Adult Research Can Be Embedded Into Studies Being Developed in the SWOG Cancer<br />

Survivorship Committee - Leonard Sender, M.D., Division Chief, Pediatric Oncology, University of California,<br />

Irvine<br />

Use of Social Media to Recruit into SWOG Studies - Lisa Sparks, Ph.D., Chapman University, University of<br />

California, Irvine<br />

Left Ventricular Strain and Serum Troponin to Predict Cardiac Toxicity from Trastuzumab and<br />

Anthracyclines - Monika Leja, M.D., Division of Cardiovascular Medicine, University of Michigan<br />

Melanoma Committee, 7:30 a.m. - 9:30 a.m. - Crystal A Ballroom<br />

How Young Adult Research Can Be Embedded Into Studies Being Developed in the SWOG Melanoma<br />

Committee - Leonard Sender, M.D., Division Chief, Pediatric Oncology, University of California, Irvine<br />

Discussion on the Imaging Initiative - Kenneth F. Grossmann, M.D., Ph.D., University of Utah<br />

Harry E. Hynes CCOP Symposium, 10:00 a.m. - 12:00 p.m. - Regency A<br />

What is Integrative Oncology - Heather Greenlee, N.D., Ph.D., Columbia University Medical Center<br />

Comparative Effectiveness Research: What is it all about - Scott Ramsey, M.D., Ph.D., Fred Hutchinson<br />

Cancer Research Center<br />

SWOG • Leading Cancer Research. Together.


18 <strong>Fall</strong> <strong>2012</strong><br />

Roster of Committee Speakers<br />

Surgery Committee, 10:00 a.m. - 12:00 p.m. - Acapulco<br />

Update: New Agents for Melanoma - Lawrence Flaherty, M.D., Professor, Department of Hematology-<br />

Oncology, Karmanos Cancer Institute, Wayne State University<br />

Update: S0820, “A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent<br />

Recurrence of Colorectal Cancers and Adenomas in Patients with Stage I-III Colon Cancer, Phase III”<br />

- Jason Zell, D.O., M.P.H., Assistant Professor, Division of Hematology/Oncology, Departments of Medicine &<br />

Epidemiology, University of California, Irvine<br />

Surgical Quality Overview - Lisa Flynn, M.D., Assistant Professor of Surgery, Director, Surgical ICU Harper<br />

Hospital, Wayne State University School of Medicine<br />

Breast Committee, 3:00 p.m. - 7:00 p.m. - Crystal B Ballroom<br />

How Young Adult Research Can Be Embedded Into Studies Being Developed in the SWOG Breast<br />

Committee - Leonard Sender, M.D., Division Chief, Pediatric Oncology, University of California, Irvine<br />

SWOG Contributions to Pharmacogenomics - Christine Ambrosone, Ph.D., Professor of Oncology, Chair,<br />

Department of Cancer Control and Prevention, Roswell Park Cancer Institute<br />

Leukemia Committee, 3:00 p.m. - 7:00 p.m. - Crystal C Ballroom<br />

From Genetic to Genomic Testing for Myeloid Malignancy - Aly Karsan, M.D., F.R.C.P.C., Integrative<br />

Oncology-Radiation Biology Unit, BC Cancer Agency<br />

How Young Adult Research Can Be Embedded Into Studies Being Developed in the SWOG Leukemia<br />

Committee - Leonard Sender, M.D., Division Chief, Pediatric Oncology, University of California, Irvine<br />

Saturday, October 20, <strong>2012</strong><br />

Lung Committee, 11:30 a.m. - 3:30 p.m. - Regency B<br />

Optimal Therapy for EGFR Mutant NSCLC: Role of Monoclonal Antibodies and Dual Kinase Inhibitors in<br />

Overcoming Resistance - Thomas Lynch, Jr., M.D., Yale Cancer Center, Yale University<br />

MEK Inhibition in the Therapy of KRAS Mutant NSCLC - Shirish Gadgeel, M.D., Karmanos Cancer Institute,<br />

Wayne State University<br />

SWOG • Leading Cancer Research. Together.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 19<br />

SWOG ADMINISTRATIVE COMMITTEES<br />

Board of Governors<br />

Chair: Laurence H. Baker, D.O.<br />

Bone Marrow and Stem Cell Transplantation Committee<br />

Chair: Stephen J. Forman, M.D.<br />

Clinical Practices Committee<br />

Chair: Saul E. Rivkin, M.D.<br />

Conflict of Interest Committee<br />

Chair: Vernon K. Sondak, M.D.<br />

Membership Committee<br />

Chair: James K. Weick, M.D.<br />

Pharmaceutical Sciences Committee<br />

Chair: Siu-Fun Wong, Pharm.D.<br />

Professional Review Committee<br />

Chair: Primo N. Lara, Jr., M.D.<br />

Oncology Research Professionals Committee<br />

Chair: Rose B. Ermete, R.N., B.S.N.<br />

Quality Assurance Committee<br />

Chair: Manuel Valdivieso, M.D.<br />

Radiation Therapy Committee<br />

Chair: Paul Okunieff, M.D.<br />

Surgery Committee<br />

Chair: George H. Yoo, M.D.<br />

SWOG • Leading Cancer Research. Together.


20 <strong>Fall</strong> <strong>2012</strong><br />

Your donation<br />

gives hope.<br />

We invest because your work is invaluable to<br />

SWOG and to our common mission of preventing<br />

and treating cancer.<br />

All investors will be entered to win up to $10,000 in outstanding<br />

prizes at the SWOG Reception on Friday, October 19 at 6:45 pm,<br />

Regency Ballroom C, The Hyatt Regency Chicago.<br />

Entries must be received by 12:00 pm on October 19, <strong>2012</strong>.<br />

Entrants must be present to win.<br />

The Hope Foundation, a nonprofit organization, is the philanthropic<br />

arm of SWOG, and accepts investments from individuals, corporations<br />

and foundations. In support of SWOG’s mission to eradicate cancer,<br />

90% of all contributions are directly invested in programming.<br />

Hope Foundation Information Desk: Foyer, East Tower Concourse, Thursday - Saturday<br />

Johanna (Jo) Horn, Executive Director | jo@thehopefoundation.org | 734-998-7150 | www.thehopefoundation.org<br />

SWOG • Leading Cancer Research. Together.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 21<br />

Jeri and Noboru Oishi Symposium<br />

Thursday, October 18, <strong>2012</strong> - 7:45 a.m. - 12:30 p.m.<br />

Location: Regency AB (Gold Level, West Tower)<br />

Topic: Consent: More Than Just a Piece of Paper<br />

Special Symposia<br />

Featured Speakers:<br />

• Ethic/Legal Issues of Consent - Michael Roach, J.D.<br />

• AccrualNet/Recruitment of Underserved Populations - Linda Parreco, R.N., M.S.<br />

• Communication of Consent/Research - Terry Albrecht, Ph.D.<br />

• Explain Consent Template Changes - Jeanne Alder, R.N., M.P.H., C.C.R.P.<br />

• Trials and Tribulation of a Trial Candidate - Susan Steel, B.A.<br />

This activity has been submitted to the Oncology Nursing Society for approval to award contact hours. ONS is accredited as an approver<br />

of continuing nursing education by the American Nurses Credentialing Center’s COA.<br />

Certificates for continuing education credits (CEUs) will be distributed to attendees upon completion and return of their evaluation<br />

sheets. Certificates of attendance will be given for Society of Clinical Research Associates.<br />

Clinical Research Associates Open Forum<br />

Thursday, October 18, <strong>2012</strong> - 12:30 p.m. - 2:00 p.m.<br />

Location: Regency D (Gold Level, West Tower)<br />

Topic: This forum offers an opportunity to get answers to your clinical trial questions and address the science and technical<br />

research issues that challenge us today.<br />

Featured Topics:<br />

• Quality Assurance Audits<br />

• CTCAE/SAE Reporting<br />

• The Wild World of Regulatory Affairs<br />

• Data Management Tips & Tools for CRAs<br />

• Cancer Treatment Modalities<br />

• Specimen Preparation and Shipment<br />

• SWOG Federal & CTI Non-Federal Reimbursement<br />

• Hot Topics in CRA Site Administration<br />

SWOG • Leading Cancer Research. Together.


22 <strong>Fall</strong> <strong>2012</strong><br />

CRA Continuing Education Workshop<br />

Friday, October 19, <strong>2012</strong> - 8:00 a.m. - 11:30 a.m.<br />

Location: Crystal B Ballroom (Green Level, West Tower)<br />

Title: Lung Cancer<br />

Special Symposia<br />

Featured Speakers:<br />

• Lung Cancer Staging - Jared Acoba, M.D.<br />

• Lung Cancer Translational Medicine - Philip C. Mack, Ph.D.<br />

• New Lung Cancer Trials - David R. Gandara, M.D.<br />

• Roadblocks to Enrollment - Annette Betley, B.S.<br />

• Drug and Skin Toxicities - Siu-Fun Wong, Pharm.D., F.A.S.H.P., F.C.S.H.P.<br />

• Helping Patients Transition to Survivorship - Amita Patel, M.D., C.M.D., M.H.A., C.P.E.<br />

• SWOG Update - Jackie Benedetti, Ph.D.<br />

SWOG • Leading Cancer Research. Together.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 23<br />

Membership Accrual by Institution<br />

All Credited Registrations* (Excluding Correlatives)<br />

July 1, 2011 - June 30, <strong>2012</strong><br />

SWOG Treatment<br />

SWOG Endorsed/<br />

non-SWOG Intergroup<br />

Cancer Control &<br />

Prevention**<br />

MEMBERS/AFFILIATES<br />

Arizona, U of (3009) 16 15 0 31<br />

Arkansas, U of (101) 7 21 0 28<br />

Highlands Onc <strong>Group</strong> (10885) 0 0 2 2<br />

MD Anderson, Florida (10955) 7 3 0 10<br />

Mercy Hosp Ft Smith (8262) 0 1 0 1<br />

NEA Baptist Clinic (17124) 1 2 0 3<br />

NEA Baptist Mem Hosp (11728) 2 0 1 3<br />

Sacred Heart Med Onc (10549) 6 0 9 15<br />

BC Cancer Agency (14112) 9 6 0 15<br />

Baylor College (11988) 21 5 0 26<br />

Baylor Univ Med Ctr (14205) 0 6 0 6<br />

Brooke Army Med Ctr (10330) 0 1 0 1<br />

Madigan Army Med Ctr (11460) 15 3 0 18<br />

S Georgia Med Ctr (10807) 2 7 0 9<br />

Cedars-Sinai Med Ctr (14111) 31 2 0 33<br />

Cincinnati MC, U of (10509) 2 4 8 14<br />

Central Baptist Hosp (11292) 0 0 2 2<br />

Good Samaritan Hosp (11488) 10 0 0 10<br />

City of Hope Med Ctr (10082) 35 8 13 56<br />

Cleveland Clinic OH (301) 42 35 0 77<br />

Akron Gen Med Ctr (8217) 0 8 7 15<br />

Mansfield Gen Hosp (10934) 3 1 0 4<br />

Colorado, U of (10120) 45 31 0 76<br />

Mem Hosp, Co Springs (10436) 3 4 6 13<br />

Poudre Valley Hosp (11190) 2 7 11 20<br />

Columbia University (10769) 0 16 8 24<br />

Nyack Hospital (11412) 2 1 0 3<br />

Orange Reg Med Ctr (10889) 2 1 3 6<br />

St Luke's-Roosevelt (10892) 4 7 0 11<br />

Valley Hospital (10926) 1 3 0 4<br />

Winthrop - Univ Hosp (11492) 2 3 0 5<br />

Davis, U of CA (10176) 53 32 9 94<br />

California Ca Ctr (10733) 4 0 0 4<br />

John Muir Med Ctr (10323) 0 1 0 1<br />

Loma Linda Univ (10682) 10 0 0 10<br />

NorthBay Med Ctr (10180) 0 0 2 2<br />

*Registrations used for membership credit. All SWOG studies (excluding correlatives) and SWOG Endorsed registrations count toward SWOG minimum accrual requirements.<br />

**Includes S0702 and S1105.<br />

Total<br />

SWOG • Leading Cancer Research. Together.


24 <strong>Fall</strong> <strong>2012</strong><br />

Membership Accrual by Institution<br />

All Credited Registrations* (Excluding Correlatives)<br />

July 1, 2011 - June 30, <strong>2012</strong><br />

SWOG Treatment<br />

SWOG Endorsed/<br />

non-SWOG Intergroup<br />

Cancer Control &<br />

Prevention**<br />

Sierra Nevada Mem (10890) 0 0 1 1<br />

St Elizabeth's MC (11173) 4 7 1 12<br />

Sutter Hlth CRG-East (10712) 13 0 0 13<br />

Sutter Hlth Western (10714) 0 10 0 10<br />

Fox Chase Cancer Ctr (13926) 1 0 0 1<br />

Galveston, U of TX (601) 1 2 5 8<br />

H Lee Moffitt CC (11898) 15 21 30 66<br />

Broward Gen Med Ctr (11938) 0 0 9 9<br />

Leesburg Reg Med Ctr (14513) 0 0 2 2<br />

Martin Memorial CC (11941) 1 0 0 1<br />

Space Coast Med Asso (11930) 0 0 16 16<br />

St Joseph's/Candler (11980) 3 1 0 4<br />

Watson Clinic Center (11935) 0 8 0 8<br />

Harrington CC (11446) 2 5 12 19<br />

Henry Ford Hosp (501) 17 3 4 24<br />

Breslin Cancer Ctr (10415) 7 0 5 12<br />

Irvine, U of CA (10498) 9 5 0 14<br />

Long Beach Mem MC (10617) 6 0 0 6<br />

Northridge Hosp (11580) 1 0 0 1<br />

Presbyterian Hosp (11524) 0 2 0 2<br />

St Jude Medical Ctr (11553) 2 1 0 3<br />

KaiserPermanenteNCAL (13655) 11 117 0 128<br />

KaiserPermanenteCOL (15184) 4 7 0 11<br />

KaiserPermanenteSCAL (15468) 17 58 0 75<br />

Kansas, U of (3004) 33 30 1 64<br />

Good Samaritan Hosp (10628) 1 1 1 3<br />

Stormont-Vail Health (10496) 4 1 6 11<br />

Kentucky, U of (10012) 36 15 0 51<br />

Lahey Clinic Med Ctr (16037) 6 8 5 19<br />

Loyola University (10080) 39 16 39 94<br />

Edward Hospital (12848) 4 2 1 7<br />

Hem-Onc Consultants (10616) 0 1 0 1<br />

Quad Cities/Genesis (10424) 0 1 0 1<br />

MD Anderson (11439) 80 1 0 81<br />

MUSC, Hollings CC (11421) 13 8 2 23<br />

Lexington Med Ctr (12448) 2 0 0 2<br />

Methodist Hospital (15225) 1 0 1 2<br />

*Registrations used for membership credit. All SWOG studies (excluding correlatives) and SWOG Endorsed registrations count toward SWOG minimum accrual requirements.<br />

**Includes S0702 and S1105.<br />

Total<br />

SWOG • Leading Cancer Research. Together.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 25<br />

Membership Accrual by Institution<br />

All Credited Registrations* (Excluding Correlatives)<br />

July 1, 2011 - June 30, <strong>2012</strong><br />

SWOG Treatment<br />

SWOG Endorsed/<br />

non-SWOG Intergroup<br />

Cancer Control &<br />

Prevention**<br />

Michigan, U of (4700) 54 31 2 87<br />

Mississippi, Univ of (3012) 5 2 6 13<br />

NE Alabama Reg MC (12075) 0 1 0 1<br />

NE Georgia Med Ctr (11339) 3 8 9 20<br />

Singing River Hosp (12057) 5 4 5 14<br />

St Joseph Hospital (11546) 0 3 3 6<br />

Oregon Hlth Sci Univ (4100) 17 9 0 26<br />

Asante-Rogue Med Ctr (8290) 2 1 6 9<br />

Good Samaritan Hosp (14039) 1 9 6 16<br />

Mid-Columbia Med Ctr (15175) 0 2 0 2<br />

Salem Hospital (8167) 2 1 0 3<br />

Providence Hosp (3500) 8 6 7 21<br />

Puget Sound (3007) 19 18 3 40<br />

Bay Area Hospital (11340) 5 0 6 11<br />

Columbia Basin Hem (12626) 1 0 4 5<br />

Harrison Bremerton (11548) 2 2 10 14<br />

Highline Cancer Ctr (16249) 0 1 0 1<br />

Minor & James Med (12135) 0 0 1 1<br />

Rockwood Clinic, PS (11435) 4 0 0 4<br />

Skagit Valley Hosp (10666) 2 2 2 6<br />

St Charles Hlth Sys (10359) 7 2 1 10<br />

St Joseph Hospital (10023) 4 2 0 6<br />

St Mary Med Ctr (11450) 0 5 0 5<br />

Wenatchee Valley (8214) 1 0 2 3<br />

Yakima Valley Mem (10620) 1 0 0 1<br />

Rochester, Univ of (11400) 61 21 0 82<br />

Arnot Ogden Med Ctr (13424) 1 0 8 9<br />

San Antonio, U of TX (2400) 56 9 6 71<br />

Carolinas Med Ctr (17374) 0 1 0 1<br />

SW Cancer & Res Ctr (8215) 5 0 0 5<br />

Sinai Hospital (11184) 12 4 0 16<br />

TX Oncology-Central (15251) 10 0 0 10<br />

Thompson Ca Surv Ctr (10427) 2 8 0 10<br />

So Calif, U of (10138) 40 26 1 67<br />

Desert Hospital (11205) 4 10 0 14<br />

St Joseph Med Ctr (10283) 3 3 0 6<br />

St Louis University (10357) 4 3 5 12<br />

*Registrations used for membership credit. All SWOG studies (excluding correlatives) and SWOG Endorsed registrations count toward SWOG minimum accrual requirements.<br />

**Includes S0702 and S1105.<br />

Total<br />

SWOG • Leading Cancer Research. Together.


26 <strong>Fall</strong> <strong>2012</strong><br />

Membership Accrual by Institution<br />

All Credited Registrations* (Excluding Correlatives)<br />

July 1, 2011 - June 30, <strong>2012</strong><br />

SWOG Treatment<br />

SWOG Endorsed/<br />

non-SWOG Intergroup<br />

Cancer Control &<br />

Prevention**<br />

Christian Hosp NE/NW (11878) 0 0 1 1<br />

Stanford University (12661) 10 5 0 15<br />

Tennessee, U of (11441) 6 8 0 14<br />

Cookeville Reg MC (13433) 2 0 1 3<br />

Tulane University (1801) 3 1 0 4<br />

Baton Rouge Clinic (15717) 2 1 0 3<br />

Univ of Chicago MC (13924) 1 0 0 1<br />

Univ of Chicago MC (15493) 1 0 0 1<br />

Univ of Maryland (15076) 1 0 0 1<br />

Utah, U of (2501) 19 34 27 80<br />

McKay-Dee Hospital (8082) 0 0 11 11<br />

St Luke's Mt State (8081) 6 6 0 12<br />

Utah Valley Reg Med (8315) 3 0 3 6<br />

Wayne State Univ (2701) 37 16 0 53<br />

MidMichigan Med Ctr (11812) 1 3 0 4<br />

Mt Clemens Reg MC (10058) 1 0 1 2<br />

N Michigan Reg Hosp (10697) 1 0 0 1<br />

Univ of Louisville (11293) 3 0 0 3<br />

Yale University (17377) 4 1 0 5<br />

Member & Affiliate Total 1112 834 359 2305<br />

CCOPS/MBCCOPS<br />

Atlanta Reg CCOP (10225) 22 14 13 49<br />

Bay Area CCOP (10706) 4 6 4 14<br />

Beaumont CCOP (11434) 7 19 5 31<br />

Boston MC MBCCOP (16686) 2 2 0 4<br />

Central IL CCOP (10211) 50 35 53 138<br />

Columbia River CCOP (10251) 6 3 16 25<br />

Columbus CCOP (9005) 27 4 5 36<br />

Dayton CCOP (9006) 26 3 16 45<br />

Grand Rapids CCOP (9007) 15 5 7 27<br />

Greenville CCOP (10879) 18 6 5 29<br />

Gulf Coast MBCCOP (11370) 3 1 5 9<br />

Hawaii MBCCOP, U of (10781) 17 16 5 38<br />

Kansas City CCOP (9010) 23 10 12 45<br />

LSU-New Orleans CCOP (10816) 3 6 0 9<br />

LSU-Shreveport CCOP (13521) 13 3 19 35<br />

Michigan CRC CCOP (11110) 72 0 16 88<br />

*Registrations used for membership credit. All SWOG studies (excluding correlatives) and SWOG Endorsed registrations count toward SWOG minimum accrual requirements.<br />

**Includes S0702 and S1105.<br />

Total<br />

SWOG • Leading Cancer Research. Together.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 27<br />

Membership Accrual by Institution<br />

All Credited Registrations* (Excluding Correlatives)<br />

July 1, 2011 - June 30, <strong>2012</strong><br />

SWOG Treatment<br />

SWOG Endorsed/<br />

non-SWOG Intergroup<br />

Cancer Control &<br />

Prevention**<br />

Montana CCOP (10891) 20 4 9 33<br />

New Mexico MBCCOP (11331) 27 9 4 40<br />

Northwest CCOP (9016) 17 26 18 61<br />

Ozarks Reg CCOP (10210) 18 9 2 29<br />

Scott & White CCOP (10940) 1 2 11 14<br />

Southeast CCC CCOP (11108) 55 8 21 84<br />

Southern Nevada CCOP (13500) 17 0 0 17<br />

St Louis CCOP (9015) 11 17 23 51<br />

Upstate Carolina (10122) 13 9 4 26<br />

Virginia Mason CCOP (9011) 13 11 18 42<br />

Wichita CCOP (9017) 26 20 26 72<br />

CCOP/MBCCOP Total 526 248 317 1091<br />

UCOPS<br />

Baylor College-UCOP (10310) 2 0 0 2<br />

Henry Ford-UCOP (10703) 7 0 0 7<br />

LSU-Shreveport UCOP (10704) 4 0 0 4<br />

Loyola Univ - UCOP (10298) 3 0 0 3<br />

Michigan, U of-UCOP (11386) 7 0 0 7<br />

Oklahoma, U of-UCOP (10788) 14 0 0 14<br />

PSOC UCOP (10300) 8 0 0 8<br />

So Calif, U of-UCOP (10312) 1 0 0 1<br />

Urology Ctr of CO (13800) 13 0 0 13<br />

Utah, U of - UCOP (10313) 25 0 0 25<br />

UCOP Total 84 0 0 84<br />

FOREIGN<br />

INCan (15434) 10 0 32 42<br />

King Faisal Spec Hos (13697) 0 0 15 15<br />

National Cancer Ctr (15484) 6 0 0 6<br />

Foreign Total 16 0 47 63<br />

Other <strong>Group</strong>s<br />

ACOSOG 16 0 0 16<br />

AMC 3 0 0 3<br />

CALGB 254 0 40 294<br />

ECOG 393 0 63 456<br />

GOG 3 0 0 3<br />

NCCTG 185 0 67 252<br />

NCIC 4 0 0 4<br />

*Registrations used for membership credit. All SWOG studies (excluding correlatives) and SWOG Endorsed registrations count toward SWOG minimum accrual requirements.<br />

**Includes S0702 and S1105.<br />

Total<br />

SWOG • Leading Cancer Research. Together.


28 <strong>Fall</strong> <strong>2012</strong><br />

Membership Accrual by Institution<br />

All Credited Registrations* (Excluding Correlatives)<br />

July 1, 2011 - June 30, <strong>2012</strong><br />

SWOG Treatment<br />

SWOG Endorsed/<br />

non-SWOG Intergroup<br />

Cancer Control &<br />

Prevention**<br />

NCIC-CTG 22 0 0 22<br />

NSABP 60 0 2 62<br />

RTOG 18 0 0 18<br />

Other <strong>Group</strong>s Total 958 0 172 1130<br />

Grand Total 2696 1082 895 4673<br />

*Registrations used for membership credit. All SWOG studies (excluding correlatives) and SWOG Endorsed registrations count toward SWOG minimum accrual requirements.<br />

**Includes S0702 and S1105.<br />

Total<br />

SWOG • Leading Cancer Research. Together.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 29<br />

Membership Accrual by Institution and Committee<br />

All Credited Registrations* (Excluding Correlatives)<br />

July 1, 2011 - June 30, <strong>2012</strong><br />

Total<br />

Breast<br />

Cancer Survivorship<br />

GU<br />

Early Therapeutics<br />

GI<br />

Arizona, U of 31 10 - - - - - - 4 10 5 2 - - -<br />

Arkansas, U of 62 10 - - 10 10 - 3 1 3 13 - - - 12<br />

Atlanta Reg CCOP 49 22 - - 1 7 - - 5 - - 1 - - 13<br />

BC Cancer Agency 15 6 - - 3 6 - - - - - - - - -<br />

Bay Area CCOP 14 9 - - - - - - 1 - - - - - 4<br />

Baylor College 26 - - - 5 12 - 5 3 - - 1 - - -<br />

Baylor College-UCOP 2 - - - - 2 - - - - - - - - -<br />

Baylor Univ Med Ctr 6 - - - - - - - - - 6 - - - -<br />

Beaumont CCOP 31 21 - - - 4 - - - - 1 - - - 5<br />

Boston MC MBCCOP 4 - - - 3 - - - - 1 - - - - -<br />

Brooke Army Med Ctr 28 9 - - 1 16 - - - 2 - - - - -<br />

Cedars-Sinai Med Ctr 33 1 - - 23 9 - - - - - - - - -<br />

Central IL CCOP 138 39 - - 13 9 - 1 15 3 - 5 - - 53<br />

Cincinnati MC, U of 26 6 - - 5 - - - 3 - 2 - - - 10<br />

City of Hope Med Ctr 56 10 - - 1 15 - 6 2 9 - - - 3 10<br />

Cleveland Clinic OH 96 46 - - 5 17 - 6 - 4 - 11 - - 7<br />

Colorado, U of 109 22 - - 11 29 1 3 17 - 8 1 - - 17<br />

Columbia River CCOP 25 4 - - 3 - - 2 - - - - - - 16<br />

Columbia University 53 27 - - 3 4 - - 3 2 2 1 2 1 8<br />

Columbus CCOP 36 24 - - 3 - - 1 2 - 1 - 1 - 4<br />

Davis, U of CA 147 33 - - 8 45 - 7 27 8 5 1 - - 13<br />

Dayton CCOP 45 7 - - 4 7 - - 7 2 1 1 - - 16<br />

Fox Chase Cancer Ctr 1 - - - - - 1 - - - - - - - -<br />

Galveston, U of TX 8 - - - 2 1 - - - - - - - - 5<br />

Grand Rapids CCOP 27 4 - - 3 3 - - 8 - 2 - - - 7<br />

Greenville CCOP 29 6 - - - - - 2 13 - 1 2 3 - 2<br />

Gulf Coast MBCCOP 9 1 - - 1 2 - - - - - - - - 5<br />

H Lee Moffitt CC 106 11 - - 3 6 - 7 5 - 10 7 - - 57<br />

Harrington CC 19 4 - - 1 - - - 1 1 - - - - 12<br />

Hawaii MBCCOP, U of 38 19 - - 4 - - 1 2 4 1 2 - - 5<br />

Henry Ford Hosp 43 14 - 3 - 10 - - 6 1 - - - - 9<br />

INCan 42 9 - - - - - - 1 - - - - - 32<br />

Irvine, U of CA 26 6 - - 7 1 - 2 7 - 1 2 - - -<br />

KaiserPermanenteNCAL 214 159 - - 37 1 - 3 8 2 1 3 - - -<br />

Kansas City CCOP 45 17 - - 1 1 - 2 7 3 - 2 - - 12<br />

Kansas, U of 78 11 - - 22 12 - 2 21 1 1 - 1 - 7<br />

Kentucky, U of 51 8 - - 2 9 - 13 13 5 - 1 - - -<br />

King Faisal Spec Hos 15 - - - - - - - - - - - - - 15<br />

LSU-New Orleans CCOP 9 - - - 3 1 - - 1 3 - 1 - - -<br />

LSU-Shreveport CCOP 39 6 - - 1 8 - - 1 1 1 2 - - 19<br />

Lahey Clinic Med Ctr 19 3 - - - - - 1 6 - 4 - - 5 -<br />

Loyola University 106 17 1 - 6 19 - 13 6 4 1 - - - 39<br />

MD Anderson 81 40 - - 5 14 2 3 16 1 - - - - -<br />

MUSC, Hollings CC 25 9 - - 1 3 - 7 1 2 - - - - 2<br />

Methodist Hospital 2 1 - - - - - - - - - - - - 1<br />

Michigan CRC CCOP 88 40 - - 4 7 - - 15 3 - 3 - - 16<br />

GYN<br />

Leukemia<br />

Lung<br />

Lymphoma<br />

Melanoma<br />

Myeloma<br />

Outcomes<br />

Prevention<br />

Symptom Control & QOL<br />

*Registrations used for membership credit. Affiliate Accrual Reported with Main Member Institution.<br />

SWOG • Leading Cancer Research. Together.


30 <strong>Fall</strong> <strong>2012</strong><br />

Membership Accrual by Institution and Committee<br />

All Credited Registrations* (Excluding Correlatives)<br />

July 1, 2011 - June 30, <strong>2012</strong><br />

Total<br />

Breast<br />

Cancer Survivorship<br />

GU<br />

Early Therapeutics<br />

GI<br />

Michigan, U of 87 38 - - 5 28 - 3 4 5 2 - - - 2<br />

Michigan, U of-UCOP 7 - - - - 7 - - - - - - - - -<br />

Mississippi, Univ of 54 18 - - 1 1 1 2 5 2 1 - - - 23<br />

Montana CCOP 33 9 - - 3 3 - 1 1 1 1 5 - - 9<br />

National Cancer Ctr 6 6 - - - - - - - - - - - - -<br />

New Mexico MBCCOP 40 31 - - 2 - - 1 - - - 2 - - 4<br />

Northwest CCOP 61 31 - - 2 - - - 10 - - - - - 18<br />

Oklahoma, U of-UCOP 14 - - - - 14 - - - - - - - - -<br />

Oregon Hlth Sci Univ 56 12 - - 7 17 - - 3 2 3 - - - 12<br />

Ozarks Reg CCOP 29 10 - - 10 2 1 - 1 - 3 - 1 - 1<br />

Providence Hosp 21 3 - - 2 - - - 5 - - 4 - - 7<br />

Puget Sound 115 27 - - 8 24 2 5 5 10 5 - - - 29<br />

Rochester, Univ of 91 6 - - 5 13 - 18 3 34 2 2 - - 8<br />

San Antonio, U of TX 113 27 - 2 2 46 - 2 20 - 6 2 - - 6<br />

Scott & White CCOP 14 - - - 2 1 - - - - - - - - 11<br />

So Calif, U of 88 36 - 1 24 12 - - 12 1 - 1 - - 1<br />

Southeast CCC CCOP 84 15 - - 9 10 - 1 14 2 5 7 - - 21<br />

Southern Nevada CCOP 17 1 - - - 8 - - 5 - - 3 - - -<br />

St Louis CCOP 51 11 - - - 6 - 2 5 - 2 2 - 1 22<br />

St Louis University 13 1 - - 1 2 - 1 - 2 - - - - 6<br />

Stanford University 15 - - - - - - 15 - - - - - - -<br />

Tennessee, U of 17 9 - - 3 1 - 1 2 - - - - - 1<br />

Tulane University 7 5 - - 1 - - - 1 - - - - - -<br />

Univ of Chicago MC 2 - - - - - 1 - - - 1 - - - -<br />

Univ of Maryland 1 - - - - - 1 - - - - - - - -<br />

Upstate Carolina 26 12 - - 2 - - - 5 1 1 1 - - 4<br />

Urology Ctr of CO 13 - - - - 13 - - - - - - - - -<br />

Utah, U of 134 35 - - 2 39 - 1 11 - 4 1 - 2 39<br />

Virginia Mason CCOP 42 12 - - - 10 - - 2 - - - - - 18<br />

Wayne State Univ 63 27 - - 6 13 - 3 9 1 2 1 - - 1<br />

Wichita CCOP 72 16 - - 9 5 3 3 3 5 1 1 - - 26<br />

Yale University 5 2 - - 1 - - - 2 - - - - - -<br />

SWOG Total 3,543 1,091 1 6 312 565 13 149 356 141 106 81 8 12 702<br />

ACOSOG 16 11 - - 1 - - - 4 - - - - - -<br />

AMC 3 - - - - - - - - 3 - - - - -<br />

CALGB 294 102 - - 14 32 - 23 28 52 - 3 - - 40<br />

ECOG 456 185 - - 16 52 - 11 43 48 - 38 - - 63<br />

GOG 3 3 - - - - - - - - - - - - -<br />

NCCTG 252 116 - - 12 15 - - 33 5 - 4 - - 67<br />

NCIC 4 4 - - - - - - - - - - - - -<br />

NCIC-CTG 22 22 - - - - - - - - - - - - -<br />

NSABP 62 54 - - 1 2 - - 2 1 - - - - 2<br />

RTOG 18 10 - - 5 - - - 2 - - 1 - - -<br />

Other <strong>Group</strong> Total 1,130 507 - - 49 101 - 34 112 109 - 46 - - 172<br />

Grand Total 4,673 1,598 1 6 361 666 13 183 468 250 106 127 8 12 874<br />

GYN<br />

Leukemia<br />

*Registrations used for membership credit. Affiliate Accrual Reported with Main Member Institution.<br />

Lung<br />

Lymphoma<br />

Melanoma<br />

Myeloma<br />

Outcomes<br />

Prevention<br />

Symptom Control & QOL<br />

SWOG • Leading Cancer Research. Together.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 31<br />

BARLOGIE-SALMON MYELOMA COMMITTEE<br />

Committee Leadership<br />

Chair:<br />

Vice-Chair:<br />

Executive Officer:<br />

Statisticians:<br />

Scientific Leadership<br />

Translational Medicine:<br />

Radiation:<br />

Surgery:<br />

Pathology:<br />

Early Therapeutics:<br />

Designates<br />

Clinical Research Associates:<br />

CCOP Representative:<br />

Data Coordinators:<br />

Nurses:<br />

Patient Advocate:<br />

Pharmaceutical Science:<br />

Protocol Coordinator:<br />

Friday, October 19, <strong>2012</strong><br />

Room: Plaza Ballroom<br />

7:30 a.m. – 9:30 a.m.<br />

Presentations<br />

Time/Location<br />

Agenda<br />

Robert Z. Orlowski, M.D., Ph.D.<br />

Brian G.M. Durie, M.D.<br />

Harry P. Erba, M.D., Ph.D.<br />

Antje Hoering, Ph.D.<br />

Rachael Sexton, M.S.<br />

Joshua Epstein, D.Sc.<br />

Srinivasan Vijayakumar, M.D.<br />

J. Sybil Biermann, M.D.<br />

Robert B. Lorsbach, M.D., Ph.D.<br />

Frits van Rhee, M.D., Ph.D.<br />

Ellen Chase, B.S.<br />

James D. Bearden, III, M.D.<br />

Jeri Jardine<br />

Laura Kingsbury<br />

Tracy Maher, C.C.R.P.<br />

Steven M. Burt, R.N.<br />

Deborah A. Halk, R.N.<br />

Byron Lee<br />

Lara M. Au, Pharm.D.<br />

Holly O. Chan, Pharm.D.<br />

Sandi Fredette<br />

Active Studies<br />

■■<br />

S0702, “A Prospective Observational Multicenter Cohort Study<br />

to Assess The Incidence of Osteonecrosis of the Jaw (ONJ) in<br />

Cancer Patients with Bone Metastases Starting Zoledronic Acid<br />

Treatment.” Dr. Van Poznak. Activated: 12/15/08.<br />

■■<br />

■■<br />

CTSU/CTN0702, “A Trial of Single Autologous Transplant with<br />

or without Consolidation Therapy versus Tandem Autologous<br />

Transplant with Lenalidomide Maintenance for Patients with<br />

Multiple Myeloma.” Dr. Van Rhee. Activated: 3/15/10.<br />

CTSU/E3A06, Genomic and Immunology Studies for E3A06,<br />

“Randomized Phase III Trial of Lenalidomide versus Observation<br />

Alone in Patients with Asymptomatic Smoldering Multiple<br />

Myeloma.” Dr. Dhodapkar. Activated: 2/1/11.<br />

Closed Studies<br />

■■<br />

S0777, “A Randomized Phase III Trial of CC-5013 (Lenalidomide,<br />

NSC-703813) and Low Dose Dexamethasone (LLD) versus<br />

Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose<br />

Dexamethasone (BLLD) for Induction, in Patients with Previously<br />

Untreated Multiple Myeloma without an Intent for Immediate<br />

Autologous Stem Cell Transplant.” Dr. Durie. Activated:<br />

2/28/08; Closed: 2/1/12.<br />

■■<br />

■■<br />

S0833, “Total Therapy 3 (TT3) for Newly Diagnosed Patients<br />

with Multiple Myeloma (MM): A Southwest Oncology <strong>Group</strong> Trial<br />

for Patients Aged < 65 Years.” Dr. Abidi. Activated: 4/1/11;<br />

Closed: 5/1/12.<br />

CTSU/E4A08, “A Randomized Phase III Trial of Melphalan and<br />

Dexamethasone (MDex) versus Bortezomib, Melphalan and<br />

Dexamethasone (BMDex) for Untreated Patients with Systemic<br />

Light-chain (AL) Amyloidosis Ineligible for Autologous Stem-cell<br />

Transplantation.” Dr. Zonder. Activated: 12/15/10; Closed:<br />

9/7/12.<br />

Proposed Studies<br />

■■<br />

S1211, “A Phase II Study of Optimal Induction Therapy for<br />

Newly Diagnosed High Risk Multiple Myeloma (HRMM).” Dr.<br />

Usmani.<br />

■■<br />

■■<br />

S1224, “A Phase I/II Study to Evaluate the Safety and Efficacy<br />

of MK-1775 (NSC-XXXX) (Wee1 Kinase Inhibitor) in Combination<br />

with Bortezomib and Pegylated Liposomal Doxorubicin in<br />

Patients with Relapsed and/or Refractory Multiple Myeloma and<br />

Defined p53 Status.” Dr. Abidi.<br />

S1304, “A Phase II Randomized Study Comparing Two Doses<br />

of Carfilzomib (NSC-XXXX) with Dexamethasone for Multiple<br />

Myeloma Patients with Relapsed or Refractory Disease.” Dr.<br />

Ailawadhi.<br />

■■<br />

SXXXX, “Phase III Study of Lenalidomide vs. Lenalidomide +<br />

MLN9708 as Maintenance Therapy Post-Autologous Stem Cell<br />

Transplant in Patients with Multiple Myeloma.” Dr. Shah.<br />

Working <strong>Group</strong>s<br />

Amyloidosis Working <strong>Group</strong> update<br />

Waldenström’s Working <strong>Group</strong> update<br />

Myeloma Translational Medicine Subcommittee update<br />

SWOG • Leading Cancer Research. Together.


32 <strong>Fall</strong> <strong>2012</strong><br />

BARLOGIE-SALMON MYELOMA COMMITTEE<br />

Publications<br />

The publications below are those that have been received in<br />

published, submitted or accepted form by the <strong>Group</strong> Chair‘s Office<br />

since the Spring <strong>2012</strong> meeting agenda booklet publication list.<br />

Published/Accepted Manuscripts<br />

■■<br />

Cure models as a useful statistical tool for analyzing survival.<br />

M Othus, B Barlogie, ML LeBlanc, JJ Crowley. Clinical Cancer<br />

Research 18(14):3731-3736, <strong>2012</strong>. http://www.ncbi.nlm.nih.<br />

gov/pubmed/22675175.<br />

Submitted Manuscripts<br />

■■<br />

S0120 Clinical predictors of malignancy in monoclonal<br />

gammopathies (SWOG S0120). M Dhodapkar, R Sexton, S<br />

Waheed, S Usmani, B Nair, N Petty, JD Shaughnessy, A Hoering,<br />

J Crowley, R Orlowski, B Barlogie. Blood, submitted 8/16/12.<br />

SWOG • Leading Cancer Research. Together.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 33<br />

Barlogie-Salmon Myeloma Committee<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

CTN0702<br />

E3A06<br />

S0115<br />

S0120<br />

Arizona, U of - - - - 2<br />

Arkansas, U of - - 22 292 2<br />

Atlanta Reg CCOP - - - - 1<br />

Baylor College - - - - 15<br />

Boston MC MBCCOP - - - - 1<br />

Boston Univ Med Ctr - - 17 - -<br />

Brooke Army Med Ctr - - - 12 -<br />

Central IL CCOP - - - - 8<br />

City of Hope Med Ctr - - 1 - -<br />

Cleveland Clinic OH - - 8 2 20<br />

Colorado, U of - - - - 6<br />

Columbia River CCOP - - 1 - 3<br />

Columbia University - - - 2 6<br />

Davis, U of CA - - 7 2 1<br />

Dayton CCOP - - 1 - 6<br />

Grand Rapids CCOP - - - - 2<br />

Greenville CCOP - 6 - - -<br />

H Lee Moffitt CC 7 - - - 4<br />

Harrington CC - - - - 1<br />

Hawaii MBCCOP, U of - - - - 13<br />

Henry Ford Hosp - - 3 18 -<br />

Irvine, U of CA - - - - 6<br />

KaiserPermanenteNCAL - - - - 13<br />

Kansas City CCOP - - - 4 6<br />

Kansas, U of - - 2 15 3<br />

Kentucky, U of 1 - - - -<br />

King Faisal Spec Hos - - - - 1<br />

LSU-New Orleans CCOP - - - - 1<br />

LSU-Shreveport CCOP 4 - - - -<br />

Loyola University - - - 9 2<br />

MD Anderson - - - - 4<br />

Michigan CRC CCOP - - - - 19<br />

Michigan, U of - - - 2 -<br />

Mississippi, Univ of - - - - 2<br />

Montana CCOP - 1 - - 6<br />

New Mexico MBCCOP - - - - 7<br />

Oregon Hlth Sci Univ - - 1 - 1<br />

S0777<br />

SWOG • Leading Cancer Research. Together.


34 <strong>Fall</strong> <strong>2012</strong><br />

Barlogie-Salmon Myeloma Committee<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

CTN0702<br />

E3A06<br />

S0115<br />

S0120<br />

Providence Hosp - - - - 6<br />

Puget Sound - - 9 2 -<br />

Rochester, Univ of - - - 1 13<br />

San Antonio, U of TX 2 - 2 - 8<br />

So Calif, U of - - - 3 7<br />

Southeast CCC CCOP - - - - 34<br />

Southern Nevada CCOP - - - - 12<br />

St Louis CCOP - - - - 7<br />

St Louis University - - - 7 -<br />

Tennessee, U of - - - - 4<br />

Tulane University - - 8 - -<br />

Upstate Carolina - - - 4 8<br />

Utah, U of 1 - 4 - -<br />

Virginia Mason CCOP - - - - 1<br />

Wayne State Univ - - 6 - 12<br />

Wichita CCOP 1 - 12 - 17<br />

CALGB - - - - 22<br />

CTSU-NOS - - - - 4<br />

ECOG - - - - 158<br />

NCCTG - - - - 45<br />

NSABP - - - - 3<br />

RTOG - - - - 2<br />

Total 16 7 104 375 525<br />

Note: Some studies may not be listed because they were either closed prior to July 1, 2011 or because they are currently<br />

active but have not had any accrual through September 6, <strong>2012</strong>.<br />

S0777<br />

SWOG • Leading Cancer Research. Together.


BREAST COMMITTEE<br />

SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 35<br />

Committee Leadership<br />

Chair:<br />

Vice-Chair:<br />

Executive Officer:<br />

Statisticians:<br />

Scientific Leadership<br />

Translational Medicine:<br />

Radiation Oncology:<br />

Surgery:<br />

Pathology:<br />

Early Therapeutics:<br />

Designates<br />

Clinical Research Associates:<br />

Cancer Control Liaisons:<br />

CCOP Representative:<br />

Data Coordinators:<br />

Nurses:<br />

Patient Advocate:<br />

Pharmaceutical Science:<br />

Protocol Coordinator:<br />

Friday, October 19, <strong>2012</strong><br />

Room: Crystal B Ballroom<br />

3:00 p.m. – 7:00 p.m.<br />

Gabriel N. Hortobagyi, M.D.<br />

Julie R. Gralow, M.D.<br />

Anne F. Schott, M.D.<br />

William E. Barlow, Ph.D.<br />

Danika Lew, M.A.<br />

Daniel F. Hayes, M.D.<br />

TBD<br />

Christine Lee, M.D.<br />

Allen M. Gown, M.D.<br />

Peggy L. Porter, M.D.<br />

Francisco J. Esteva, M.D., Ph.D.<br />

Karyn N. Hart, C.C.R.P.<br />

Pamela A. Williams, R.N., M.S.N.<br />

Carol J. Fabian, M.D. (Cancer<br />

Survivorship)<br />

Dawn L. Hershman, M.D. (Health<br />

Disparities)<br />

Melanie R. Palomares, M.D.<br />

(Prevention)<br />

Helen K. Chew, M.D. (Symptom<br />

Control & QOL)<br />

David A. Decker, M.D.<br />

Jean Barce<br />

Jennie Barrett<br />

Jeri Jardine<br />

Larry Kaye<br />

Iris Syquia<br />

Dorothy Coleman, R.N., M.S.<br />

Kathy L. Czaplicki, R.N., M.S.N.<br />

Nancy Singleton<br />

Jessie Modlin, Pharm.D.<br />

Megan Hardin<br />

Time/Location<br />

Agenda<br />

3:00 – 3:05 p.m. Welcome and introductions - Gabriel N.<br />

Hortobagyi, M.D. and Julie R. Gralow, M.D.<br />

3:05 – 3:15 p.m. Publications update - Bill Barlow, Ph.D.<br />

3:15 – 3:30 p.m. How young adult research can be embedded<br />

into studies being developed in the SWOG<br />

Breast Committee - Adolescent and Young<br />

Adult Program - Leonard Sender<br />

3:30 – 3:35 p.m. Q & A<br />

3:35 – 4:00 p.m. Reports from Committee Liaisons<br />

Radiotherapy - Reshma Jagsi<br />

Surgery - J. Gralow/Christine Lee<br />

Cancer Survivorship - Carol Fabian<br />

Health Disparities - Dawn Hershman<br />

S0715<br />

Prevention - Dawn Hershman for Melanie<br />

Palomares<br />

CCOPs - David Decker<br />

4:00 – 4:35 p.m. Update of open SWOG and CTSU trials - All<br />

4:35 – 4:45 p.m. Studies in Development - All<br />

4:45 – 4:50 p.m. Request for endorsing ACOSOG Z11102 -<br />

Impact of Breast Conservation Surgery on<br />

Surgical Outcomes and Cosmesis in Patients<br />

with Multiple Ipsilateral Breast Cancers<br />

(MIBC). - Gabriel Hortobagyi for Judy<br />

Boughey<br />

Translational Medicine Sub-Committee<br />

Mini-Symposium<br />

Pharmacogenomics and Breast Cancer: A Decade Later.<br />

What Have We Learned What Should SWOG Do Next<br />

4:50 – 4:55 p.m. Introduction - Dan Hayes<br />

4:55 – 5:15 p.m. SWOG contributions to Pharmacogenomics -<br />

Christine Ambrosone<br />

5:15 – 5:20 p.m. CYP2D6 Story - Jimmy Rae<br />

5:20 – 5:30 p.m. Prospective validation trials in SWOG<br />

5:30 – 5:35 p.m. Q & A<br />

5:35 – 7:00 p.m. Translational Medicine Working <strong>Group</strong> Up<br />

dates - Daniel F. Hayes<br />

TM Studies within S0307 - Julie Gralow<br />

Active Adjuvant Studies<br />

■■<br />

S1007, “A Phase III, Randomized Clinical Trial of Standard<br />

Adjuvant Endocrine Therapy +/- Chemotherapy in Patients<br />

with 1-3 Positive Nodes, Hormone-Receptor-Positive and HER2-<br />

Negative Breast Cancer with Recurrence Score (RS) of 25 or<br />

Less.” Drs. Gonzalez-Angulo, Meric-Bernstam, Hortobagyi, Albain<br />

and Barlow. Activated: 1/15/11.<br />

■■<br />

S1207, “Phase III Randomized, Placebo-Controlled Clinical<br />

Trial Evaluating the Use of Adjuvant Endocrine Therapy +/-<br />

SWOG • Leading Cancer Research. Together.


36 <strong>Fall</strong> <strong>2012</strong><br />

BREAST COMMITTEE<br />

■■<br />

One Year of Everolimus in Patients with High-Risk, Hormone<br />

Receptor-Positive and HER2/neu Negative Breast Cancer.” Drs.<br />

Chavez-MacGregor, Gonzalez-Angulo. Planned Activation Date:<br />

11/15/12.<br />

CTSU/NSABP B-39, “A Randomized Phase III Study of<br />

Conventional Whole Breast Irradiation (WBI) Versus Partial<br />

Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast<br />

Cancer.” Dr. Pierce. Activated: 3/22/05.<br />

Treated with Single Agent Tamoxifen.” Dr. Lohrisch. Activated:<br />

10/08/10.<br />

Active Cancer Control Studies<br />

■■<br />

S0702, “A Prospective Observational Multicenter Cohort Study<br />

to Assess the Incidence of Osteonecrosis of the Jaw (ONJ)<br />

in Cancer Patients with Bone Metastases Starting Zoledronic<br />

Acid Treatment.” Drs. Van Poznak, Gralow, Schubert, and<br />

Bagramian, Lisa Hansen, R.N. Activated: 12/15/08.<br />

■■<br />

■■<br />

■■<br />

■■<br />

CTSU/NSABP B-43, “A Phase III Clinical Trial Comparing<br />

Trastuzumab Given Concurrently with Radiation Therapy and<br />

Radiation Therapy Alone for Women with HER 2-Positive Ductal<br />

Carcinoma in Situ Resected by Lumpectomy.” Dr. Chung.<br />

Activated: 11/22/08.<br />

CTSU/NSABP B-47, “A Randomized Phase III Trial of Adjuvant<br />

Therapy Comparing Chemotherapy Alone (Six Cycles of TC or<br />

Four Cycles of AC followed by Four Cycles of Weekly Paclitaxel)<br />

to Chemotherapy Plus Trastuzumab in Women with Node-<br />

Positive or High-Risk Node-Negative HER2-Normal Invasive<br />

Breast Cancer.” Dr. Albain. Activated: 1/7/11.<br />

CTSU/NSABP B-49, “A Phase III Clinical Trial Comparing<br />

the Combination of Docetaxel Plus Cyclophosphamide to<br />

Anthracycline-Based Chemotherapy Regimens for Women with<br />

Node-Positive or High-Risk Node-Negative, HER 2-Negative<br />

Breast Cancer.” Dr. Decker. Activated: 4/9/12.<br />

CTSU/NCIC MA.32, “A Phase III Randomized Trial of Metformin<br />

Versus Placebo on Recurrence and Survival in Early Stage Breast<br />

Cancer.” Dr. Hershman. Activated: 7/8/10.<br />

Active Advanced Disease Studies<br />

■■<br />

S0800, “A Randomized Phase II Trial of Weekly Nanoparticle<br />

Albumin Bound Paclitaxel (Nab-Paclitaxel) (NSC-736631)<br />

with or without Bevacizumab, either Preceded by or Followed<br />

by Q2 Week Doxorubicin (A) and Cyclophosphamide (C) plus<br />

Pegfilgrastim (PEG-G) as Neoadjuvant Therapy for Inflammatory<br />

and Locally Advanced HER-2/NEU Negative Breast Cancer.” Drs.<br />

Nahleh, Schott and Hayes. Activated: 4/1/10.<br />

■■<br />

CTSU/E2108, “A Randomized Phase III Trial of Early Local<br />

Therapy for the Intact Primary Tumor in Women with Metastatic<br />

Breast Cancer.” Dr. Christine Lee. Activated: 2/28/11.<br />

■■<br />

■■<br />

■■<br />

■■<br />

S0812, “A Randomized Double-Blind Placebo-Controlled<br />

Biomarker Modulation Study of Vitamin D in Premenopausal<br />

Women at High Risk for Breast Cancer, Phase IIB.” Drs. Crew<br />

and Hershman. Activated: 11/01/11.<br />

S0927, “A Randomized Placebo-Controlled Trial of Omega-<br />

3-Fatty Acid for the Control of Aromatase Inhibitor-Induced<br />

Musculoskeletal Pain and Stiffness in Women with Early Stage<br />

Breast Cancer, Phase III.” Drs. Hershman, Crew and Moinpour.<br />

Activated: 2/1/12.<br />

S1008, “Feasibility Study of a Physical Activity and Dietary<br />

Change Weight Loss Intervention in Breast and Colorectal Cancer<br />

Survivors Phase II.” Drs. Greenlee and Hershman. Activated:<br />

3/1/12.<br />

S1105, “Randomized Trial of Text-Messaging Intervention to<br />

Reduce Early Discontinuation of Adjuvant Aromatase Inhibitor<br />

Therapy in Women With Early Stage Breast Cancer.” Drs.<br />

Neugut, Hershman and Ramsey. Activated: 3/27/12.<br />

Closed Studies<br />

■■<br />

S0221, “Phase III Trial of Continuous Schedule AC + G Vs. Q<br />

2 Week Schedule AC, Followed by Paclitaxel Given Either Every<br />

2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant<br />

Therapy in Node-Positive or High -Risk Node-Negative Breast<br />

Cancer.” Drs. Budd and Moore. Activated: 11/1/03; Closed:<br />

1/15/12.<br />

■■<br />

S0500, “A Randomized Phase III Trial to Test the Strategy of<br />

Changing Therapy Versus Maintaining Therapy for Metastatic<br />

Breast Cancer Patients Who Have Elevated Circulating Tumor<br />

Cell Levels at First Follow-Up Assessment.” Drs. Smerage<br />

and Hayes. Activated: 10/1/06; Closed: 3/15/12 (initial<br />

registration).<br />

■■<br />

CTSU/E3108, “A Phase II Prospective Trial Correlating PFS with<br />

CYP2D6 Activity in Patients with Metastatic Breast Cancer<br />

■■<br />

S0715, “A Randomized Placebo-Controlled Trial of Acetyl<br />

L-Carnitine (ALC) for the Prevention of Taxane Induced<br />

SWOG • Leading Cancer Research. Together.


BREAST COMMITTEE<br />

SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 37<br />

Neuropathy – Phase III.” Drs. Hershman, Albain, Gotay and Lisa<br />

Hansen, R.N., M.S. Activated: 9/15/09; Closed: 2/1/11.<br />

■ ■<br />

”Omega-3 Plus Metformin for Breast Cancer Prevention.” Dr.<br />

Crew.<br />

■■<br />

■■<br />

■■<br />

■■<br />

CTSU/CALGB 40601, “Randomized Phase III Trial of Paclitaxel<br />

Combined With Trastuzumab, Lapatinib, or Both as Neoadjuvant<br />

Treatment of HER2-Positive Primary Breast Cancer.” Dr. Henry.<br />

Activated: 12/08/08; Closed: 2/29/12.<br />

CTSU/NCCTG N0733, “Randomized Phase II Trial of<br />

Capecitabine and Lapatinib With or Without IMC-A12 in Patients<br />

with HER2 Positive Breast Cancer Previously Treated with<br />

Trastuzumab and an Anthracycline and/or a Taxane.” Dr. Linden.<br />

Activated: 7/30/08; Closed: 6/8/12.<br />

CTSU/ACOSOG Z1071, “A Phase II Study Evaluating the Role<br />

of Sentinel Lymph Node Surgery and Axillary Lymph Node<br />

Dissection Following Preoperative Chemotherapy in Women<br />

with Node Positive Breast Cancer (T1-4, N1-2, M0) at Initial<br />

Diagnosis.” Dr. Byrd. Activated: 7/22/09; Closed: 5/29/12.<br />

CTSU/C40603, “Randomized Phase II 2 X 2 Factorial Trial of the<br />

Addition of Carboplatin +/- Bevacizumab to Neoadjuvant Weekly<br />

Paclitaxel Followed by Dose-Dense AC in Hormone Receptor-<br />

Poor/HER2-Negative Resectable Breast Cancer.” Dr. Somlo.<br />

Activated: 5/21/10; Closed: 8/31/12.<br />

Studies in Development<br />

■■<br />

S1202, “Phase III Study of Duloxetine for Treatment of<br />

Aromatase Inhibitor-Associated Musculoskeletal Symptoms in<br />

Women with Early Stage Breast Cancer.” Dr. Henry.<br />

New Proposals<br />

■ ■ “Randomization to Endocrine Therapy Alone Versus Endocrine<br />

Therapy Plus RAD-001 in the Neoadjuvant Setting for ER+<br />

Breast Cancers Based Upon On-Therapy Biologic Response.” Dr.<br />

Sachdev and Massarweh.<br />

■ ■<br />

■ ■<br />

■ ■<br />

“Phase III Trial of Armodafinil for Chemotherapy-Associated<br />

Fatigue and Cognitive Dysfunction.” Dr. Chew.<br />

“Phase II: T-DM1 plus Pertuzumab +/- Paclitaxel in HER<br />

2-Positive Metastatic Breast Cancer.” Dr. Elias.<br />

“PI3K-targeted Therapy in Metastatic Metaplastic/Myoepithelial<br />

Breast cancer- Who DAT” Dr. Moulder.<br />

■ ■<br />

■ ■<br />

“A Randomized Trial of High vs. Standard Dose Vitamin D and<br />

Adherence with Use of Aromatase Inhibitors in the Adjuvant<br />

Setting.” Dr. Khan.<br />

“Combined Diet, Exercise and Behavioral Modification<br />

Intervention in Breast Cancer Survivors.” Dr. Klemp.<br />

Publications<br />

The publications listed below are those that have been received in<br />

published, submitted or accepted form by the <strong>Group</strong> Chair’s Office<br />

since the Spring <strong>2012</strong> meeting agenda booklet publication list.<br />

Published/Accepted Manuscripts<br />

■■<br />

S0226 Combination anastrozole and fulvestrant in metastatic<br />

breast cancer: SWOG S0226. R Mehta, W Barlow, K Albain,<br />

T Vandenberg, S Dakhil, N Tirumali, DL Lew, DF Hayes, JR<br />

Gralow, R Livingston, GH Hortobagyi. New England Journal of<br />

Medicine 367(5):435-444, <strong>2012</strong>. http://www.ncbi.nlm.nih.gov/<br />

pubmed/22853014<br />

■■<br />

■■<br />

B-34 (NSABP) Oral clodronate for adjuvant treatment of<br />

operable breast cancer (National Surgical Adjuvant Breast and<br />

Bowel Project protocol B-34: a multicenter, placebo-controlled,<br />

randomized trial. AH Paterson, SJ Anderson, BC Lembersky,<br />

L Fehrenbacher, CI Falkson, KM King, LM Weir, AM Brufsky, S<br />

Dakhil, T Lad, L Baez-Diaz, JR Gralow, A Robidoux, EA Perez,<br />

P Zheng, CE Geyer, SM Swain, JP Costantino, EP Mamounas.<br />

Lancet Oncology,13(7):734-742, <strong>2012</strong> . http://www.ncbi.nlm.<br />

nih.gov/pubmed/22704583<br />

E2197 Prognostic value of biologic subtype and the 21-gene<br />

recurrence score relative to local recurrence after breast<br />

conservation treatment with radiation for early stage breast<br />

carcinoma: results from the Eastern Cooperative Oncology<br />

<strong>Group</strong> E2197 study. L Solin , R Gray, L Goldstein, A Recht, F<br />

Baehner, S Shak, S Badve, EA Perez, L Shulman S Martino, NE<br />

Davidson, GW Sledge, J Sparano. Breast Cancer Research and<br />

Treatment 134(2):683-692, <strong>2012</strong>. http://www.ncbi.nlm.nih.gov/<br />

pubmedterm=solin%20l%20E2197<br />

SWOG • Leading Cancer Research. Together.


38 <strong>Fall</strong> <strong>2012</strong><br />

BREAST COMMITTEE<br />

Submitted Manuscripts<br />

■■<br />

S0221 First analysis of SWOG S0221: a phase III trial<br />

comparing chemotherapy schedules in high-risk early breast<br />

cancer. GT Budd, W Barlow, HCF Moore, T Hobday, JA<br />

Stewart, C Isaacs, M Salim, J Cho, K Rinn, K Albain, H Chew,<br />

GV Burton, TD Moore, G Srkalovic, BA McGregor, LE Flaherty,<br />

RB Livingston, DL Lew, JR Gralow, GN Hortobagyi. Journal of<br />

Clinical Oncology, pending resubmission in response to reviewers’<br />

comments 8/30/12.<br />

■■<br />

■■<br />

S0715 Randomized double-blind placebo-controlled trial<br />

of acetyl-l-carnitine for the prevention of taxane induced<br />

neuropathy in women undergoing adjuvant breast cancer<br />

therapy. D Hershman, J Unger, K Crew, L Minasian, C<br />

Moinpour, L Hansen, D Lew, L Fehrenbacher, J Wade, S Wong, G<br />

Hortobagyi, F Meyskens, K Albain. Journal of Clinical Oncology,<br />

re-submitted 8/12 (also listed under Symptom Control and<br />

Quality of Life Committee).<br />

MA.27 (NCIC) Exemestane versus anastrozole in postmenopausal<br />

women with early breast cancer. PE Goss, JN Ingle, JW<br />

Chapman, MJ Ellis, GW Sledge, GT Budd, DB Johnson, M<br />

Rabaglio, KI Pritchard, C Elliott, KA Gelmon, LE Shepherd.<br />

Journal of Clinical Oncology, under review, 8/12.<br />

SWOG • Leading Cancer Research. Together.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 39<br />

Breast Committee<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

B39<br />

B43<br />

B47<br />

C40101<br />

Arizona, U of - - - 20 - - 3 - - - - - -<br />

Arkansas, U of - - 2 10 - - - - - - - - -<br />

Atlanta Reg CCOP - - 4 - - - - 13 - 1 - - 14<br />

BC Cancer Agency - - - - - - - - - - - 6 -<br />

Bay Area CCOP - - - 1 - - - - - - - - 1<br />

Beaumont CCOP - - - 2 - - - - - - - - 12<br />

Boston Univ Med Ctr - - - - - - - - - - - - -<br />

Brooke Army Med Ctr - - - 12 - - - - - - - - 3<br />

Cedars-Sinai Med Ctr - - - - - - - - - - - - -<br />

Central IL CCOP - - - 50 6 8 - - - - - - 8<br />

Cincinnati MC, U of - - - - - - - - - - - - 1<br />

City of Hope Med Ctr - - - 1 - - - 3 - - - - -<br />

Cleveland Clinic OH - - - 19 - - 1 - - - - - 9<br />

Colorado, U of - - - 3 2 - - 3 - - - - 1<br />

Columbia River CCOP - - - 2 - 1 - - - - - - 3<br />

Columbia University - - 4 43 - 6 1 - - - 2 - -<br />

Columbus CCOP - - - 93 - 3 - - 10 - - - 3<br />

Davis, U of CA 2 2 1 69 3 - 3 - 7 - 1 - 13<br />

Dayton CCOP - - - 3 - - - 3 - - - - -<br />

Galveston, U of TX - - - 37 - - - - - - - - -<br />

Grand Rapids CCOP - - - - - - - - - - - - 3<br />

Greenville CCOP - - - - - - - - - - - - -<br />

Gulf Coast MBCCOP - - - 2 - - - - - 1 - - -<br />

H Lee Moffitt CC - 2 5 4 - - - - - 1 1 - 5<br />

Harrington CC - 4 - 1 - - - - - - - - -<br />

Hawaii MBCCOP, U of - - - 5 - - - 5 - 1 - 1 1<br />

Henry Ford Hosp - - - - - - - - - - - - -<br />

INCan - - - - - - - - - - - - -<br />

Irvine, U of CA - - - - - - - - - - - - -<br />

KaiserPermanenteNCAL - - 1 - - - - - - - - - 9<br />

Kansas City CCOP - - - - - - - - - - - - 1<br />

Kansas, U of - - - 15 - 6 2 - - 1 - - -<br />

Kentucky, U of - - - - - - - - - - - - -<br />

King Faisal Spec Hos - - - - - - - - - - - - -<br />

LSU-New Orleans CCOP - - - 8 1 - - - - - - - -<br />

LSU-Shreveport - - - - - - - - - - - - 3<br />

LSU-Shreveport CCOP 1 - - - - - - - - - - - 4<br />

Lahey Clinic Med Ctr - - - - - - - - - - - - -<br />

Los Angeles, U of CA - - - - - - - - - - - - 2<br />

Loyola University 9 - 1 7 - 3 2 - - - - - 10<br />

MD Anderson - - - - - - - - - - - - 26<br />

MUSC, Hollings CC - - - 11 - - - - - - 1 - -<br />

Methodist Hospital - - - - - - - - - - - - -<br />

C40302<br />

C40503<br />

C40601<br />

C40603<br />

C70301<br />

E1105<br />

E2108<br />

E3108<br />

IBC24-02<br />

SWOG • Leading Cancer Research. Together.


40 <strong>Fall</strong> <strong>2012</strong><br />

Breast Committee<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

B39<br />

B43<br />

B47<br />

C40101<br />

Michigan CRC CCOP - - - - - - - - - - - - -<br />

Michigan, U of - - 2 25 12 - - - - - - - 14<br />

Mississippi, Univ of 3 - 1 20 - 2 - - 7 - - - -<br />

Montana CCOP - - - 6 1 - - 1 - 1 - - -<br />

National Cancer Ctr - - - - - - - - - - - - -<br />

New Mexico MBCCOP - - - - - - - - - - - - -<br />

Northwest CCOP - - - 8 - - 2 1 - - - - 1<br />

Oklahoma, Univ of - - - 8 - - - - - - - - -<br />

Oregon Hlth Sci Univ - - 1 1 - - - - - - - - -<br />

Ozarks Reg CCOP - - - 11 - 3 - - - 1 - - -<br />

Providence Hosp - - - 7 - - - - - - - - -<br />

Puget Sound - - 6 32 1 6 5 4 - 1 2 - 6<br />

Rochester, Univ of - - 3 45 - - - - - - 1 - -<br />

San Antonio, U of TX - - - 45 - - - - 1 - - - 8<br />

Santa Rosa CCOP - - - 3 - - - - - - - - 3<br />

Scott & White CCOP - - - - - - - - - - - - 1<br />

So Calif, U of - - 2 17 - - 11 4 - - - - 4<br />

Southeast CCC CCOP - - - - - - - - - 2 - - 3<br />

Southern Nevada CCOP - - - - - - - - - - - - -<br />

St Louis CCOP - - - 6 - - - - 3 - - - -<br />

St Louis University - - - - - - - - - - - - -<br />

Tennessee, U of - - - - 1 - - - - 3 - - -<br />

Tulane University - - - - - - - - - - 1 - -<br />

Upstate Carolina - - - - - - - 3 - - - - 2<br />

Utah, U of - - - 12 1 - - 2 - - - - -<br />

Virginia Mason CCOP - - - - - - 1 - - - - - 2<br />

Wayne State Univ - - 7 14 - 1 - 1 7 2 - - 6<br />

Western Reg CCOP - - - - - - - - - - - - -<br />

Wichita CCOP - - - 55 - - - 5 - - - - 5<br />

Yale University - - - - - - - - - - - - -<br />

ACOSOG - - - - - - - - - - - - -<br />

ANZ BCTG/ IBCSG - - - - - - - - - - - - -<br />

CALGB - - - - - - - - - - - - -<br />

CTSU-NOS - - - - - - - - - - - - -<br />

ECOG - - - - - - - - - - - - -<br />

FSS/ IBCSG - - - - - - - - - - - - -<br />

GOG - - - - - - - - - - - - -<br />

NCCTG - - - - - - - - - - - - -<br />

NCIC - - - - - - - - - - - - -<br />

NCIC-CTG - - - - - - - - - - - - -<br />

NSABP - - - - - - - - - - - - -<br />

RTOG - - - - - - - - - - - - -<br />

Total 15 8 40 733 28 39 31 48 35 15 9 7 187<br />

C40302<br />

C40503<br />

C40601<br />

C40603<br />

C70301<br />

E1105<br />

E2108<br />

E3108<br />

IBC24-02<br />

SWOG • Leading Cancer Research. Together.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 41<br />

JMA20<br />

Breast Committee<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

MA32<br />

N063D<br />

N0733<br />

PACCT-1<br />

Arizona, U of - 10 - - 5 38 - - - - - -<br />

Arkansas, U of - - 4 - 93 56 - 7 8 3 6 -<br />

Atlanta Reg CCOP - - 7 - 34 3 - - - - 11 3<br />

BC Cancer Agency - - - - - - - - - - - -<br />

Bay Area CCOP - 5 - - - 4 - - 1 4 1 -<br />

Beaumont CCOP - 17 - - 3 41 - 17 1 - 2 9<br />

Boston Univ Med Ctr - - - - - - - - 2 - - -<br />

Brooke Army Med Ctr - 7 2 - 29 65 1 2 1 - 1 -<br />

Cedars-Sinai Med Ctr - - - - - - - - - 2 - -<br />

Central IL CCOP - 26 10 - - 39 - 8 8 - 3 -<br />

Cincinnati MC, U of - - - - 16 8 - 1 - - 4 -<br />

City of Hope Med Ctr - - 2 - 23 36 2 2 - - 8 -<br />

Cleveland Clinic OH - 19 - - 35 61 3 15 2 5 10 -<br />

Colorado, U of - 15 4 - 16 35 - 8 7 3 2 -<br />

Columbia River CCOP - 3 - - 16 8 - 4 - - - -<br />

Columbia University - 19 3 - 70 29 2 - - - 4 6<br />

Columbus CCOP 2 - - - 2 77 1 - 3 21 6 14<br />

Davis, U of CA 3 12 10 - 71 90 2 7 5 16 5 -<br />

Dayton CCOP - - - - 2 5 1 - - 2 4 -<br />

Galveston, U of TX - - - - 6 - - 7 - - - -<br />

Grand Rapids CCOP - - - - 24 27 - 6 - - 2 -<br />

Greenville CCOP - - - - 26 22 1 25 - - 1 -<br />

Gulf Coast MBCCOP - - 1 - 11 5 - - - 2 2 -<br />

H Lee Moffitt CC - 9 - - 68 - - 2 - - - -<br />

Harrington CC - - - - - - - - - - 1 -<br />

Hawaii MBCCOP, U of - 9 7 - 155 107 - 13 - 2 3 -<br />

Henry Ford Hosp - - - - 14 23 1 24 - 2 - -<br />

INCan - - - - - - - - - - 12 -<br />

Irvine, U of CA - - - - 51 6 - 1 - - 6 -<br />

KaiserPermanenteNCAL - 144 - 2 37 - - - - - 21 -<br />

Kansas City CCOP - 10 2 - 29 30 - - - - 2 6<br />

Kansas, U of - - 8 - 24 24 1 4 - - 2 -<br />

Kentucky, U of - - - - - - - - - - 8 -<br />

King Faisal Spec Hos - - - - - - 3 - - - - -<br />

LSU-New Orleans CCOP - 2 1 - - 16 - - - - - -<br />

LSU-Shreveport - - - - 12 66 - - - - - -<br />

LSU-Shreveport CCOP - - - - 53 64 - - - - - -<br />

Lahey Clinic Med Ctr - 2 - - - - - - - - 2 -<br />

Los Angeles, U of CA - - - - - - - - - - - -<br />

Loyola University - 5 7 - 33 102 2 - 2 - 8 1<br />

MD Anderson - - - - 96 - 2 1 - - 44 -<br />

MUSC, Hollings CC - 7 3 - 11 - - - - - 4 6<br />

Methodist Hospital - - - - - - - - - - 1 -<br />

S0221<br />

S0230<br />

S0500<br />

S0622<br />

S0800<br />

S1007<br />

Z1071<br />

SWOG • Leading Cancer Research. Together.


42 <strong>Fall</strong> <strong>2012</strong><br />

JMA20<br />

SWOG • Leading Cancer Research. Together.<br />

Breast Committee<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

MA32<br />

N063D<br />

N0733<br />

PACCT-1<br />

Michigan CRC CCOP - - - - - 92 - 39 9 13 12 -<br />

Michigan, U of - 24 - - 3 37 3 28 13 3 8 3<br />

Mississippi, Univ of - 10 3 - 66 12 - 14 1 3 1 -<br />

Montana CCOP - - - - 13 67 2 7 6 2 1 -<br />

National Cancer Ctr - - - - - - - - - - 10 -<br />

New Mexico MBCCOP - 9 - - - 32 - 5 2 14 4 -<br />

Northwest CCOP - 22 4 1 23 49 - 3 1 7 6 -<br />

Oklahoma, Univ of - - - - - - - - - - - -<br />

Oregon Hlth Sci Univ - 11 - - 31 3 3 1 - - - -<br />

Ozarks Reg CCOP - - - - 7 44 2 4 - 8 3 -<br />

Providence Hosp - - 3 - 4 18 - 9 - 6 - -<br />

Puget Sound - 10 3 3 73 101 2 10 - 1 5 3<br />

Rochester, Univ of - - 1 - 49 10 1 - 3 - - -<br />

San Antonio, U of TX 1 - 4 - 59 52 - 20 1 7 2 -<br />

Santa Rosa CCOP - - - - 6 - - - - - - -<br />

Scott & White CCOP - - - - - 27 - 8 - - - -<br />

So Calif, U of - 5 - - 68 47 6 10 - 17 7 5<br />

Southeast CCC CCOP 1 4 1 1 25 43 2 15 2 3 9 -<br />

Southern Nevada CCOP - - - - - - - - 1 - 1 -<br />

St Louis CCOP - 10 1 - 12 7 - - - - 2 -<br />

St Louis University 1 - - - 12 - - - - - 1 -<br />

Tennessee, U of - 3 3 - 59 13 2 3 - - 2 -<br />

Tulane University - - 3 - - 3 - - - - 3 -<br />

Upstate Carolina - 4 - - 6 1 - - 5 13 - -<br />

Utah, U of - 22 8 - 61 42 - 5 - - 3 -<br />

Virginia Mason CCOP - 1 - - 2 20 - 9 1 - 10 -<br />

Wayne State Univ - 7 14 - 66 76 - 9 - 6 7 2<br />

Western Reg CCOP - - - - 2 6 - - - - - -<br />

Wichita CCOP - 10 - - - 16 8 4 - - 12 9<br />

Yale University - - - - - - - - - - 2 -<br />

ACOSOG - - - - - 20 - 13 - 1 13 -<br />

ANZ BCTG/ IBCSG - - - - - - 58 - - - - -<br />

CALGB - - - - - 324 14 57 - 6 75 -<br />

CTSU-NOS - - - - - 43 - - - - - -<br />

ECOG - - - - - 419 86 88 - 9 92 -<br />

FSS/ IBCSG - - - - - - 46 - - - - -<br />

GOG - - - - - 1 - - - - 3 -<br />

NCCTG - - - - - 431 - 62 - 10 29 -<br />

NCIC - - - - - - - - - - 10 -<br />

NCIC-CTG - - - - - 96 - - - - - -<br />

NSABP - - - - - 32 - 45 - 1 48 -<br />

RTOG - - - - - 23 - 2 - - 1 -<br />

Total 8 473 119 7 1,712 3,294 257 624 85 192 568 67<br />

S0221<br />

S0230<br />

S0500<br />

S0622<br />

S0800<br />

S1007<br />

Note: Some studies may not be listed because they were either closed prior to July 1, 2011 or<br />

because they are currently active but have not had any accrual through September 6, <strong>2012</strong>.<br />

Z1071


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 43<br />

CANCER CONTROL & PREVENTION COMMITTEES<br />

Committee Leadership<br />

Assoc. Chair for Cancer<br />

Control & Prevention:<br />

Frank L. Meyskens, Jr., M.D.<br />

CC&P Executive Council Co-Chair: Powel Brown, M.D., Ph.D.<br />

Statisticians:<br />

Garnet Anderson, Ph.D.<br />

William E. Barlow, Ph.D.<br />

Joseph M. Unger, M.S.<br />

Danika Lew, M.A.<br />

Kathryn B. Arnold, M.S.<br />

Scientific Leadership<br />

CCOP Representative:<br />

Mark A. O’Rourke, M.D.<br />

Radiation Therapy Committee: Louis “Sandy” Constine, M.D.<br />

Surgery Committee:<br />

Robert S. Krouse, M.D., F.A.C.S.<br />

Translational Medicine:<br />

Liaisons:<br />

Breast Cancer Committee:<br />

James (Jimmy) Rae, Ph.D.<br />

Carol J. Fabian, M.D.<br />

(Survivorship)<br />

Helen Chew, M.D. (Symptom<br />

Control & QOL)<br />

Dawn Hershman, M.D., M.S.<br />

(Outcomes)<br />

Melanie Palomares, M.D.<br />

(Prevention)<br />

Gastrointestinal Committee Colon: Jason, Zell, D.O.<br />

Genitourinary Committee: Peter J. Van Veldhuizen, Jr., M.D.<br />

International Liaison:<br />

Kathy S. Albain, M.D.<br />

Lung Committee:<br />

Gary E. Goodman, M.D.<br />

Lymphoma Committee:<br />

John W. Hayslip, M.D.<br />

Melanoma Committee:<br />

TBD<br />

Designates<br />

Clinical Research Associates:<br />

Nursing Committee:<br />

Pharmaceutical Science:<br />

Statistical Center Support:<br />

Patient Advocates:<br />

Connie Szczepanek, R.N., B.S.N.<br />

Susan Majeski, C.C.R.P.<br />

Joyce N. Tull, R.N., B.S.N.<br />

Micheal F. Stephens, C.C.R.A.<br />

Lisa Hansen, R.N., M.S.<br />

Siu-Fun Wong, Pharm.D.<br />

Stephanie Edwards<br />

Jeri Jardine<br />

Jennie Barrett<br />

Monica Yee<br />

Dona Marrah<br />

Diane Liggett<br />

Roxanne Topacio<br />

Amy Johnson<br />

Daniel M. Moore, Jr., J.D.<br />

Anna Gottlieb<br />

Protocol Coordinator -<br />

(Outcomes and Comparative<br />

Effectiveness, Prevention, and<br />

Molecular Epidemiology):<br />

Protocol Coordinator -<br />

(Cancer Survivorship; Symptom<br />

Control and Quality of Life):<br />

Patricia O’Kane<br />

Kimberly Kaberle<br />

Cancer Control and Prevention Executive Council<br />

(Committee Members Only)<br />

Thursday, October 18, <strong>2012</strong><br />

Room: Truffles<br />

8:00 a.m. – 10:00 a.m.<br />

Time/Location<br />

Agenda<br />

8:00 – 8:15 a.m. Associate Chair Report - F. Meyskens, Jr.<br />

8:15 – 8:25 a.m. Questions<br />

8:25 – 8:35 a.m. SWOG and AYA - L. Sender<br />

8:35 – 8:40 a.m. Questions<br />

8:40 – 8:50 a.m. Statistical Update - G. Anderson & B. Barlow<br />

8:50 – 9:00 a.m. Questions<br />

COMMITTEE REPORTS<br />

9:00 – 9:10 a.m. Prevention Committee<br />

P. Brown/G. Goodman<br />

9:10 – 9:20 a.m. Cancer Survivorship Committee<br />

C. Fabian/R. Krouse<br />

9:20 – 9:30 a.m. Symptom Control and QOL Committee<br />

C. Moinpour/J. Wade<br />

9:30 – 9:40 a.m. Outcomes and Comparative Effectiveness<br />

Committee - D. Hershman/S. Ramsey<br />

9:40 – 9:50 a.m. Molecular Epidemiology Committee<br />

R. Santella<br />

9:50 – 10:00 a.m. Pharmacy Update - SF. Wong<br />

SWOG • Leading Cancer Research. Together.


44 <strong>Fall</strong> <strong>2012</strong><br />

CANCER CONTROL & PREVENTION COMMITTEES<br />

Harry E. Hynes CCOP Symposium (Joint Session)<br />

Friday, October 19, <strong>2012</strong><br />

Room: Regency A<br />

10:00 a.m. – 12:00 p.m.<br />

Time/Location<br />

Agenda<br />

10:00 – 10:05 a.m. WELCOME - Mark O’Rourke, M.D.<br />

10:05 – 10:15 a.m. Associate Chair Report<br />

Frank L. Meyskens, Jr., M.D.<br />

10:15 – 10:45 a.m. What is integrative oncology<br />

Heather Greenlee, N.D., Ph.D.<br />

10:45 – 10:50 a.m. Questions<br />

10:50 – 11:10 a.m. Comparative Effectiveness Research:<br />

What is it all about<br />

Scott Ramsey, M.D., Ph.D.<br />

11:10 – 11:15 a.m. Questions<br />

11:15 – 11:40 a.m. CC&P Committee Updates to<br />

CCOPs<br />

11:40 a.m. – 12:00 p.m. Open Forum for CCOP Investigators<br />

SWOG • Leading Cancer Research. Together.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 45<br />

CANCER SURVIVORSHIP COMMITTEE<br />

Cancer Survivorship Committee Co-Chairs:<br />

Carol J. Fabian, M.D.<br />

Robert S. Krouse, M.D.<br />

Friday, October 19, <strong>2012</strong><br />

Room: Comiskey<br />

7: 15 a.m. – 9:45 a.m.<br />

Introductions and Updates<br />

7:15 - 7:20 a.m. Welcome<br />

Time/Location<br />

Agenda<br />

Presentations:<br />

7:20 - 7:35 a.m. Dr. Leonard Sender: How young adult research<br />

can be embedded into studies being developed in<br />

the SWOG Cancer Survivorship Committee<br />

7:35 - 7:50 a.m. Dr. Lisa Sparks: Use of Social Media to recruit<br />

into SWOG studies<br />

7:50 - 8:00 a.m. Dr. Monika Leja: Left ventricular strain and<br />

serum troponin to predict cardiac toxicity from<br />

trastuzumab and anthracyclines.<br />

■■<br />

■■<br />

■■<br />

■■<br />

6/11/11. Cancer Control Credits: 0.2 ($400) at pre-registration;<br />

0.8($1,600) at enrollment. Accrual Update<br />

S1008, “Pilot and Feasibility Study of a Physical Activity<br />

and Dietary Change Weight Loss Intervention in Breast and<br />

Colorectal Cancer Patients.” Dr. Greenlee. Activated: 3/1/12.<br />

Cancer Control Credits: 1.0 ($2,000). Update on accrual – Need<br />

for Eligibility Amendment<br />

Moderate Dose Vitamin D vs Placebo to Prevent AI Associated<br />

Musculoskeletal Symptoms. Dr. Khan. Study Submitted to<br />

Triage. Update Schema. (Secondary Committee Symptom<br />

Control /QOL).<br />

Change in Impaired Cardiopulmonary Fitness with Graded<br />

Intensity Exercise vs Usual Care in Overweight and Obese Breast<br />

Cancer Survivors. Drs. Klemp, Porter, and Floyd. (Secondary<br />

Committee Breast). Update on Schema and Time Table to<br />

Triage.<br />

Proposed Intergroup A Randomized Controlled Trial of the Impact<br />

of a Telephone-Based Weight Loss Intervention Plus Health<br />

Education Materials versus Health Education Materials Only<br />

upon Invasive Disease Free Survival in Overweight and Obese<br />

Women with Early Stage Breast Cancer. Dr. Korde. (Secondary<br />

Committee Breast ) Update Progress.<br />

8:00 - 8:10 a.m. Discussion<br />

New Concepts Proposed (at April <strong>Meeting</strong>) - 10 minutes each<br />

■■<br />

Effect of Everolimus vs Placebo on Intermediate Markers of<br />

Health and Lifespan in Renal Cell Carcinoma Survivors. Drs.<br />

Nicolas Musi and Peter Van Veldhuizen (Secondary Committee<br />

Genitourinary). Update Concept and Probable Funding Source.<br />

■■<br />

■■<br />

Long term effects of Urinary Diversion in Bladder Cancer<br />

Survivors. Dr. Scott Gilbert (Secondary Committee Genitourinary)<br />

Update Concept.<br />

Bowel obstruction from Metastatic Cancer: Dr. Robert Krouse.<br />

Update Concept.<br />

Newly Activated Studies and Update of Concepts Previously<br />

Proposed - 5 minutes each<br />

■■<br />

The Men’s Eating and Living (MEAL) Study: A Randomized<br />

Trial of Diet to Alter Disease Progression in Prostate Cancer<br />

Patients on Active Surveillance. Dr. Van Veldhuizen. Activated:<br />

Special Projects/ Presentations - 10 minutes each<br />

■■<br />

Rick Bangs: Advocate Update.<br />

■■<br />

■■<br />

Update on SWOG Survivorship Care Plan : Klemp, Lackey, Cook,<br />

Crowley, Anderson ( Secondary Committee is Breast) Present<br />

Design and Source of Support.<br />

International Survivorship Update: Report from the meeting. Dr.<br />

Kathy Albain.<br />

Other Business<br />

Active Studies<br />

■■<br />

Ancillary to S0221 (R01), Antioxidant and CAM Use and<br />

Survival. Drs. Ambrosone and Albain.<br />

■■<br />

S0702, “A Prospective Observational Multicenter Cohort Study<br />

to Assess the Incidence of Osteonecrosis of the Jaw (ONJ) in<br />

Cancer Patients with Bone Metastasis Starting Zoledronic Acid<br />

Treatment.” Drs. Van Poznak and Gralow. Activated: 12/15/08.<br />

(Primary Committee Symptom Control).<br />

SWOG • Leading Cancer Research. Together.


46 <strong>Fall</strong> <strong>2012</strong><br />

CANCER SURVIVORSHIP COMMITTEE<br />

■■<br />

■■<br />

S1008, “Pilot and Feasibility Study of a Physical Activity<br />

and Dietary Change Weight Loss Intervention in Breast and<br />

Colorectal Cancer Patients.” Dr. Greenlee. Activated: 3/1/12.<br />

CTSU/C70807, “The Men’s Eating and Living (MEAL) Study: A<br />

Randomized Trial of Diet to Alter Disease Progression in Prostate<br />

Cancer Patients on Active Surveillance.” Dr. Parsons. Activated:<br />

6/1/11. (Primary Committee Genitourinary)<br />

Closed Studies<br />

■■<br />

S0230, “Phase III Trial of LHRH Analog Administration<br />

During Chemotherapy to Reduce Ovarian Failure Following<br />

Chemotherapy in Early Stage, Hormone-Receptor Negative<br />

Breast Cancer.” Drs. Moore, Albain, and Martino. Activated:<br />

10/1/03; Closed: 6/1/11.<br />

■■<br />

S0715, “Randomized Placebo-Controlled Trial of Acetyl<br />

L-Carnitine For The Prevention Of Taxane-Induced Neuropathy.”<br />

Drs. Hershman, Albain, Gotay and Lisa Hansen, R.N., M.S. (Coassignment<br />

to Symptom Control/OOL Committee). Activated:<br />

9/15/09; Closed: 2/1/11.<br />

9:45 Adjourn<br />

Publications<br />

The publications listed below are those that have been received in<br />

published, submitted or accepted form by the <strong>Group</strong> Chair’s Office<br />

since the Spring <strong>2012</strong> meeting agenda booklet publication list.<br />

Published/Accepted Manuscripts<br />

■■<br />

S0316 A prospective analysis of the influence of older age on<br />

physician decision-making when considering enrollment to breast<br />

cancer clinical trials (SWOG S0316). SH Javid, JM Unger, JR<br />

Gralow, CM Moinpour, AJ Wozniak, JW Goodwin, PN Lara, PA<br />

Williams, LF Hutchins, CC Gotay, KS Albain. The Oncologist<br />

<strong>2012</strong> June 20 [Epub ahead of print]. http://www.ncbi.nlm.nih.<br />

gov/pubmed/22723506<br />

Submitted Manuscripts<br />

No publication information for this cycle.<br />

SWOG • Leading Cancer Research. Together.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 47<br />

MOLECULAR EPIDEMIOLOGY COMMITTEE<br />

Molecular Epidemiology Committee Co-Chairs:<br />

Regina M. Santella, Ph.D.<br />

No publication information for this cycle.<br />

Thursday, October 18, <strong>2012</strong><br />

Room: Regency C<br />

5:30 – 7:30 p.m.<br />

Time/Location<br />

Agenda<br />

Presentation<br />

Supplement Use During an Intergroup Clinical Trial for Breast Cancer<br />

(S0221) - Gary Zirpoli, MA Roswell Park Cancer Institute and the<br />

University at Buffalo<br />

Discussion<br />

Closed Studies<br />

S0424, “Molecular Epidemiology Case-Series Study of Non-Small<br />

Cell Lung Cancer in Smoking and Non-Smoking Women and Men.”<br />

Drs. Ambrosone, Santella, Albain, Gumerlock and Reid. Activated:<br />

10/1/05 Closed: 3/15/11. (Santella or Redman report)<br />

Active Studies<br />

■■<br />

S8897 papers – Song Yao<br />

■■<br />

■■<br />

■■<br />

■■<br />

■■<br />

■■<br />

S8897 Grant to examine SNPs in microRNAs in relation to<br />

toxicity and survival. Dr. Yao.<br />

Update on collaboration with Margaret Briehl, Lisa Rimsza<br />

(Translational Medicine) on Variants in Oxidative Stress<br />

Pathways and Lymphoma Outcomes (funded by Hope<br />

Foundation). Dr. Yao.<br />

S0221 Antioxidant study, status of papers (Ambrosone).<br />

S0221 Grant to perform a genome wide scan in relation to<br />

toxicities. Dr. Ambrosone.<br />

PCPT P01Status of studies/papers.<br />

SELECT and PCPT biorepository use requests.<br />

New Business<br />

■■<br />

Examine genetic variants in relation to cisplatin-related toxicities<br />

among patients with colorectal cancer. Drs. Zell and Ambrosone.<br />

SWOG • Leading Cancer Research. Together.


48 <strong>Fall</strong> <strong>2012</strong><br />

OUTCOMES AND COMPARATIVE EFFECTIVENESS<br />

COMMITTEE<br />

Outcomes and Comparative Effectiveness Committee Co-Chairs:<br />

Dawn L. Hershman, M.D., M.S.<br />

Scott D. Ramsey, M.D., Ph.D.<br />

Thursday, October 18, <strong>2012</strong><br />

Room: Regency C<br />

12:45 p.m. – 2:45 p.m.<br />

Time/Location<br />

Agenda<br />

■ ■<br />

■■<br />

■■<br />

“A Sero-Epidemiology Survey and Cost-Effectiveness Study of<br />

Screening for HIV, Hepatitis B and Hepatitis C Among Newly<br />

Diagnosed Cancer Patients Among SWOG Affiliated Oncology<br />

Clinics.” Dr. Ramsey.<br />

Grants Submitted<br />

Aligning Genomic Testing with Patient and Physician Preferences<br />

in NSCLC (AGENT-P). Dr. Carlson.<br />

Publications<br />

Presentations<br />

“Adaptive Trial Design” - Bryan Luce, Ph.D., M.B.A., Director of<br />

United Biosource Corporation.<br />

”The Generalizability of Phase III Cancer Clinical Trial Standard Arm<br />

Treatment Outcomes” - Joseph M. Unger, M.S.<br />

Active Studies<br />

■■<br />

S1007, “Update on Quality of Life and Economic Analysis Substudy<br />

of Breast protocol S1007.” Bill Barlow, Ph.D.<br />

■■<br />

S1105, “Randomized Controlled Trial of a Behavioral<br />

Intervention to Improve Adherence to Adjuvant Aromatase<br />

Inhibitor Therapy in Women with Early Stage Breast Cancer.”<br />

Drs. Neugut and Hershman. Activated: 3/27/12.<br />

Closed Studies<br />

■■<br />

NexCura Barriers Survey<br />

Ongoing Database projects<br />

■■<br />

Toxicity and survival analysis by gender in Southwest Oncology<br />

<strong>Group</strong> Trials. Dr. Albain, Joseph M. Unger, M.S. and Carolyn<br />

Gotay, Ph.D. Endpoint/Demographic Factor: Gender – Update on<br />

manuscript status.<br />

Disease type: Multiple<br />

The publications listed below are those that have been received in<br />

published, submitted or accepted form by the <strong>Group</strong> Chair’s Office<br />

since the Spring <strong>2012</strong> meeting agenda booklet publication list.<br />

Published/Accepted Manuscripts<br />

■■<br />

The automatic clinical trial: leveraging the electronic medical<br />

record in multisite cancer clinical trials. K Goodman, J<br />

Krueger, J Crowley. Current Oncology Reports <strong>2012</strong> Aug<br />

21 [Epub ahead of print]. http://www.ncbi.nlm.nih.gov/<br />

pubmedterm=goodman%20k%20automatic<br />

■■<br />

When progressive disease does not mean treatment failure:<br />

reconsidering criteria for progression. G Oxnard, M Morris, S<br />

Hodi, L Baker, A Venook, L Schwartz. Journal of the National<br />

Cancer Institute <strong>2012</strong> Aug 27 [Epub ahead of print]. http://www.<br />

ncbi.nlm.nih.gov/pubmed/22927506<br />

Submitted Manuscripts<br />

■■<br />

Patient income level and cancer clinical trial participation. J<br />

Unger, D Hershman, K Albain, C Moinpour, J Petersen, K Burg, J<br />

Crowley. Journal of Clinical Oncology, resubmitted 8/31/12.<br />

■■<br />

■■<br />

Medicare claims data as a core resource for comparative<br />

effectiveness studies. Dr. Hershman, Joseph M. Unger, M.S.<br />

Disease type: Multiple<br />

Proposed Letter of Intent: Pending CTEP Review<br />

SWOG • Leading Cancer Research. Together.


PREVENTION COMMITTEE<br />

SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 49<br />

Prevention Committee Co-Chairs:<br />

Powel Brown, M.D., Ph.D.<br />

Gary E. Goodman, M.D.<br />

Thursday, October 18, <strong>2012</strong><br />

Room: Regency C<br />

3:15 p.m. – 5:15 p.m.<br />

Time/Location<br />

Closed Studies<br />

■■<br />

S0000, “Selenium and Vitamin E Cancer Prevention Trial<br />

(SELECT).” Drs. Klein, Lippman, Thompson and Lucia.<br />

Activated: 7/25/01; Closed: 6/24/04.<br />

■■<br />

S0000A, “Prevention of Alzheimer’s Disease with Vitamin E and<br />

Selenium (PREADVISE), Phase III Ancillary to S0000 – SELECT.”<br />

Drs. Markesbery and Schmitt. Activated: 5/17/02; Closed:<br />

9/30/09.<br />

Introduction<br />

Agenda<br />

■■<br />

S0000C, “Prevention of Lung Function Decline with Vitamin E<br />

and Selenium – Respiratory Ancillary Study (RAS) to SELECT.”<br />

Drs. Cassano and Kristal. Activated: 6/4/04; Closed: 5/1/07.<br />

Presentation: “How Young Adult Research Can Be Embedded Into<br />

Studies Being Developed in the SWOG Prevention Committee.” Dr.<br />

Leonard Sender, Division Chief, Pediatric Oncology, University of<br />

California, Irvine.<br />

■■<br />

E5597, “Phase III Chemoprevention Trial of Selenium<br />

Supplementation in Persons with Resected Stage I Non-Small<br />

Cell Lung Cancer.” Dr. Kucuk. Activated: 12/1/00; Closed:<br />

11/5/09.<br />

Panel Discussion: Cancer prevention studies in the adolescent and<br />

young adult population.<br />

Active Studies<br />

■■<br />

S0812, “A Randomized Double-Blind Placebo-Controlled<br />

Biomarker Modulation Study of Vitamin D in Premenopausal<br />

Women at High-Risk For Breast Cancer, Phase IIB.” Dr. Crew.<br />

Activated: 11/1/11.<br />

■■<br />

■■<br />

■■<br />

S00002, “Centralized Follow-up to Selenium and Vitamin<br />

E Cancer Prevention Trial (SELECT).“ Drs. Klein, Lippman,<br />

Thompson and Lucia. Activated: 11/01/09.<br />

S0000B, “Prevention of Cataract and Age-Related Macular<br />

Degeneration with Vitamin E and Selenium – SELECT Eye<br />

Endpoints (SEE) Phase III Ancillary to S0000 – SELECT.” Drs.<br />

Christen, Glynn and Gaziano. Activated: 7/1/04.<br />

S0000D, “A Study of the Effect of Vitamin E and/or Selenium on<br />

Adenomatous Colorectal Polyps (ACP) in Participants Enrolled<br />

in SELECT, Phase III Ancillary to S0000-SELECT.” Drs. Lance,<br />

Alberts, Battacharyya, Green, and Martinez. Activated: 6/3/08.<br />

■■<br />

S0701, “A Phase III Randomized Trial of Three Antibiotic<br />

Regimens to Eradicate Helicbacter Pylori.” Dr. Greenberg.<br />

Activated: 6/16/09; Closed: 6/30/10.<br />

Proposed Studies (on website)<br />

■■<br />

S0820, “A Double-Blind Placebo-Controlled Trial of Eflornithine<br />

and Sulindac to Prevent Recurrence of High Risk Adenomas and<br />

Second Primary Colorectal Cancers in Patients With Stage 0-III<br />

Colon Cancer, Phase III.” Drs. Zell, Brown, Lance, Krouse and<br />

Lipkin. Posted for IRB review: 4/15/11.<br />

New Business<br />

1. Committee re-organization of Molecular Epidemiology and<br />

Prevention Committees (P. Brown, F. Meyskens)<br />

2. Discussion of future prostate cancer prevention trials (P. Brown,<br />

G. Goodman, I. Thompson)<br />

Publications<br />

The publications listed below are those that have been received in<br />

published, submitted or accepted form by the <strong>Group</strong> Chair’s Office since<br />

the Spring <strong>2012</strong> meeting agenda booklet publication list.<br />

■■<br />

S1119, “Gastric Cancer and Helicobacter Pylori Infection in<br />

Lima, Peru: The Role of Water Contamination.” Dr. Valdivieso.<br />

Activated: 12/2/11.<br />

Published/Accepted Manuscripts<br />

■■<br />

S0000A Age expanded normative data for the Ruff 2 & 7<br />

Selective Attention test: evaluating cognition in older males. A<br />

Caban-Holt, E Abner, RJ Kryscio, J Crowley, FA Schmitt. The<br />

Clinical Neuropsychologist 26(5):751-768, <strong>2012</strong>. http://www.<br />

ncbi.nlm.nih.gov/pubmed/22651854<br />

SWOG • Leading Cancer Research. Together.


50 <strong>Fall</strong> <strong>2012</strong><br />

PREVENTION COMMITTEE<br />

■■<br />

S0000A A randomized controlled Alzheimer’s disease prevention<br />

trial’s evolution into an exposure trial. RJ Kryscio, EL Abner, FA<br />

Schmitt, PJ Goodman, M Mendiondo, A Caban-Holt, BC Dennis,<br />

EA Klein, JJ Crowley. Journal of Nutrition, Health and Aging,<br />

accepted 4/4/12.<br />

■■<br />

S9217 Projecting prostate cancer mortality in the PCPT and<br />

REDUCE chemoprevention trials. PF Pinsky, A Black, R Grubb,<br />

ED Crawford, G Andriole, I Thompson, H Parnes. Cancer <strong>2012</strong><br />

Aug 14 [Epub ahead of print] http://www.ncbi.nlm.nih.gov/<br />

pubmed/22893105<br />

■■<br />

■■<br />

■■<br />

■■<br />

■■<br />

■■<br />

S0000 Evaluation of selenium supplementation on the prevention<br />

of bladder cancer in SWOG-coordinated SELECT. Y Lotan,<br />

P Goodman, R Youssef, R Svatek, S Shariat, C Tangen, IM<br />

Thompson, E Klein. Journal of Urology 187(6):2005-2010,<br />

<strong>2012</strong>. http://www.ncbi.nlm.nih.gov/pubmedterm=lotan%20<br />

y%20selenium<br />

S0000 Moving a randomized clinical trial into an observational<br />

cohort. PJ Goodman, JA Hartline, CM Tangen, JJ Crowley, LM<br />

Minasian, EA Klein, ED Cook, K Anderson, M Yee, FL Meyskens,<br />

LH Baker. Clinical Trials, accepted 8/13/12.<br />

S9217 Associations of serum sex steroid hormones and<br />

5a-androstane-3a,17ß-diol glucuronide concentrations with<br />

prostate cancer risk among men treated with finasteride. AR<br />

Kristal, CA Till, CM Tangen, PJ Goodman, ML Neuhouser, FZ<br />

Stanczyk, LW Chu, SK Patel, IM Thomspon, J Reichardt, AM<br />

Hoque, EA Platz, WD Figg, A van Bokhoven, SM Lippman, AW<br />

Hsing. Cancer Epidemiology Biomarkers and Prevention <strong>2012</strong><br />

Aug 9 [Epub ahead of print]. http://www.ncbi.nlm.nih.gov/<br />

pubmed/22879203<br />

S9217 Prospective study of cytomegalovirus serostatus and<br />

prostate cancer risk in the prostate cancer prevention trial. S<br />

Sutcliffe, C Till, CA Gaydos, FJ Jenkins, P Goodman, A Hoque,<br />

AW Hsing, IM Thompson, JM Zenilman, WG Nelson, AM<br />

DeMarzo, EA Platz. Cancer Causes and Control, 23(9):1511-<br />

1518, <strong>2012</strong>. http://www.ncbi.nlm.nih.gov/pubmed/22810146<br />

S9217 Indications for and use of nonsteroidal anti-inflammatory<br />

drugs and the risk of incident, symptomatic benign prostatic<br />

hyperplasia: results from the prostate cancer prevention trial.<br />

JM Schenk, GS Calip, CM Tangen, P Goodman, JK Parsons,<br />

IM Thompson, Kristal AR. American Journal of Epidemiology<br />

176(2):156-1663, <strong>2012</strong>. http://www.ncbi.nlm.nih.gov/<br />

pubmed/22759721<br />

S9217 Finasteride reduces the risk of incident symptomatic<br />

benign prostatic hyperplasia. JK Parsons, JM Schenk, KB<br />

Arnold, K Messer, C Till, IM Thompson, A Kristal. European<br />

Urology, 61(6):1263-1270, <strong>2012</strong>. http://www.ncbi.nlm.nih.gov/<br />

pubmed/22459892<br />

SWOG • Leading Cancer Research. Together.<br />

Submitted Manuscripts<br />

■■<br />

S0701 Risk of recurrence and probability of successful<br />

eradication of Helicobacter pylori: one-year results of a<br />

randomized trial in seven Latin American sites (SWOG S0701).<br />

DR Morgan, J Torres, R Sexton, R Herrero, E Salazar-Martinez,<br />

ER Greenberg, LE Bravo, RL Dominguez, C Ferreccio, E Lazcano-<br />

Ponce, MM Meza-Montenegro, EM Pena, R Pena, P Correa, ME<br />

Martinez, WD Chey, M Valdivieso, GL Anderson, GE Goodman,<br />

JJ Crowley, LH Baker. Journal of the American Medical<br />

Association, submitted 8/21/12.<br />

■■<br />

S0701 Epidemiology of Helicobacter pylori infection in six Latin<br />

American countries (SWOG trial S0701). C Porras, J Nodora,<br />

R Sexton, R Ferreccio, S Jimenez, RL Dominguez, MP Cook,<br />

GL Anderson, DR Morgan, LH Baker, ER Greenberg, H Herrero.<br />

Cancer Causes and Control, submitted 8/22/12.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 51<br />

SYMPTOM CONTROL & QUALITY OF LIFE COMMITTEE<br />

Symptom Control and QOL Committee Co-Chairs:<br />

James L. Wade, III, M.D.<br />

Carol M. Moinpour, Ph.D.<br />

Thursday, October 18, <strong>2012</strong><br />

Room: Regency C<br />

10:15 a.m. - 12:15 p.m.<br />

Time/Location<br />

Agenda<br />

Introductions and Presentations<br />

Active Studies<br />

■■<br />

S0702, “A Prospective Observational Multicenter Cohort Study<br />

to Assess the Incidence of Osteonecrosis of the Jaw (ONJ) in<br />

Cancer Patients with Bone Metastasis Starting Zoledronic Acid<br />

Treatment.” Drs. Gralow and Van Poznak. Activated: 12/15/08.<br />

■■<br />

■■<br />

■■<br />

S0927, “Randomized Placebo-Controlled Trial of Omega-3-<br />

Fatty Acid for the Control of Aromatase Inhibitor-Induced<br />

Musculoskeletal Pain in Women with Early Stage Breast Cancer,<br />

Phase III.” Drs. Hershman and Crew. Activated: 2/1/12.<br />

S1013, “A Phase II Prospective Study of Epidermal Growth<br />

Factor Receptor (HER-1/EGFR) Inhibitor-Induced Dermatologic<br />

Toxicity: Validation of the Functional Assessment of Cancer<br />

Therapy – EGFRI 18 (FACT-EGFRI 18) Questionnaire for EGFRIinduced<br />

Skin Toxicities.” Dr. Wong. Activated: 11/15/11.<br />

S1200, “Randomized Blinded Sham- and Waitlist-Controlled<br />

Trial of Acupuncture for Joint Symptoms Related to Aromatase<br />

Inhibitors in Women with Early Stage Breast Cancer.” Drs.<br />

Hershman and Crew. Activated: 4/1/12.<br />

Closed Studies<br />

■■<br />

S0715, “Randomized Placebo-Controlled Trial of Acetyl<br />

L-Carnitine for the Prevention of Taxane-Induced Neuropathy.”<br />

Drs. Hershman and Albain. (Co-assignment to Survivorship<br />

Committee) Activated: 9/15/09; Closed 2/1/11.<br />

Proposed Studies<br />

■■<br />

S1202, “Phase III Study of Duloxetine for Treatment of<br />

Aromatase Inhibitor-Associated Musculoskeletal Symptoms in<br />

Women with Early Stage Breast Cancer.” Drs. Henry and Schott.<br />

Protocol approved by DCP: 4/10/12, will open once S0927 has<br />

closed to accrual.<br />

Concepts in Development<br />

■ ■ “A Phase II Randomized Placebo-Controlled Study to Evaluate<br />

the Use of Menadione Topical Lotion in Patients with Cutaneous<br />

Toxicity Caused by Epidermal Growth Factor Receptor (HER1/<br />

EGFR) Inhibitors.” Drs. Wong, Ryan, Wade, & Moinpour. Seeking<br />

Industry funding. Examining other potential agents.<br />

■■<br />

■■<br />

GWAS analysis for oxaliplatin-associated neurotoxicity. Drs.<br />

Zell/Ambrosone.<br />

——<br />

R01 submitted with letters of support from both NSABP<br />

and the Alliance.<br />

Two surveys:<br />

——<br />

Dr. Wong: Knowledge and Attitudes Re: Safe Handling of<br />

Oral Chemotherapy Agents<br />

——<br />

Dr. Anne Jeffres: Role of Acupuncture in Oncology<br />

Committee Process<br />

■■<br />

Sign meeting attendance list<br />

■■<br />

Committee communication between <strong>Group</strong> <strong>Meeting</strong>s<br />

■■<br />

Monthly/bimonthly conference call Participants<br />

■■<br />

Cancer Control and Prevention Committee Reorganization<br />

■■<br />

Local Initiatives of interest and potentially feasible in SWOG<br />

Announcements<br />

Other Studies with Symptom Control and QOL Component<br />

■■<br />

S1007, “A Phase III, Randomized Clinical Trial of Standard<br />

Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with<br />

1-3 Positive Nodes, Hormone-responsive and Her2-Negative<br />

Breast Cancer according to Recurrence Score (RS).” Drs.<br />

Gonzales-Angulo, Meric-Bernstam, Hortobagyi, and Albain.<br />

Activated: 1/15/11.<br />

■■<br />

■■<br />

■■<br />

CTSU/C30610, “Phase III Comparison of Thoracic Radiotherapy<br />

Regimens in Patients with Limited Small Cell Lung Cancer Also<br />

Receiving Cisplatin and Etoposide.” Drs. Gadgeel and Gaspar.<br />

Activated: 4/1/08.<br />

CTSU/C90203, “A Randomized Phase III Study of Neo-<br />

Adjuvant Docetaxel and Androgen Deprivation Prior to Radical<br />

Prostatectomy Versus Immediate Radical Prostatectomy in<br />

Patients with High-Risk, Clinically Localized Prostate Cancer.”<br />

Dr. Kim. Activated: 7/1/07.<br />

CTSU/E1411, “Intergroup Randomized Phase 2 Four Arm Study<br />

in Patients >/= 60 with Previously Untreated Mantle Cell<br />

SWOG • Leading Cancer Research. Together.


52 <strong>Fall</strong> <strong>2012</strong><br />

SYMPTOM CONTROL & QUALITY OF LIFE COMMITTEE<br />

■■<br />

Lymphoma of Therapy with: Arm A = Rituximab+Bendamustine<br />

Followed by Rituximab Consolidation (RB -->R); Arm B = Ri<br />

tuximab+Bendamustine+Bortezomib Followed By Rituximab<br />

Consolidation (RBV--> R), Arm C = Rituximab+Bendamustine<br />

Followed by Lenalidomide+Rituximab Consolidation (RB --> LR)<br />

or Arm D = Rituximab+Bendamustine+Bortezomib Followed by<br />

Lenalidomide+Rituximab Consolidation (RBV --> LR).” Dr. Till.<br />

Activated: 6/15/12.<br />

CTSU/E1609, “A Phase III Randomized Study of Adjuvant<br />

Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon<br />

a-2b for Resected High-Risk Melanoma.” Dr. Flaherty. Activated:<br />

7/15/11.<br />

■■<br />

■■<br />

and an Anthracycline and/or a Taxane.” Dr. Hannah M. Liden.<br />

Activated: 8/15/08; Closed: 6/8/12.<br />

CTSU/R0848, “A Phase III Trial Evaluating Both Erlotinib<br />

and Chemoradiation as Adjuvant Treatment for Patients with<br />

Resected Head of Pancreas Adenocarcinoma.” Dr. Philip.<br />

Activated: 12/15/09.<br />

CTSU/R1010, “A Phase III Trial Evaluating the Addition of<br />

Trastuzumab to Trimodality Treatment Of HER2-Overexpressing<br />

Esophageal Adenocarcinoma.” Dr. Leichman. Activated: 9/1/11.<br />

Publications<br />

■■<br />

■■<br />

■■<br />

■■<br />

■■<br />

■■<br />

■■<br />

CTSU/E2108, “A Randomized Phase III Trial of the Value of<br />

Early Local Therapy for the Intact Primary Tumor in Women with<br />

Metastatic Breast Cancer.” Dr. Lee. Activated: 3/15/11.<br />

CTSU/E3805, “CHAARTED: ChemoHormonal Therapy versus<br />

Androgen Ablation Randomized Trial for Extensive Disease in<br />

Prostate Cancer.” Dr. Garcia. Activated: 9/1/08.<br />

CTSU/E3A06, “Randomized Phase III Trial of Lenalidomide<br />

Versus Observation Alone in Patients with Asymptomatic<br />

Smoldering Multiple Myeloma.” Drs. Dhodapkar and<br />

Shaughnessy. Activated: 2/1/11.<br />

CTSU/MA32, “A Phase III Randomized Trial of Metformin<br />

versus Placebo on Recurrence and Survival in Early Stage Breast<br />

Cancer.” Dr. Hershman. Activated: 9/15/10.<br />

CTSU/N1048, “A Phase II/III trial of Neoadjuvant FOLFOX, with<br />

Selective Use of Combined Modality Chemoradiation versus<br />

Preoperative Combined ModalityChemoradiation for Locally<br />

Advanced Rectal Cancer Patients Undergoing Low Anterior<br />

Resection with Total Mesorectal Excision.” Dr. Eng. Activated:<br />

4/15/12.<br />

CTSU/N107C, “A Phase III Trial of Post-Surgical Stereotactic<br />

Radiosurgery Compared with Whole Brain Radiotherapy (WBRT)<br />

for Resected Metastatic Brain Disease.” Dr. Gaspar. Activated:<br />

12/1/11.<br />

CTSU/N0733, “Randomized Phase II Trial of Capecitabine and<br />

Lapatinib with or without IMC-A12 in Patients with HER2<br />

Positive Breast Cancer Previously Treated with Trastuzumab<br />

The publications listed below are those that have been received in<br />

published, submitted or accepted form by the <strong>Group</strong> Chair’s Office<br />

since the Spring <strong>2012</strong> meeting agenda booklet publcation list.<br />

Published/Accepted Manuscripts<br />

■■<br />

S0715 Randomized double-blind placebo-controlled trial<br />

of acetyl-l-carnitine for the prevention of taxane induced<br />

neuropathy in women undergoing adjuvant breast cancer<br />

therapy. D Hershman, J Unger, K Crew, L Minasian, C<br />

Moinpour, L Hansen, D Lew, L Fehrenbacher, J Wade, S Wong, G<br />

Hortobagyi, F Meyskens, K Albain. Journal of Clinical Oncology,<br />

resubmitted 8/12 (also listed under Breast Committee) .<br />

■■<br />

S9217 Health-related quality of life findings for the Prostate<br />

Cancer Prevention Trial. CM Moinpour, AK Darke, GW<br />

Donaldson, D Cespedes, CR Johnson, PA Ganz, DL Patrick, JE<br />

Ware, SA Shumaker, FL Meyskens, IM Thompson. Journal of the<br />

National Cancer Institute, accepted 8/21/12.<br />

Submitted Manuscripts<br />

No publication information for this cycle.<br />

SWOG • Leading Cancer Research. Together.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 53<br />

Cancer Control and Prevention Committees<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

Outcomes &<br />

Comparative<br />

Effectiveness Prevention<br />

Cancer<br />

Survivorship<br />

Symptom Control & Quality of Life<br />

S1007 S1105 S00002 S0000B S0000D S0812 C70807 S0230 S1008 C30610 C70301 C90203 CTN0701<br />

Abramson Cancer Ctr - - 174 13 23 - - - - - - - -<br />

Altamira Family Med - - 73 - - - - - - - - - -<br />

Anne Arundel Med Ctr - - 33 5 - - - - - - - - -<br />

Arizona Cancer Ctr - - 218 - 100 - - - - - - - -<br />

Arizona, U of - - - - - - - - - - - - -<br />

Arkansas, U of 6 1 - - - - - - - 1 - - -<br />

Arkansas, Univ of - - 20 - - - - - - - - - -<br />

Atlanta Reg CCOP 11 - 87 - - - 1 - - - - - -<br />

Aultman Hospital - - 22 - - - - - - - - - -<br />

Baptist Hosp East - - 151 - - - - - - - - - -<br />

Baptist Regional - - 90 10 - - - - - - - - -<br />

Bassett Research Ins - - 35 6 - - - - - - - - -<br />

Bay Area CCOP 1 - 114 18 1 - - - - - - - -<br />

Baylor Univ Med Ctr - - 47 - - - - - - - - - -<br />

Beaumont CCOP 2 - - - - - 4 - - - - - -<br />

Berkshire Hem/Onc - - 42 - - - - - - - - - -<br />

Beth Israel Deacones - - 8 - - - - - - - - - -<br />

Boston MC MBCCOP - - - - - - - - - - - - -<br />

Boston Medical Ctr - - 20 - - - - - - - - - -<br />

Boston Univ Med Ctr - - - - - - - - - - - - -<br />

Brooke Army Med Ctr 1 - - - - - - 1 - - - 3 -<br />

Camcare Health - - 12 - - - - - - - - - -<br />

Capital Region PC - - 271 - - - - - - - - - -<br />

Carle Cancer Center - - 205 2 5 - - - - - - - -<br />

Cascadia Cancer Prev - - 125 95 165 - - - - - - - -<br />

Cedar Rapids CCOP - - 79 15 30 - - - - - - - -<br />

Cedars-Sinai Med Ctr - - - - - - 1 - - - - - -<br />

Central Baptist Hosp - - 19 - - - - - - - - - -<br />

Central IL CCOP 3 - 111 - - - - - - 5 - - -<br />

Central PA Hem & Med - - 5 - - - - - - - - - -<br />

Centro Clinico - - 23 - - - - - - - - - -<br />

Chicago Hospitals, U - - 16 - - - - - - - - - -<br />

Christiana Care Hlth - - 47 7 - - - - - - - - -<br />

Cincinnati MC, U of 4 - - - - - - - - - - - -<br />

Cincinnati, Univ of - - 9 - - - - - - - - - -<br />

City of Hope Med Ctr 8 - 56 - - 6 - 2 - - - 10 -<br />

Cleveland Clinic - - 69 - - - - - - - - - -<br />

Cleveland Clinic OH 10 - - - - - 1 3 - - - - -<br />

Colorado Ca Res Prog - - 112 8 52 - - - - - - - -<br />

Colorado, U of 2 - - - - - 1 - - - - 12 -<br />

Colorado, Univ of - - 569 56 - - - - - - - - -<br />

Columbia River CCOP - - 67 - - - - - - - - - -<br />

Columbia University 4 7 13 - - 1 - 2 - - - - -<br />

Columbus CCOP 6 1 37 - - - - 1 - - 10 - -<br />

Conemaugh Mem MC - - 3 - - - - - - - - - -<br />

Connecticut, Univ of - - 38 - - - - - - - - - -<br />

DC United - - 42 - - - - - - - - - -<br />

SWOG • Leading Cancer Research. Together.


54 <strong>Fall</strong> <strong>2012</strong><br />

Cancer Control and Prevention Committees<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

Outcomes &<br />

Comparative<br />

Effectiveness Prevention<br />

Cancer<br />

Survivorship<br />

Symptom Control & Quality of Life<br />

S1007 S1105 S00002 S0000B S0000D S0812 C70807 S0230 S1008 C30610 C70301 C90203 CTN0701<br />

Dartmouth Hitchcock - - 1 - - - - - - - - - -<br />

Davis, U of CA 5 - - - - - - 2 - 7 7 13 2<br />

Dayton CCOP 4 1 183 - - - - 1 - - - - -<br />

Dickstein CTC - - 23 - - - - - - - - - -<br />

Downstate Med Ctr - - 80 - - - - - - - - - -<br />

Duluth CCOP - - 94 42 80 - - - - - - - -<br />

Faxton-St Luke's - - 46 - - - - - - - - - -<br />

Fox Chase Cancer Ctr - - 176 26 37 - - - - - - - -<br />

Galveston, U of TX - - - - - - - - - - - - -<br />

Geisinger Clinic - - 91 - 77 - - - - - - - -<br />

George Washington U - - 282 74 208 - - - - - - - -<br />

Glendale Mem Hosp - - 40 - - - - - - - - - -<br />

Good Samaritan Hosp - - 72 22 - - - - - - - - -<br />

Good Samaritan MC - - 15 - - - - - - - - - -<br />

Grand Rapids CCOP 2 4 241 - 167 - - - - - - - -<br />

Greenville CCOP 1 4 107 - 68 - - 1 - - - - -<br />

Gulf Coast MBCCOP 2 - 3 - - - - - - - - - -<br />

H Lee Moffitt CC - - 77 - - - - - - - - 2 1<br />

Harbor-UCLA - - 448 - 54 - - - - - - - -<br />

Harrington CC 1 - 34 10 - - - - - - - - -<br />

Harris Methodist - - 24 - - - - - - - - - -<br />

Harrison Peeples HCC - - 41 - - - - - - - - - -<br />

Hawaii CCOP - - 61 15 - - - - - - - - -<br />

Hawaii MBCCOP, U of 3 - - - - - - - - - - - -<br />

Hem-Onc Assoc of CNY - - 51 5 41 - - - - - - - -<br />

Henry Ford Hosp - - 88 10 51 - - 1 - - - 1 -<br />

Huntington Mem Hosp - - 13 5 - - - - - - - - -<br />

INCan 12 - - - - - - - - - - - -<br />

INTEGRIS Oncology - - 99 - - - - - - - - - -<br />

Illinois, Univ of - - 389 350 420 - - - - - - - -<br />

Indiana University - - 17 - - - - - - - - - -<br />

Iowa Hosp, Univ of - - 136 - - - - - - - - - -<br />

Iowa Oncology CCOP - - 174 48 70 - - - - - - - -<br />

Ireland Cancer Ctr - - 28 7 - - - - - - - - -<br />

Irvine, U of CA 6 - - - - - - - - - - - -<br />

Irvine, Univ of CA - - 26 - - - - - - - - - -<br />

Johns Hopkins Univ - - 13 - - - - - - - - - -<br />

Johnson City Med Ctr - - 24 - - - - - - - - - -<br />

Kaiser Permanente-GA - - 49 3 - - - - - - - - -<br />

Kaiser-Oakland - - 26 5 - - - - - - - - -<br />

KaiserPermanenteNCAL 21 - - - - - - - - 1 - - -<br />

Kalamazoo CCOP - - 128 - 70 - - - - - - - -<br />

Kansas City CCOP 2 - 53 - 26 - - - - - - - -<br />

Kansas, U of 2 1 - - - - 2 1 - - - 11 -<br />

Kentucky, U of 8 - - - - - 1 - - - - - -<br />

Kentucky, Univ of - - 23 - - - - - - - - - -<br />

Kimmel Cancer Ctr - - 29 5 - - - - - - - - -<br />

SWOG • Leading Cancer Research. Together.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 55<br />

Cancer Control and Prevention Committees<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

Outcomes &<br />

Comparative<br />

Effectiveness Prevention<br />

Cancer<br />

Survivorship<br />

Symptom Control & Quality of Life<br />

S1007 S1105 S00002 S0000B S0000D S0812 C70807 S0230 S1008 C30610 C70301 C90203 CTN0701<br />

King Faisal Spec Hos - - - - - - - 3 - - - - -<br />

Knoxville, U of TN - - 53 19 47 - - - - - - - -<br />

Kootenai Cancer Ctr - - 14 6 - - - - - - - - -<br />

LDS Hospital - - 106 - - - - - - - - - -<br />

LSU-New Orleans - - 15 - - - - - - - - - -<br />

LSU-New Orleans CCOP - - - - - - 1 - - - - 2 -<br />

LSU-Shreveport - - 91 - - - - - - - - - -<br />

LSU-Shreveport CCOP - - - - - - - - - - - 1 -<br />

Lahey Clinic Med Ctr 2 - 54 - - 5 - - - - - - -<br />

Lawrence & Mem Hosp - - 30 7 - - - - - - - - -<br />

Lehigh Valley Hosp - - 91 5 - - - - - - - - -<br />

Lionel B. Katchem - - - 6 - - - - - - - - -<br />

Los Angeles, U of CA - - 40 11 - - - - - - - - -<br />

Loyola University 8 - 31 7 - - - 2 2 - - 11 -<br />

MD Anderson 44 - 272 96 225 - - 2 - - - 3 -<br />

MUSC, Hollings CC 4 - - - - - - - - 1 - - -<br />

Main Line/Lankenau - - 19 1 - - - - - - - - -<br />

MaineGeneral MC - - 9 - - - - - - - - - -<br />

Marquette Gen Hosp - - 19 - - - - - - - - - -<br />

Marshfield Clinic - - 99 - - - - - - - - - -<br />

Martin Memorial CC - - 16 3 - - - - - - - - -<br />

Maryland, Univ of - - 9 - - - - - - - - - -<br />

Mayo Clinic - - 4 - - - - - - - - - -<br />

Med Col of Wisconsin - - 83 - - - - - - - - - -<br />

Meharry Med College - - 5 - - - - - - - - - -<br />

MeritCare Hosp CCOP - - 104 39 88 - - - - - - - -<br />

Methodist Cancer Ctr - - 23 - - - - - - - - - -<br />

Methodist Hospital 1 - - - - - - - - - - - -<br />

Methodist, Dallas - - 52 1 10 - - - - - - - -<br />

Metro-Minnesota CCOP - - 155 19 102 - - - - - - - -<br />

Miami, Univ of - - 6 - - - - - - - - - -<br />

Michigan CRC CCOP 12 3 171 - - - - - - - - 2 -<br />

Michigan, U of 8 - - - - - - 3 - 1 - - -<br />

Midtown Urology PC - - 15 - - - - - - - - - -<br />

Miguel Sosa Padilla - - 31 - - - - - - - - - -<br />

Mississippi, Univ of 1 - 154 36 88 - - - - - 7 - -<br />

Missouri Baptist MC - - 105 - - - - - - - - - -<br />

Missouri Valley CCOP - - 86 - - - - - - - - - -<br />

Montana CCOP 1 - 30 6 - - - 2 - - - - -<br />

Montefiore MC, N Div - - 3 - - - - - - - - - -<br />

Mount Sinai CCOP - - 130 - 54 - - - - - - - -<br />

Mt Zion Cancer Ctr - - 9 - - - - - - - - - -<br />

NY Methodist Hosp - - 11 4 - - - - - - - - -<br />

National Cancer Ctr 10 - - - - - - - - - - - -<br />

Nebraska, Univ of - - 65 - - - - - - - - - -<br />

Nevada Cancer Inst - - - - - - - - - - - - -<br />

New Mexico MBCCOP 4 1 - - - - - - - - - 1 -<br />

SWOG • Leading Cancer Research. Together.


56 <strong>Fall</strong> <strong>2012</strong><br />

Cancer Control and Prevention Committees<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

Outcomes &<br />

Comparative<br />

Effectiveness Prevention<br />

Cancer<br />

Survivorship<br />

Symptom Control & Quality of Life<br />

S1007 S1105 S00002 S0000B S0000D S0812 C70807 S0230 S1008 C30610 C70301 C90203 CTN0701<br />

New Mexico, Univ of - - 12 - - - - - - - - - -<br />

North Shore CCOP - - 16 - - - - - - - - - -<br />

NorthShore Univ - - 31 - - - - - - - - - -<br />

Northern Indiana CRC - - 110 37 25 - - - - - - - -<br />

Northern NJ Ca Assoc - - 15 - - - - - - - - - -<br />

Northwest CCOP 6 - 161 - - - - - - - - - -<br />

Northwestern Univ - - 91 21 18 - - - - - - - -<br />

Ochsner CCOP - - 11 - - - - - - - - - -<br />

Ohio State Univ - - 20 2 - - - - - - - - -<br />

Oklahoma, Univ of - - 56 - - - - - - - - - -<br />

Oregon Hlth Sci Univ - - 48 19 - - - 3 - - - 1 -<br />

Orocovis Med Ctr - - 52 - - - - - - - - - -<br />

Ottawa General Hosp - - 54 - - - - - - - - - -<br />

Our Lady, Bellefonte - - 25 - - - - - - - - - -<br />

Ozarks CCOP - - 27 - - - - - - - - - -<br />

Ozarks Reg CCOP 3 2 - - - - - 2 - - - - -<br />

Pittsburgh Ca Inst - - 18 - - - - - - - - - -<br />

Princess Margaret - - 33 - - - - - - - - - -<br />

Prostate Cancer Ctr - - 49 - - - - - - - - - -<br />

Providence Hosp - - - - - - - - - 2 - - -<br />

Puget Sound 5 - - - - - 1 2 1 - - 1 -<br />

Queens Hospital Ctr - - 3 - - - - - - - - - -<br />

Regional CC-Waukesha - - 33 - - - - - - - - - -<br />

Regional Cancer Ctr - - 15 - - - - - - - - - -<br />

Rochester, Univ of - - 16 - - - - 1 - - - 2 -<br />

Roswell Park - - 43 - - - - - - - - - -<br />

Rush Univ Med Ctr - - 214 - - - - - - - - - -<br />

SELECT Coord Center - - 495 - 3,219 - - - - - - - -<br />

SUNY Stony Brook - - 256 45 - - - - - - - - -<br />

SW Cancer & Res Ctr - - 16 3 - - - - - - - - -<br />

San Antonio, U of TX 2 - 68 - 49 - 3 - - 3 1 - -<br />

San Diego, U of CA - - 1,162 - 306 - - - - - - - -<br />

San Juan MBCCOP - - 55 - - - - - - - - - -<br />

Sanford Cancer Ctr - - 109 27 37 - - - - - - - -<br />

Santa Rosa Mem Hosp - - 31 - - - - - - - - - -<br />

Schiffler Cancer Ctr - - 58 - 49 - - - - - - - -<br />

Scott & White CCOP - - 98 25 - - - - - - - - -<br />

Sentara Cancer Inst - - 69 - - - - - - - - - -<br />

Sierra Nevada Mem - - 49 - - - - - - - - - -<br />

So Calif, U of 7 - 22 - - - - 6 - - - 4 -<br />

Somerset Med Ctr - - 10 - - - - - - - - - -<br />

Southeast CCC CCOP 9 - 366 80 238 - - 2 - - - - -<br />

Southern Nevada CCOP 1 - 115 16 50 - - - - - - - -<br />

St Francis Hospital - - 28 - - - - - - - - - -<br />

St Louis CCOP 2 - - - - 1 - - - - 3 - -<br />

St Louis University 1 - - - - - - - - - - - -<br />

St Luke's Mt State - - 87 29 - - - - - - - - -<br />

SWOG • Leading Cancer Research. Together.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 57<br />

Cancer Control and Prevention Committees<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

Outcomes &<br />

Comparative<br />

Effectiveness Prevention<br />

Cancer<br />

Survivorship<br />

Symptom Control & Quality of Life<br />

S1007 S1105 S00002 S0000B S0000D S0812 C70807 S0230 S1008 C30610 C70301 C90203 CTN0701<br />

St Vincent Hospital - - 71 - 68 - - - - - - - -<br />

Stanford University - - 63 - - - - - - - - - -<br />

Stormont-Vail Health - - 97 26 75 - - - - - - - -<br />

Summa Health System - - 27 8 - - - - - - - - -<br />

Sunnybrook Hlth SC - - 99 - - - - - - - - - -<br />

Sutter Hlth CRG-East - - 126 - - - - - - - - - -<br />

Swedish Medical Ctr - - 559 150 263 - - - - - - - -<br />

Tennessee, U of 2 - - - - - - 2 - - - - -<br />

Thompson Ca Surv Ctr - - 75 18 - - - - - - - - -<br />

Thunder Bay Reg HSC - - 24 - - - - - - - - - -<br />

Toledo CCOP - - 116 44 68 - - - - - - - -<br />

Trinitas Hospital - - 21 - 16 - - - - - - - -<br />

Tulane University 3 - 23 - 3 - - - - - - - -<br />

Tyler, U of TX - - 32 - - - - - - - - - -<br />

UAB Div of Prev Med - - 63 9 14 - - - - - - - -<br />

US Oncology - - 84 - - - - - - - - - -<br />

Upstate Carolina - 2 871 154 568 - - - - - - 1 -<br />

Utah, U of 3 - - - - 3 10 - - - - - -<br />

VAMC Asheville - - 1 - - - - - - - - - -<br />

VAMC Boston - - 67 41 - - - - - - - - -<br />

VAMC Cleveland - - 78 - - - - - - - - - -<br />

VAMC Dallas - - 69 - - - - - - - - - -<br />

VAMC Durham - - 13 - - - - - - - - - -<br />

VAMC Fargo - - 83 71 109 - - - - - - - -<br />

VAMC Gainesville - - 25 - - - - - - - - - -<br />

VAMC Hines - - 51 28 50 - - - - - - - -<br />

VAMC Houston - - 20 - - - - - - - - - -<br />

VAMC James A. Haley - - 4 - - - - - - - - - -<br />

VAMC Kansas City - - 74 22 - - - - - - - - -<br />

VAMC Loma Linda - - 28 8 - - - - - - - - -<br />

VAMC Long Beach - - 21 - - - - - - - - - -<br />

VAMC Louisville - - 31 - - - - - - - - - -<br />

VAMC McGuire - - 6 - - - - - - - - - -<br />

VAMC Minneapolis - - 137 84 3 - - - - - - - -<br />

VAMC New Jersey - - 18 - - - - - - - - - -<br />

VAMC Northport - - 14 - - - - - - - - - -<br />

VAMC Pittsburgh - - 16 - - - - - - - - - -<br />

VAMC Puget Sound - - 30 - - - - - - - - - -<br />

VAMC So Arizona - - 46 - - - - - - - - - -<br />

VAMC St Louis - - 16 - - - - - - - - - -<br />

VAMC Stratton - - 8 - - - - - - - - - -<br />

VAMC Syracuse - - 19 8 - - - - - - - - -<br />

VAMC Tuscaloosa - - 2 - - - - - - - - - -<br />

VAMC Washington DC - - 36 19 25 - - - - - - - -<br />

VAMC Western NY - - 5 - - - - - - - - - -<br />

VCU Massey CC - - 63 - - - - - - - - - -<br />

Valley Hospital - - 10 - - - - - - - - - -<br />

SWOG • Leading Cancer Research. Together.


58 <strong>Fall</strong> <strong>2012</strong><br />

Cancer Control and Prevention Committees<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

Outcomes &<br />

Comparative<br />

Effectiveness Prevention<br />

Cancer<br />

Survivorship<br />

Symptom Control & Quality of Life<br />

S1007 S1105 S00002 S0000B S0000D S0812 C70807 S0230 S1008 C30610 C70301 C90203 CTN0701<br />

Vancouver Hospital - - 241 47 - - - - - - - - -<br />

Vanderbilt Univ - - 86 - - - - - - - - - -<br />

Vermont Cancer Ctr - - 55 1 - - - - - - - - -<br />

Virginia Mason CCOP 10 - 24 4 - - 5 - - - - 10 -<br />

WNY Urology Assoc - - - 3 - - - - - - - - -<br />

WVU-Morgantown - - 14 - - - - - - - - - -<br />

Wake Forest Univ - - 12 - - - - - - - - - -<br />

Walter Reed AMC - - 94 42 - - - - - - - - -<br />

Washington Univ - - 70 18 - - - - - - - - -<br />

Wayne State Univ 7 - - - - - - - - 1 7 4 -<br />

Wayne State/Karmanos - - 7 - - - - - - - - - -<br />

West Clinic - - 13 - - - - - - - - - -<br />

Western Reg CCOP - - 44 - - - - - - - - - -<br />

Wichita CCOP 12 9 162 82 143 - - 8 - 12 - - -<br />

Wilford Hall Med Ctr - - 250 78 150 - - - - - - - -<br />

William Beau Hosp - - 215 26 108 - - - - - - - -<br />

Wisconsin, Univ of - - 91 - - - - - - - - - -<br />

Yale University 2 - - - - - - - - - - - -<br />

York Cancer Center - - 36 13 - - - - - - - - -<br />

ACOSOG 13 - - - - - - - - - - - -<br />

ANZ BCTG/ IBCSG - - - - - - - 58 - - - - -<br />

CALGB 75 - - - - - - 14 - - - - -<br />

ECOG 92 - - - - - - 86 - - - - -<br />

FSS/ IBCSG - - - - - - - 46 - - - - -<br />

GOG 3 - - - - - - - - - - - -<br />

NCCTG 29 - - - - - - - - - - - -<br />

NCIC 10 - - - - - - - - - - - -<br />

NSABP 48 - - - - - - - - - - - -<br />

RTOG 1 - - - - - - - - - - - -<br />

Total 568 36 17,780 2,436 8,013 16 31 257 3 34 35 95 3<br />

Note: Some studies may not be listed because they were either closed prior to July 1, 2011 or because they are currently active but have not had any accrual through September 6, <strong>2012</strong>.<br />

SWOG • Leading Cancer Research. Together.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 59<br />

Cancer Control and Prevention Committees<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

Symptom Control & Quality of Life<br />

E1609 E2108 E2906 E3805 E3A06 MA32 N0733 PR11 R04 R0848 R1010 S0622 S0702 S0715 S0927 S1013 S1200<br />

Abramson Cancer Ctr - - - - - - - - - - - - - - - - -<br />

Altamira Family Med - - - - - - - - - - - - - - - - -<br />

Anne Arundel Med Ctr - - - - - - - - - - - - - - - - -<br />

Arizona Cancer Ctr - - - - - - - - - - - - - - - - -<br />

Arizona, U of 5 - - - - 10 - - - - - - - - - - -<br />

Arkansas, U of 17 - - 1 - - - - - - - 8 11 6 3 - -<br />

Arkansas, Univ of - - - - - - - - - - - - - - - - -<br />

Atlanta Reg CCOP - - - - - - - - - - - - 14 7 - - -<br />

Aultman Hospital - - - - - - - - - - - - - - - - -<br />

Baptist Hosp East - - - - - - - - - - - - - - - - -<br />

Baptist Regional - - - - - - - - - - - - - - - - -<br />

Bassett Research Ins - - - - - - - - - - - - - - - - -<br />

Bay Area CCOP - - - - - 5 - - - - - 1 5 5 3 - -<br />

Baylor Univ Med Ctr 8 - - - - - - - - - - - - - - - -<br />

Beaumont CCOP - - - - - 17 - 1 - - - 1 29 7 - - -<br />

Berkshire Hem/Onc - - - - - - - - - - - - - - - - -<br />

Beth Israel Deacones - - - - - - - - - - - - - - - - -<br />

Boston MC MBCCOP - - - 1 - - - - - - - - - 1 - - -<br />

Boston Medical Ctr - - - - - - - - - - - - - - - - -<br />

Boston Univ Med Ctr - - - 1 - - - - - - - 2 - - - - -<br />

Brooke Army Med Ctr - - - - - 7 - - 4 - - 1 6 1 - - -<br />

Camcare Health - - - - - - - - - - - - - - - - -<br />

Capital Region PC - - - - - - - - - - - - - - - - -<br />

Carle Cancer Center - - - - - - - - - - - - - - - - -<br />

Cascadia Cancer Prev - - - - - - - - - - - - - - - - -<br />

Cedar Rapids CCOP - - - - - - - - - - - - - - - - -<br />

Cedars-Sinai Med Ctr - - - - - - - - - - - - - - - - -<br />

Central Baptist Hosp - - - - - - - - - - - - - - - - -<br />

Central IL CCOP - - - - - 26 - - - - 1 8 133 4 3 4 -<br />

Central PA Hem & Med - - - - - - - - - - - - - - - - -<br />

Centro Clinico - - - - - - - - - - - - - - - - -<br />

Chicago Hospitals, U - - - - - - - - - - - - - - - - -<br />

Christiana Care Hlth - - - - - - - - - - - - - - - - -<br />

Cincinnati MC, U of 2 - - - - - - - - - - - 9 - 2 - -<br />

Cincinnati, Univ of - - - - - - - - - - - - - - - - -<br />

City of Hope Med Ctr - - - - - - - - - - - - 15 - - - -<br />

Cleveland Clinic - - - - - - - - - - - - - - - - -<br />

Cleveland Clinic OH 1 - - 45 - 19 - - - - - 2 15 18 - - -<br />

Colorado Ca Res Prog - - - - - - - - - - - - - - - - -<br />

Colorado, U of 12 - - 11 - 15 - 3 - - - 7 26 12 - - -<br />

Colorado, Univ of - - - - - - - - - - - - - - - - -<br />

Columbia River CCOP - - - - - 3 - - - - - - 49 3 - - -<br />

Columbia University 1 2 - 5 - 19 - - 4 1 - - 15 8 3 - 1<br />

Columbus CCOP - - - - - - - - - - - 3 16 1 2 - -<br />

Conemaugh Mem MC - - - - - - - - - - - - - - - - -<br />

Connecticut, Univ of - - - - - - - - - - - - - - - - -<br />

DC United - - - - - - - - - - - - - - - - -<br />

SWOG • Leading Cancer Research. Together.


60 <strong>Fall</strong> <strong>2012</strong><br />

Cancer Control and Prevention Committees<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

Symptom Control & Quality of Life<br />

E1609 E2108 E2906 E3805 E3A06 MA32 N0733 PR11 R04 R0848 R1010 S0622 S0702 S0715 S0927 S1013 S1200<br />

Dartmouth Hitchcock - - - - - - - - - - - - - - - - -<br />

Davis, U of CA 6 1 - 10 - 12 - - 3 - - 5 23 26 7 1 -<br />

Dayton CCOP 1 - - - - - - - - - - - 20 1 5 - -<br />

Dickstein CTC - - - - - - - - - - - - - - - - -<br />

Downstate Med Ctr - - - - - - - - - - - - - - - - -<br />

Duluth CCOP - - - - - - - - - - - - - - - - -<br />

Faxton-St Luke's - - - - - - - - - - - - - - - - -<br />

Fox Chase Cancer Ctr - - - - - - - - - - - - - - - - -<br />

Galveston, U of TX - - - - - - - - - - - - 5 - - - -<br />

Geisinger Clinic - - - - - - - - - - - - - - - - -<br />

George Washington U - - - - - - - - - - - - - - - - -<br />

Glendale Mem Hosp - - - - - - - - - - - - - - - - -<br />

Good Samaritan Hosp - - - - - - - - - - - - - - - - -<br />

Good Samaritan MC - - - - - - - - - - - - - - - - -<br />

Grand Rapids CCOP 3 - - - - - - - - - - - 18 9 6 - -<br />

Greenville CCOP 1 - - - 6 - - - - 1 - - 16 9 6 - -<br />

Gulf Coast MBCCOP - - - 1 - - - - - - - - 11 - 1 - -<br />

H Lee Moffitt CC 15 1 - - - 9 - - 6 - - - 113 4 - - -<br />

Harbor-UCLA - - - - - - - - - - - - - - - - -<br />

Harrington CC - - - - - - - - 3 - - - 14 6 - - -<br />

Harris Methodist - - - - - - - - - - - - - - - - -<br />

Harrison Peeples HCC - - - - - - - - - - - - - - - - -<br />

Hawaii CCOP - - - - - - - - - - - - - - - - -<br />

Hawaii MBCCOP, U of - - - - - 9 - - - - - - 32 3 - - -<br />

Hem-Onc Assoc of CNY - - - - - - - - - - - - - - - - -<br />

Henry Ford Hosp - - - - - - - - - - - - 26 6 - - -<br />

Huntington Mem Hosp - - - - - - - - - - - - - - - - -<br />

INCan - - - - - - - - - - - - 40 - - - -<br />

INTEGRIS Oncology - - - - - - - - - - - - - - - - -<br />

Illinois, Univ of - - - - - - - - - - - - - - - - -<br />

Indiana University - - - - - - - - - - - - - - - - -<br />

Iowa Hosp, Univ of - - - - - - - - - - - - - - - - -<br />

Iowa Oncology CCOP - - - - - - - - - - - - - - - - -<br />

Ireland Cancer Ctr - - - - - - - - - - - - - - - - -<br />

Irvine, U of CA 1 - - - - - - - 1 1 - - 4 1 - - -<br />

Irvine, Univ of CA - - - - - - - - - - - - - - - - -<br />

Johns Hopkins Univ - - - - - - - - - - - - - - - - -<br />

Johnson City Med Ctr - - - - - - - - - - - - - - - - -<br />

Kaiser Permanente-GA - - - - - - - - - - - - - - - - -<br />

Kaiser-Oakland - - - - - - - - - - - - - - - - -<br />

KaiserPermanenteNCAL 2 - - - - 144 2 - - - - - - 69 5 - -<br />

Kalamazoo CCOP - - - - - - - - - - - - - - - - -<br />

Kansas City CCOP - - - - - 10 - - - - - - 31 - - - -<br />

Kansas, U of 2 - - 2 - - - - 11 1 - - 25 1 - - -<br />

Kentucky, U of - - 1 8 - - - - - - - - - - - - -<br />

Kentucky, Univ of - - - - - - - - - - - - - - - - -<br />

Kimmel Cancer Ctr - - - - - - - - - - - - - - - - -<br />

SWOG • Leading Cancer Research. Together.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 61<br />

Cancer Control and Prevention Committees<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

Symptom Control & Quality of Life<br />

E1609 E2108 E2906 E3805 E3A06 MA32 N0733 PR11 R04 R0848 R1010 S0622 S0702 S0715 S0927 S1013 S1200<br />

King Faisal Spec Hos - - - - - - - - - - - - 17 - - - -<br />

Knoxville, U of TN - - - - - - - - - - - - - - - - -<br />

Kootenai Cancer Ctr - - - - - - - - - - - - - - - - -<br />

LDS Hospital - - - - - - - - - - - - - - - - -<br />

LSU-New Orleans - - - - - - - - - - - - - - - - -<br />

LSU-New Orleans CCOP - - - - - 2 - - - - - - - 1 - - -<br />

LSU-Shreveport - - - - - - - - - - - - - - - - -<br />

LSU-Shreveport CCOP - - - - - - - - 2 - - - 17 7 2 - -<br />

Lahey Clinic Med Ctr 4 - - - - 2 - - - - - - - - - - -<br />

Lawrence & Mem Hosp - - - - - - - - - - - - - - - - -<br />

Lehigh Valley Hosp - - - - - - - - - - - - - - - - -<br />

Lionel B. Katchem - - - - - - - - - - - - - - - - -<br />

Los Angeles, U of CA - - - - - - - - - - - - - - - - -<br />

Loyola University 1 - 1 6 - 5 - - - 3 - 2 77 10 9 - -<br />

MD Anderson - - - - - - - - - - - - - - - - -<br />

MUSC, Hollings CC - 1 - - - 7 - - - - - - 7 - - - -<br />

Main Line/Lankenau - - - - - - - - - - - - - - - - -<br />

MaineGeneral MC - - - - - - - - - - - - - - - - -<br />

Marquette Gen Hosp - - - - - - - - - - - - - - - - -<br />

Marshfield Clinic - - - - - - - - - - - - - - - - -<br />

Martin Memorial CC - - - - - - - - - - - - - - - - -<br />

Maryland, Univ of - - - - - - - - - - - - - - - - -<br />

Mayo Clinic - - - - - - - - - - - - - - - - -<br />

Med Col of Wisconsin - - - - - - - - - - - - - - - - -<br />

Meharry Med College - - - - - - - - - - - - - - - - -<br />

MeritCare Hosp CCOP - - - - - - - - - - - - - - - - -<br />

Methodist Cancer Ctr - - - - - - - - - - - - - - - - -<br />

Methodist Hospital - - - - - - - - - - - - - - 1 - -<br />

Methodist, Dallas - - - - - - - - - - - - - - - - -<br />

Metro-Minnesota CCOP - - - - - - - - - - - - - - - - -<br />

Miami, Univ of - - - - - - - - - - - - - - - - -<br />

Michigan CRC CCOP - - - - - - - - - - - 9 30 29 10 - -<br />

Michigan, U of 2 - - 8 - 24 - - - - - 13 18 21 - - -<br />

Midtown Urology PC - - - - - - - - - - - - - - - - -<br />

Miguel Sosa Padilla - - - - - - - - - - - - - - - - -<br />

Mississippi, Univ of 1 - - 3 - 10 - - - - - 1 46 3 7 - -<br />

Missouri Baptist MC - - - - - - - - - - - - - - - - -<br />

Missouri Valley CCOP - - - - - - - - - - - - - - - - -<br />

Montana CCOP 1 - - 1 1 - - - - - - 6 17 2 5 - -<br />

Montefiore MC, N Div - - - - - - - - - - - - - - - - -<br />

Mount Sinai CCOP - - - - - - - - - - - - - - - - -<br />

Mt Zion Cancer Ctr - - - - - - - - - - - - - - - - -<br />

NY Methodist Hosp - - - - - - - - - - - - - - - - -<br />

National Cancer Ctr - - - - - - - - - - - - - - - - -<br />

Nebraska, Univ of - - - - - - - - - - - - - - - - -<br />

Nevada Cancer Inst - - - - - - - - - - - - 2 - - - -<br />

New Mexico MBCCOP - - - - - 9 - - - - - 2 7 11 1 - -<br />

SWOG • Leading Cancer Research. Together.


62 <strong>Fall</strong> <strong>2012</strong><br />

Cancer Control and Prevention Committees<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

Symptom Control & Quality of Life<br />

E1609 E2108 E2906 E3805 E3A06 MA32 N0733 PR11 R04 R0848 R1010 S0622 S0702 S0715 S0927 S1013 S1200<br />

New Mexico, Univ of - - - - - - - - - - - - - - - - -<br />

North Shore CCOP - - - - - - - - - - - - - - - - -<br />

NorthShore Univ - - - - - - - - - - - - - - - - -<br />

Northern Indiana CRC - - - - - - - - - - - - - - - - -<br />

Northern NJ Ca Assoc - - - - - - - - - - - - - - - - -<br />

Northwest CCOP 1 - - - - 22 1 - - 1 - 1 36 12 4 - -<br />

Northwestern Univ - - - - - - - - - - - - - - - - -<br />

Ochsner CCOP - - - - - - - - - - - - - - - - -<br />

Ohio State Univ 1 - - - - - - - - - - - - - - - -<br />

Oklahoma, Univ of - - - - - - - - - - - - - - - - -<br />

Oregon Hlth Sci Univ 5 - - - - 11 - - 3 - - - 22 1 - - -<br />

Orocovis Med Ctr - - - - - - - - - - - - - - - - -<br />

Ottawa General Hosp - - - - - - - - - - - - - - - - -<br />

Our Lady, Bellefonte - - - - - - - - - - - - - - - - -<br />

Ozarks CCOP - - - - - - - - - - - - - - - - -<br />

Ozarks Reg CCOP 3 - - 2 - - - - - - - - - 10 1 - -<br />

Pittsburgh Ca Inst - - - - - - - - - - - - - - - - -<br />

Princess Margaret - - - - - - - - - - - - - - - - -<br />

Prostate Cancer Ctr - - - - - - - - - - - - - - - - -<br />

Providence Hosp - - - - - - - - - - - - 9 4 1 - -<br />

Puget Sound 6 2 - - - 10 3 - - - - - 58 16 3 - -<br />

Queens Hospital Ctr - - - - - - - - - - - - - - - - -<br />

Regional CC-Waukesha - - - - - - - - - - - - - - - - -<br />

Regional Cancer Ctr - - - - - - - - - - - - - - - - -<br />

Rochester, Univ of 1 1 - 1 - - - - - - - 3 9 - 1 - -<br />

Roswell Park - - - - - - - - - - - - - - - - -<br />

Rush Univ Med Ctr - - - - - - - - - - - - - - - - -<br />

SELECT Coord Center - - - - - - - - - - - - - - - - -<br />

SUNY Stony Brook - - - - - - - - - - - - - - - - -<br />

SW Cancer & Res Ctr - - - - - - - - - - - - - - - - -<br />

San Antonio, U of TX 6 - - 16 - - - - - - - 1 17 - - - -<br />

San Diego, U of CA - - - - - - - - - - - - - - - - -<br />

San Juan MBCCOP - - - - - - - - - - - - - - - - -<br />

Sanford Cancer Ctr - - - - - - - - - - - - - - - - -<br />

Santa Rosa Mem Hosp - - - - - - - - - - - - - - - - -<br />

Schiffler Cancer Ctr - - - - - - - - - - - - - - - - -<br />

Scott & White CCOP - - - - - - - - - - - - 13 - - - -<br />

Sentara Cancer Inst - - - - - - - - - - - - - - - - -<br />

Sierra Nevada Mem - - - - - - - - - - - - - - - - -<br />

So Calif, U of - - - 11 - 5 - - - - - - - 21 - 3 -<br />

Somerset Med Ctr - - - - - - - - - - - - - - - - -<br />

Southeast CCC CCOP 3 - - 3 - 4 1 - - - - 2 66 25 4 2 -<br />

Southern Nevada CCOP - - - - - - - - - - - 1 4 1 - - -<br />

St Francis Hospital - - - - - - - - - - - - - - - - -<br />

St Louis CCOP 1 - - 6 - 10 - - - - - - 38 12 6 - -<br />

St Louis University - - - 4 - - - - - - - - 9 - - - -<br />

St Luke's Mt State - - - - - - - - - - - - - - - - -<br />

SWOG • Leading Cancer Research. Together.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 63<br />

Cancer Control and Prevention Committees<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

Symptom Control & Quality of Life<br />

E1609 E2108 E2906 E3805 E3A06 MA32 N0733 PR11 R04 R0848 R1010 S0622 S0702 S0715 S0927 S1013 S1200<br />

St Vincent Hospital - - - - - - - - - - - - - - - - -<br />

Stanford University - - - - - - - - - - - - - - - - -<br />

Stormont-Vail Health - - - - - - - - - - - - - - - - -<br />

Summa Health System - - - - - - - - - - - - - - - - -<br />

Sunnybrook Hlth SC - - - - - - - - - - - - - - - - -<br />

Sutter Hlth CRG-East - - - - - - - - - - - - - - - - -<br />

Swedish Medical Ctr - - - - - - - - - - - - - - - - -<br />

Tennessee, U of - - - - - 3 - - 6 - - - 3 - - - -<br />

Thompson Ca Surv Ctr - - - - - - - - - - - - - - - - -<br />

Thunder Bay Reg HSC - - - - - - - - - - - - - - - - -<br />

Toledo CCOP - - - - - - - - - - - - - - - - -<br />

Trinitas Hospital - - - - - - - - - - - - - - - - -<br />

Tulane University - 1 - - - - - - - - - - - - - - -<br />

Tyler, U of TX - - - - - - - - - - - - - - - - -<br />

UAB Div of Prev Med - - - - - - - - - - - - - - - - -<br />

US Oncology - - - - - - - - - - - - - - - - -<br />

Upstate Carolina - - - - - 4 - - - - - 5 8 3 4 - -<br />

Utah, U of 6 - - - - 22 - - 3 - - - 51 - 4 - -<br />

VAMC Asheville - - - - - - - - - - - - - - - - -<br />

VAMC Boston - - - - - - - - - - - - - - - - -<br />

VAMC Cleveland - - - - - - - - - - - - - - - - -<br />

VAMC Dallas - - - - - - - - - - - - - - - - -<br />

VAMC Durham - - - - - - - - - - - - - - - - -<br />

VAMC Fargo - - - - - - - - - - - - - - - - -<br />

VAMC Gainesville - - - - - - - - - - - - - - - - -<br />

VAMC Hines - - - - - - - - - - - - - - - - -<br />

VAMC Houston - - - - - - - - - - - - - - - - -<br />

VAMC James A. Haley - - - - - - - - - - - - - - - - -<br />

VAMC Kansas City - - - - - - - - - - - - - - - - -<br />

VAMC Loma Linda - - - - - - - - - - - - - - - - -<br />

VAMC Long Beach - - - - - - - - - - - - - - - - -<br />

VAMC Louisville - - - - - - - - - - - - - - - - -<br />

VAMC McGuire - - - - - - - - - - - - - - - - -<br />

VAMC Minneapolis - - - - - - - - - - - - - - - - -<br />

VAMC New Jersey - - - - - - - - - - - - - - - - -<br />

VAMC Northport - - - - - - - - - - - - - - - - -<br />

VAMC Pittsburgh - - - - - - - - - - - - - - - - -<br />

VAMC Puget Sound - - - - - - - - - - - - - - - - -<br />

VAMC So Arizona - - - - - - - - - - - - - - - - -<br />

VAMC St Louis - - - - - - - - - - - - - - - - -<br />

VAMC Stratton - - - - - - - - - - - - - - - - -<br />

VAMC Syracuse - - - - - - - - - - - - - - - - -<br />

VAMC Tuscaloosa - - - - - - - - - - - - - - - - -<br />

VAMC Washington DC - - - - - - - - - - - - - - - - -<br />

VAMC Western NY - - - - - - - - - - - - - - - - -<br />

VCU Massey CC - - - - - - - - - - - - - - - - -<br />

Valley Hospital - - - - - - - - - - - - - - - - -<br />

SWOG • Leading Cancer Research. Together.


64 <strong>Fall</strong> <strong>2012</strong><br />

Cancer Control and Prevention Committees<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

Symptom Control & Quality of Life<br />

E1609 E2108 E2906 E3805 E3A06 MA32 N0733 PR11 R04 R0848 R1010 S0622 S0702 S0715 S0927 S1013 S1200<br />

Vancouver Hospital - - - - - - - - - - - - - - - - -<br />

Vanderbilt Univ - - - - - - - - - - - - - - - - -<br />

Vermont Cancer Ctr - - - - - - - - - - - - - - - - -<br />

Virginia Mason CCOP - - - 3 - 1 - 4 - - - 1 55 11 - - -<br />

WNY Urology Assoc - - - - - - - - - - - - - - - - -<br />

WVU-Morgantown - - - - - - - - - - - - - - - - -<br />

Wake Forest Univ - - - - - - - - - - - - - - - - -<br />

Walter Reed AMC - - - - - - - - - - - - - - - - -<br />

Washington Univ - - - - - - - - - - - - - - - - -<br />

Wayne State Univ 2 - - - - 7 - - 3 - - - 7 - - - -<br />

Wayne State/Karmanos - - - - - - - - - - - - - - - - -<br />

West Clinic - - - - - - - - - - - - - - - - -<br />

Western Reg CCOP - - - - - - - - - - - - - - - - -<br />

Wichita CCOP - - - - - 10 - - - - - - 156 29 8 1 -<br />

Wilford Hall Med Ctr - - - - - - - - - - - - - - - - -<br />

William Beau Hosp - - - - - - - - - - - - - - - - -<br />

Wisconsin, Univ of - - - - - - - - - - - - - - - - -<br />

Yale University - - - - - - - - - - - - - - - - -<br />

York Cancer Center - - - - - - - - - - - - - - - - -<br />

ACOSOG - - - - - - - - - - - - - - - - -<br />

ANZ BCTG/ IBCSG - - - - - - - - - - - - - - - - -<br />

CALGB - - - - - - - - - - - - 135 - - - -<br />

ECOG - - - - - - - - - - - - 154 - - - -<br />

FSS/ IBCSG - - - - - - - - - - - - - - - - -<br />

GOG - - - - - - - - - - - - - - - - -<br />

NCCTG - - - - - - - - - - - - 188 - - - -<br />

NCIC - - - - - - - - - - - - - - - - -<br />

NSABP - - - - - - - - - - - - 9 - - - -<br />

RTOG - - - - - - - - - - - - 3 - - - -<br />

Total 121 9 2 149 7 473 7 8 49 8 1 85 2,009 437 117 11 1<br />

Note: Some studies may not be listed because they were either closed prior to July 1, 2011 or because they are currently active but have not had any accrual through September 6, <strong>2012</strong>.<br />

SWOG • Leading Cancer Research. Together.


EARLY THERAPEUTICS COMMITTEE<br />

SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 65<br />

Committee Leadership<br />

Chair:<br />

Executive Officer:<br />

Statisticians:<br />

Designates<br />

Clinical Research Associate:<br />

Data Coordinators:<br />

Nurse:<br />

Pharmacologist:<br />

Protocol Coordinator:<br />

Early Therapeutics Liaisons<br />

Breast Committee:<br />

Genitourinary Committee:<br />

Lung Committee:<br />

Lymphoma Committee:<br />

Melanoma Committee:<br />

Myeloma Committee:<br />

Thursday, October 18, <strong>2012</strong><br />

Room: Regency AB<br />

3:30 p.m. – 4:30 p.m.<br />

Introduction to Early Therapeutics<br />

Time/Location<br />

Agenda<br />

Razelle Kurzrock, M.D.<br />

Bruce Redman, D.O.<br />

Antje Hoering, Ph.D.<br />

Rachael Sexton, M.S.<br />

Corrine Turrell, C.C.R.P.<br />

Laura Kingsbury<br />

Christine McLeod<br />

Margaret Ward, R.N., B.S.N<br />

Siu-Fun Wong, Pharm.D.<br />

Sandi Fredette<br />

Fransisco Esteva, M.D.<br />

Neeraj Agarwal, M.D.<br />

Shirish M. Gadgeel, M.D.<br />

Daruka Mahadevan, M.D., Ph.D.<br />

TBD<br />

Frits van Rhee, M.D., Ph.D.<br />

Active Studies<br />

■■<br />

S0711, “A Phase I Trial of Dasatinib (BMS-354825) in Patients<br />

with Advanced Malignancies and Varying Levels of Liver<br />

Dysfunction.” Dr. Sarantopoulos. Activated: 10/15/08.<br />

Open Discussion<br />

Submitted Manuscripts<br />

■■<br />

S0528 Phase I study evaluating the combination of lapatinib<br />

and everolimus in patients with advanced cancers: SWOG study<br />

S0528. SM Gadgeel, D Lew, TW Synold, P LoRusso, V Chung,<br />

SD Christensen, DC Smith, L Kingsbury, A Hoering, R Kurzrock.<br />

Journal of Clinical Oncology, submitted 9/12.<br />

Early Therapeutics Committee<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

S0711<br />

City of Hope Med Ctr 1 -<br />

Davis, U of CA 1 -<br />

Henry Ford Hosp 10 -<br />

Kansas, U of 3 -<br />

Kentucky, U of - 5<br />

MUSC, Hollings CC - 2<br />

Michigan, U of - 10<br />

New Mexico MBCCOP - 5<br />

San Antonio, U of TX 38 1<br />

Scott & White CCOP 2 -<br />

So Calif, U of 8 -<br />

Wichita CCOP - 21<br />

Total 63 44<br />

S0916<br />

Note: Some studies may not be listed because they were either closed prior<br />

to July 1, 2011 or because they are currently active but have not had any<br />

accrual through September 6, <strong>2012</strong>.<br />

Publications<br />

The publications listed below are those that have been received in<br />

published, submitted or accepted form by the <strong>Group</strong> Chair’s Office<br />

since the Spring <strong>2012</strong> meeting agenda booklet publication list.<br />

Published/Accepted Manuscripts<br />

No publication information for this cycle.<br />

SWOG • Leading Cancer Research. Together.


66 <strong>Fall</strong> <strong>2012</strong><br />

GASTROINTESTINAL COMMITTEE<br />

Committee Leadership<br />

Chair:<br />

Vice-Chair:<br />

Executive Officer:<br />

Statisticians:<br />

Scientific Leadership<br />

Gastroesophageal:<br />

Pancreatic:<br />

Hepatobiliary:<br />

Colon:<br />

Rectal:<br />

Translational Medicine:<br />

Drug Development:<br />

Radiation Oncology:<br />

Designates<br />

Cancer Control Liaison:<br />

Clinical Research Associate:<br />

Data Coordinators:<br />

Nurses:<br />

Patient Advocates:<br />

Pharmaceutical Science:<br />

Protocol Coordinator:<br />

Charles D. Blanke, M.D.<br />

Heinz-Josef Lenz, M.D.<br />

Bruce Redman, D.O.<br />

Jacqueline K. Benedetti, Ph.D.<br />

Shannon McDonough, M.S.<br />

Cathryn Rankin, M.S.<br />

Syma Iqbal, M.D.<br />

Lawrence P. Leichman, M.D.<br />

Scott A. Hundahl, M.D. (Surgical<br />

representative)<br />

Philip A. Philip, M.D., Ph.D.<br />

Andrew M. Lowy, M.D. (Surgical<br />

representative)<br />

Anthony B. El-Khoueiry, M.D.<br />

Abby B. Siegel, M.D.<br />

Syed Ahmad, M.D. (Surgical<br />

representative)<br />

Philip J. Gold, M.D.<br />

Anthony F. Shields, M.D., Ph.D.<br />

Kevin G. Billingsley, M.D.<br />

(Surgical representative)<br />

Lisa A. Kachnic, M.D.<br />

Cathy Eng, M.D.<br />

Christopher L. Corless, M.D., Ph.D.<br />

Heinz-Josef Lenz, M.D.<br />

Ramesh Ramanathan, M.D.<br />

Sunil Sharma, M.D.<br />

Lisa A. Kachnic, M.D.<br />

Jason A. Zell, D.O.<br />

TBD<br />

Stephanie Edwards<br />

Christine McLeod<br />

Rodney Sutter<br />

Rita Kaul, R.N., B.S.N.<br />

Valerie A. Parks, R.N.<br />

Mortimer Brown, Ph.D.<br />

Porsha James, M.P.H.<br />

Holly O. Chan, Pharm.D.<br />

Kimberly Kaberle<br />

Time/Location<br />

Agenda<br />

Gastroesophageal<br />

Active Studies<br />

■■<br />

S1005, “A Phase II Study of MK-2206 (NSC-749607) as Second<br />

Line Therapy for Advanced Gastric and Gastroesophageal<br />

Junction Cancer.” Drs. Ramanathan and Kennecke. Activated:<br />

1/1/11.<br />

■■<br />

■■<br />

S1201, “A Randomized Phase II Pilot Study Prospectively<br />

Assigning Treatment for Patients Based on ERCC1 (Excision<br />

Repair Cross-Complementing 1) for Advanced/Metastatic<br />

Esophageal, Gastric or Gastroesophageal Junction (GEJ)<br />

Cancer.” Drs. Iqbal and Lenz. Activated: 2/8/12.<br />

CTSU/RTOG 1010, “A Phase II Trial Evaluating the Addition of<br />

Trastuzumab to Trimodality Treatment of HER2-Overexpressing<br />

Esophageal Adenocarcinoma.” Dr. L. Leichman. Activated:<br />

9/1/11.<br />

Proposed<br />

■■<br />

S1302, “A Phase II Study of Trastuzumab and mFOLFOX6<br />

as First Line Therapy of HER2-positive Advanced Gastric or<br />

Gastroesophageal Cancer.” Dr. Lenz.<br />

Pancreatic<br />

Active Studies<br />

■■<br />

S1115, “Randomized Phase II Clinical Trial of AZD-6244 (NSC-<br />

741078) and MK-2206 (NSC-749607) vs mFOLFOX in Patients<br />

with Metastatic Pancreatic Cancer After Prior Chemotherapy.”<br />

Drs. Chung and Philip. Activated: 8/15/12.<br />

■■<br />

■■<br />

CTSU/C80701, “Randomized Phase II Study of Everolimus Alone<br />

Versus Everolimus Plus Bevacizumab in Patients with Locally<br />

Advanced or Metastatic Pancreatic Neuroendocrine Tumors.” Dr.<br />

Wolin. Activated: 3/1/12.<br />

CTSU/RTOG 0848, “A Phase III Trial Evaluating Both Erlotinib<br />

and Chemoradiation as Adjuvant Treatment for Patients with<br />

Resected Head of Pancreas Adenocarcinoma.” Dr. Philip.<br />

Activated: 12/15/09.<br />

Friday, October 19, <strong>2012</strong><br />

Room: Crystal A Ballroom<br />

5:00 p.m. – 7:00 p.m.<br />

SWOG • Leading Cancer Research. Together.


GASTROINTESTINAL COMMITTEE<br />

SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 67<br />

Hepatobiliary<br />

Active Studies<br />

■■<br />

CTSU/C80802, “Phase III Randomized Study of Sorafenib<br />

Plus Doxorubicin Versus Sorafenib in Patients with Advanced<br />

Hepatocellular Carcinoma (HCC).” Activated: 6/1/11.<br />

■■<br />

CTSU/E1208, “A Phase III Randomized, Double-Blind Trial of<br />

Chemoembolization with or without Sorafenib in Unresectable<br />

Hepatocellular Carcinoma (HCC) in Patients with and without<br />

Vascular Invasion.” Dr. El-Khoueiry. Activated: 7/15/10.<br />

Closed Studies<br />

■■<br />

S0809, “A Phase II Trial of Adjuvant Capecitabine / Gemcitabine<br />

Chemotherapy Followed by Concurrent Capecitabine and<br />

Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC).” Drs.<br />

Ben-Josef, Zalupski, Lowy and Corless. Activated: 12/1/08;<br />

Closed: 10/1/12.<br />

Proposed Studies<br />

■■<br />

S1214, “A Randomized Open-Label Multi-Institution Phase II<br />

Study of Cabozantinib (NSC-761968) + Best Supportive Care<br />

(BSC) Compared to BSC + Placebo in the Second-Line Treatment<br />

of Patients with Advanced Hepatocellular Carcinoma (HCC).”<br />

Drs. El-Khoueiry and Thomas.<br />

■■<br />

S1218, “Randomized Phase II Trial of Single Agent MEK Inhibitor<br />

GSK11200212 vs. 5-Fluorouracil or Capecitabine in Refractory<br />

Advanced Biliary Cancer.” Dr. Kim.<br />

Colon<br />

Active Studies<br />

■■<br />

CTSU/C80702, “A Phase III Trial of 6 versus 12 Treatments<br />

of Adjuvant FOLFOX plus Celecoxib or Placebo for Patients<br />

with Resected Stage III Colon Cancer.” Dr. Shields. Activated:<br />

8/15/10.<br />

Proposed Studies<br />

■■<br />

S0820, “A Double Blind Placebo-Controlled Trial of Eflornithine<br />

and Sulindac to Prevent Recurrence of High Risk Adenomas and<br />

Second Primary Colorectal Cancers in Patients with Stage 0-III<br />

Colon Cancer, Phase III.” Dr. Zell.<br />

■■<br />

S-C80405-A, “Analysis of EGFR and ERCC1 Markers and<br />

Progression-Free Survival in Patients with Advanced Colorectal<br />

Cancer Enrolled on C80405.” Drs. Shields and Lenz.<br />

Rectal<br />

Active Studies<br />

■■<br />

S0713, “A Phase II Study of Oxaliplatin, Capecitabine,<br />

Cetuximab and Radiation in Pre-Operative Therapy of Rectal<br />

Cancer.” Drs. G. Leichman, Smalley, Billingsley and Lenz.<br />

Activated: 2/1/09.<br />

■■<br />

CTSU/N1048, “A Phase II/III Trial of Neoadjuvant FOLFOX with<br />

Selective Use of Combined Modality Chemoradiation versus<br />

Preoperative Combined Modality Chemoradiation for Locally<br />

Advanced Rectal Cancer Patients Undergoing Low Anterior<br />

Resection with Total Mesorectal Excision.” Dr. Eng. Activated:<br />

4/15/12.<br />

Other<br />

Active Studies<br />

■■<br />

S1013, “A Phase II Prospective Study of Epidermal Growth<br />

Facto Receptor (Her01/EGFR) Inhibitor-Induced Dermatologic<br />

Toxicity: Validation of the Functional Assessment of Cancer<br />

Therapy – EGFRI 18 (FACT-EGFRI 18) Questionnaire for EGFRI-<br />

Induced Skin Toxicities.” Drs. Wong, Moinpour, and Wade.<br />

Activated: 11/15/11.<br />

Closed Studies<br />

■■<br />

S0518, “Phase III Prospective Randomized Comparison of Depot<br />

Octreotide Plus Interferon Alpha Versus Depot Octreotide Plus<br />

Bevacizumab (NSC #704865) in Advanced, Poor Prognosis<br />

Carcinoid Patients.” Drs. Yao, Kvols and Moran. Activated:<br />

12/1/07; Closed: 9/1/12.<br />

Correlative Studies<br />

■■<br />

S0205A-ICSC, “Predictive and Prognostic Value of Tumor<br />

K-ras Mutation Status, Amphiregulin and Epiregulin and Gene<br />

Expression Levels and Germline Polymorphisms Involved in the<br />

EGFR and Gemcitabine Pathway in Advanced Pancreas Cancer:<br />

A Pilot Study of Tissues from Southwest Oncology <strong>Group</strong> Study<br />

S0205.” Dr. Lenz.<br />

Proposed Studies<br />

■ ■ “A Randomized Phase II International Study Assessing Adjuvant<br />

Standard and High-Dose Imatinib Mesylate Treatment in Fully<br />

Resected Intermediate and High-Risk GIST Patients with KIT<br />

Exon 9 Mutations.” Dr. Blanke.<br />

SWOG • Leading Cancer Research. Together.


68 <strong>Fall</strong> <strong>2012</strong><br />

GASTROINTESTINAL COMMITTEE<br />

■■<br />

■ ■<br />

■■<br />

■■<br />

■■<br />

Pilot esophageal study assessing treatment based on ERCC-1<br />

data. Dr. L. Leichman.<br />

“A Phase II Randomized Study of FOLFIRINOX + Pegylate<br />

Recombinant Human Hyaluronidase (PEGPH20) versus<br />

FOLFIRINOX Alone in Patients with Metastatic Pancreatic<br />

Adenocarcinoma”. Dr. Ramanathan.<br />

Borderline unresectable locally advanced pancreas. Drs. Esnaola<br />

and Ahmad.<br />

Phase II NCCTG Cholangiocarcinoma: Concept for metatstatic<br />

disease involving IMC112 and PARP inhibitor.<br />

Randomized Phase II Study Comparing Dual BRAF and PI3k<br />

Inhibition to Standard of Care Chemotherapy in BRAF Mutant<br />

Metastatic Colorectal Cancer. Dr. Kopetz.<br />

■■<br />

■■<br />

R9704 Failure to adhere to protocol specified radiation<br />

therapy guidelines was associated with decreased survival in<br />

RTOG 9704 - a phase III trial of adjuvant chemotherapy and<br />

chemoradiotherapy for patients with resected adenocarcinoma<br />

of the pancreas. RA Abrams, KA Winter, WF Regine, H Safran,<br />

JP Hoffman, R Lustig, AA Konski, AB Benson, JS Macdonald, TA<br />

Rich, CG Willett. International Journal of Radiation Oncology,<br />

Biology & Physics, 82(2):809-816, <strong>2012</strong>. http://www.ncbi.nlm.<br />

nih.gov/pubmed/21277694<br />

R9704 Five year results of US Intergroup/RTOG 9704 with<br />

postoperative CA 19-9 < 90 U/mL and comparison to the<br />

CONKO-001 trial. AC Berger, K Winter, JP Hoffman, WF Regine,<br />

RA Abrams, H Safran, GM Freedman, AB Benson, J Macdonald,<br />

CG Willett. International Journal of Radiation Oncology, Biology<br />

& Physics <strong>2012</strong> June 9 [Epub ahead of print]. http://www.ncbi.<br />

nlm.nih.gov/pubmed/22682806<br />

■■<br />

A Randomized Phase II Study Comparing The Novel MEK<br />

Inhibitor TAK-733 to Standard of Care Chemotherapy in Patients<br />

with KRAS Mutant, PI3K Wild-type Metastatic Colorectal<br />

Cancer. Dr. Lieu.<br />

Publications<br />

Submitted Manuscripts<br />

■■<br />

S0030 Higher AUC and reduced capecitabine clearance in elderly<br />

patients with advanced colo- rectal cancer (SWOG 0030). S<br />

Louie, B Ely, H Lenz, K Albain, C Gotay, D Coleman, D Raghavan,<br />

A Shields, P Gold, CD Blanke. British Journal of Cancer, under<br />

review 8/12<br />

The publications listed below are those that have been received in<br />

published, submitted or accepted form by the <strong>Group</strong> Chair’s Office<br />

since the Spring <strong>2012</strong> meeting agenda booklet publication list.<br />

Published/Accepted Manuscripts<br />

■■<br />

S0414 Cetuximab plus cisplatin, irinotecan, and thoracic<br />

radiotherapy as definitive treatment for locally advanced,<br />

unresectable esophageal cancer: a phase II study of the SWOG<br />

(S0414). M Tomblyn, B Goldman, C Thomas, J Benedetti, H<br />

Lenz, V Mehta, T Beeker, P Gold, J Abbruzzese, C Blanke.<br />

Journal of Thoracic Oncology 7(5):906-992, <strong>2012</strong>. http://www.<br />

ncbi.nlm.nih.gov/pubmed/22481235<br />

■■<br />

S9304 SWOG S9304 phase III intergroup trial’s<br />

pharmacogenetic analysis: association of polymorphisms with<br />

survival and toxicity in stage II/III rectal cancer patients treated<br />

with 5-fluorouracil and pelvic radiation. P Bohanes, CJ Rankin,<br />

CD Blanke, T Winder, CM Ulrich, SR Smalley, K Danenberg, KW<br />

Makar, W Zhang, JK Benedetti, H-J Lenz. Journal of Clinical<br />

Oncology, submitted 9/12<br />

■■<br />

S9008 Updated analysis of SWOG-directed intergroup study<br />

0116: a phase III trial of adjuvant radiochemotherapy versus<br />

observation following curative gastric cancer resection<br />

(CALGB-9195; ECOG-6290; NCCTG-90-41-51; RTOG 9018 and<br />

SWOG 9008. S Smalley, J Benedetti, D Haller, S Hundahl, N<br />

Estes, J Ajani, L Gunderson, B Goldman, J Martenson, J Jessup,<br />

G Stemmermann, C Blanke, J Macdonald. Journal of Clinical<br />

Oncology 30(19):2327-2333, <strong>2012</strong>. http://www.ncbi.nlm.nih.<br />

gov/pubmed/22585691<br />

SWOG • Leading Cancer Research. Together.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 69<br />

Gastrointestinal Committee<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

C80405<br />

C80701<br />

C80702<br />

C80802<br />

E1208<br />

E5202<br />

R04<br />

R0848<br />

R1010<br />

S0518<br />

S0600<br />

S0713<br />

S0727<br />

S0809<br />

S0941<br />

S1005<br />

S1201<br />

Arizona, U of - - - - - - - - - - - 1 - - 1 - -<br />

Arkansas, U of 9 - 1 1 11 12 - - - 3 - - 1 1 4 3 -<br />

Atlanta Reg CCOP 30 - - - - 43 - - - - - - 2 2 - - -<br />

BC Cancer Agency - - - - - - - - - - - - - - - 3 -<br />

Bay Area CCOP - - - - - - - - - - - - 1 - - - -<br />

Baylor College 4 - 5 - - 3 - - - - - 5 2 - - 2 -<br />

Beaumont CCOP 10 1 - - - 7 - - - - - - 1 - - - -<br />

Boston MC MBCCOP 3 - 1 2 - - - - - 1 - - 1 3 1 - -<br />

Boston Univ Med Ctr 3 - - - - - - - - - 1 - 7 - - - -<br />

Brooke Army Med Ctr 8 - 1 - - 18 4 - - - - - 1 - - - -<br />

Cedars-Sinai Med Ctr - 4 - - - - - - - 22 - - - - - - -<br />

Central IL CCOP 17 - 6 - - - - - 1 10 2 11 8 - 2 - -<br />

Cincinnati MC, U of - - - - 2 - - - - 8 - - - 2 - 2 -<br />

City of Hope Med Ctr 26 - 1 - - - - - - - 3 - 5 - - - -<br />

Cleveland Clinic OH 11 - 5 - - 4 - - - 1 - - - - - - -<br />

Colorado, U of 6 - 4 - 2 16 - - - 5 - - 4 1 - 1 -<br />

Columbia River CCOP 7 - - - - 2 - - - 6 - - - 4 - - -<br />

Columbia University 1 - 1 - 1 9 4 1 - 4 - 3 - - - - -<br />

Columbus CCOP 13 - 4 1 - - - - - 4 4 - - - - - -<br />

Davis, U of CA 51 - 8 - - 6 3 - - 9 1 1 6 1 9 - -<br />

Dayton CCOP 8 - - - - 2 - - - - 3 4 - 1 1 - 1<br />

Galveston, U of TX 13 - - - 2 - - - - - - - - - - - -<br />

Grand Rapids CCOP - - - - - 5 - - - - 1 1 8 - - 3 -<br />

Greenville CCOP - - - - - 28 - 1 - 5 - - - - - - -<br />

Gulf Coast MBCCOP - - - - - 1 - - - - - 1 4 - - - -<br />

H Lee Moffitt CC 11 - 1 - - 12 6 - - 22 - - 4 - - - -<br />

Harrington CC 3 - - - - 6 3 - - 1 - - - - - - -<br />

Hawaii MBCCOP, U of 30 - 8 - - 15 - - - - - - - - 1 - -<br />

Henry Ford Hosp - - - - - - - - - - - 1 - - - - -<br />

Irvine, U of CA 8 - 8 - - 11 1 1 - - 3 - 1 1 3 4 -<br />

KaiserPermanenteNCAL 11 - 37 2 - - - - - 3 - - - - - - -<br />

Kansas City CCOP - - - - 1 - - - - - - - 14 - 2 - -<br />

Kansas, U of 37 - 15 - 2 12 11 1 - 5 - 4 - 2 - 3 -<br />

Kentucky, U of 2 - 1 - - - - - - - - - - - - - -<br />

LSU-New Orleans CCOP 14 - 3 - - - - - - 1 - - - - - - -<br />

LSU-Shreveport 1 - - - - - - - - - - - - - - - -<br />

LSU-Shreveport CCOP 6 - 1 - - 4 2 - - - - - 1 - - - -<br />

Lahey Clinic Med Ctr - - - - 1 - - - - - - - - - - - -<br />

SWOG • Leading Cancer Research. Together.


70 <strong>Fall</strong> <strong>2012</strong><br />

Gastrointestinal Committee<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

C80405<br />

C80701<br />

C80702<br />

C80802<br />

E1208<br />

E5202<br />

R04<br />

R0848<br />

R1010<br />

S0518<br />

S0600<br />

S0713<br />

S0727<br />

S0809<br />

S0941<br />

S1005<br />

S1201<br />

Loyola University 5 - 4 - - 23 - 3 - - - - - 4 5 - -<br />

MD Anderson 18 - - - - 5 - - - 44 - - - - - - -<br />

MUSC, Hollings CC - - - - - - - - - - 1 - 8 4 2 - -<br />

Michigan CRC CCOP 1 - - - - - - - - 6 1 - - - 1 2 -<br />

Michigan, U of - - - - 3 1 - - - 8 - 2 5 6 - - -<br />

Mississippi, Univ of 11 - 1 - - 25 - - - 7 2 - - - 1 - -<br />

Montana CCOP 2 - 1 - - 5 - - - 3 3 - 1 - 1 2 -<br />

Nevada Cancer Inst 2 - - - - - - - - - - - - - - - -<br />

New Mexico MBCCOP - - - - - - - - - 14 - - 5 - - - -<br />

Northwest CCOP 13 - 1 1 - 8 - 1 - 2 - - - - - - -<br />

Oregon Hlth Sci Univ 7 - 3 - - 3 3 - - - - - 2 - - 4 -<br />

Ozarks Reg CCOP 7 - 5 - - 5 - - - 10 1 - - - - 4 -<br />

Providence Hosp 11 - 2 - 1 12 - - - - - - - - - - -<br />

Puget Sound 28 - 8 1 - 20 - - - 6 6 1 4 2 1 1 2<br />

Rochester, Univ of 15 - 3 - - 5 - - - 2 - 10 3 - - 5 1<br />

San Antonio, U of TX 20 - 1 - - 8 - - - - - - 1 - - - -<br />

Santa Rosa CCOP 1 - - - - 2 - - - - - - - - - - -<br />

Scott & White CCOP 7 - 1 - - - - - - - 2 - 2 - - - -<br />

So Calif, U of 65 - 14 - 5 30 - - - 9 9 11 9 3 4 - 2<br />

Southeast CCC CCOP - - - - - 20 - - - 7 - 7 10 1 - 2 1<br />

Southern Nevada CCOP - - - - - - - - - 3 - - - - - - -<br />

St Louis CCOP 1 - - - - 8 - - - 8 - - - - - - -<br />

St Louis University 4 - - - - 1 - - - 3 - - 3 - - 1 -<br />

Tennessee, U of 26 - - 3 - 5 6 - - 2 1 - - - - - -<br />

Tulane University - - - - - - - - - 1 - - - - - - -<br />

Upstate Carolina 8 - 1 - - 5 - - - - 1 1 - 1 - - -<br />

Utah, U of 18 - 3 - - 17 3 - - - - - 2 - - - -<br />

Virginia Mason CCOP 4 - - - - 1 - - - 1 - - - - - 1 -<br />

Wayne State Univ 30 - 10 - - 12 3 - - - 2 - 8 3 - - -<br />

Wichita CCOP - - 5 2 - - - - - 16 1 5 - 4 1 - -<br />

Yale University - - - 1 - - - - - - - - - - - - -<br />

ACOSOG - - - - - - - - - - - - - 3 - - -<br />

CALGB - - - - - - - - - 73 2 - - 15 - - -<br />

ECOG - - - - - - - - - 44 7 - - 15 - - 1<br />

NCCTG - - - - - - - - - 39 12 - - 5 - - 1<br />

NSABP - - - - - - - - - 4 3 - - 1 - - -<br />

RTOG - - - - - - - - - - - - - 19 - - -<br />

Total 647 5 174 14 31 437 49 8 1 422 72 69 134 104 40 43 9<br />

Note: Some studies may not be listed because they were either closed prior to July 1, 2011 or because they are currently active but have not had any accrual through September 6, <strong>2012</strong>.<br />

SWOG • Leading Cancer Research. Together.


GENITOURINARY COMMITTEE<br />

SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 71<br />

Committee Leadership<br />

Chair:<br />

Vice-Chair:<br />

Executive Officer:<br />

Statisticians:<br />

Scientific Leadership<br />

Translational Medicine:<br />

Radiation Oncology:<br />

Surgery:<br />

Medical Oncology:<br />

Pathology:<br />

Liaison to the SPORES:<br />

Early Therapeutics:<br />

Designates<br />

Clinical Research Associates:<br />

Cancer Control:<br />

Data Coordinators:<br />

Nurses:<br />

Patient Advocates:<br />

Pharmaceutical Science:<br />

Protocol Coordinator:<br />

Saturday, October 20, <strong>2012</strong><br />

Room: Regency A<br />

11:30 a.m. – 3:30 p.m.<br />

Time/Location<br />

Agenda<br />

Ian M. Thompson, Jr., M.D.<br />

Nicholas J. Vogelzang, M.D.<br />

Bruce Redman, D.O.<br />

Cathy M. Tangen, Dr.P.H.<br />

Hongli Li, M.S.<br />

David J. McConkey, Ph.D.<br />

David Raben, M.D.<br />

Daniel J. Culkin, M.D.<br />

Celestia S. Higano, M.D.<br />

M. Scott Lucia, M.D.<br />

Colin P.N. Dinney, M.D.<br />

Neeraj Agarwal, M.D.<br />

Debra W. Christie, M.B.A.<br />

Peter J. Van Veldhuizen, M.D.<br />

Jean Barce<br />

Austin Hamm<br />

Brian Zeller<br />

Deborah A. Halk, R.N.<br />

Rick Bangs (Bladder)<br />

Tony Crispino (Prostate)<br />

Gilland Dea, Pharm.D.<br />

Jessie Modlin, Pharm.D.<br />

Jennifer I. Scott<br />

Priority Studies<br />

■■<br />

S1216, “A Phase III Randomized Trial Comparing Androgen<br />

Deprivation Therapy + TAK-700 With Androgen Deprivation<br />

Therapy + Bicalutamide In Patients With Newly Diagnosed<br />

Metastatic Hormone Sensitive Prostate Cancer.”<br />

Bladder<br />

Organ Site Chairs: Drs. Daniel P. Petrylak (Advanced) and Seth P.<br />

Lerner (Local)<br />

Active Studies<br />

■■<br />

S1011, “A Phase III Surgical Trial to Evaluate the Benefit<br />

of a Standard Versus an Extended Pelvic Lymphadenectomy<br />

Performed at Time of Radical Cystectomy for Muscle Invasive<br />

Urothelial Cancer.” Drs. Lerner, Koppie, Alva and Svatek and R.<br />

Bangs. Activated: 8/1/11.<br />

■■<br />

■■<br />

CTSU/C90601, “A Randomized Double-Blinded, Phase III<br />

Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to<br />

Gemcitabine, Cisplatin, and Placebo in Patients with Advanced<br />

Transitional Cell Carcinoma.” Dr. Flaig. Activated: 8/15/09.<br />

CTSU/R0524, “A Phase I/II Trial of a Combination of Paclitaxel<br />

and Trastuzumab with Daily Irradiation or Paclitaxel Alone<br />

with Daily Irradiation Following Transurethral Surgery for Non-<br />

Cystectomy Candidates with Muscle-Invasive Bladder Cancer.”<br />

Dr. Swanson. Activated: 12/15/06.<br />

Closed Studies<br />

■■<br />

S0337, “A Phase III Blinded Study of Immediate Post-TURBT<br />

Instillation of Gemcitabine versus Saline in Patients with Newly<br />

Diagnosed or Occasionally Recurring Grade I/II Superficial<br />

Bladder Cancer.” Drs. Messing, Sahasrabudhe, Koppie, Wood<br />

and Mack. Activated: 7/15/07; Closed: 8/15/12.<br />

Prostate<br />

Organ Site Chairs: Drs. David I. Quinn (Advanced) and Martin E.<br />

Gleave and David Raben (Local)<br />

Active Studies<br />

■■<br />

S0925, “A Phase II Randomized Study of Androgen Deprivation<br />

Combined with IMC-A12 Versus Androgen Deprivation Alone<br />

for Patients with New Hormone-Sensitive Metastatic Prostate<br />

Cancer.” Drs. Yu and Higano. Activated: 12/15/10.<br />

■■<br />

■■<br />

S13XX, “COXEN (Coexpression Extrapolation) Directed<br />

Neoadjuvant Chemotherapy for Bladder Cancer.”<br />

Mims/Heath Transformative Renal Trial<br />

■■<br />

S1014, “Abiraterone Acetate Treatment for Prostate Cancer<br />

Patients with a PSA of More Than Four Following Initial<br />

Androgen Deprivation Therapy, Phase II.” Drs. Flaig and<br />

Hussain. Activated: 8/9/11.<br />

■■<br />

CTSU/C90203, “A Randomized Phase III Study of Neo-<br />

Adjuvant Docetaxel and Androgen Deprivation Prior to Radical<br />

SWOG • Leading Cancer Research. Together.


72 <strong>Fall</strong> <strong>2012</strong><br />

GENITOURINARY COMMITTEE<br />

■■<br />

Prostatectomy Versus Immediate Radical Prostatectomy in<br />

Patients with High-Risk, Clinically Localized Prostate Cancer.”<br />

Dr. Kim. Activated: 7/1/07.<br />

CTSU/E3805, “CHAARTED: ChemoHormonal Therapy versus<br />

Androgen Ablation Randomized Trial for Extensive Disease in<br />

Prostate Cancer.” Dr. Garcia. Activated: 9/1/08.<br />

Closed Studies<br />

■■<br />

CTSU/C90202, “A Randomized Double-Blind, Placebo-Controlled<br />

Phase III Study of Early versus Standard Zoledronic Acid to<br />

Prevent Skeletal Related Events in Men with Prostate Cancer<br />

Metastatic to Bone.” Dr. Bhoopalam. Activated: 8/1/04;<br />

Closed: 4/4/12.<br />

Proposed Studies<br />

■■<br />

S1216, “A Phase III Randomized Trial Comparing Androgen<br />

Deprivation Therapy + TAK-700 With Androgen Deprivation<br />

Therapy + Bicalutamide In Patients With Newly Diagnosed<br />

Metastatic Hormone Sensitive Prostate Cancer.” Dr. Agarwal.<br />

Renal Cell<br />

Organ Site Chairs: Drs. Primo N. Lara, Jr. (Advanced) and Edward M.<br />

Messing (Local)<br />

Active Studies<br />

■■<br />

S0931, “EVEREST: EVErolimus for Renal Cancer Ensuing<br />

Surgical Therapy, A Phase III Study.” Drs. Ryan, Heath, Lara,<br />

Palapattu and Mack. Activated: 4/1/11.<br />

■■<br />

S1107, “Parallel (Randomized) Phase II Evaluation of ARQ 197<br />

and ARQ 197 in Combination with Erlotinib in Papillary Renal Cell<br />

Carcinoma.” Drs. Twardowski and Lara. Activated: 8/20/12.<br />

Cancer Control<br />

Organ Site Chair: Dr. Peter J. Van Veldhuizen<br />

Active Studies<br />

■■<br />

S0702, “A Prospective Observational Multicenter Cohort Study<br />

to Asses the Incidence of Osteonecrosis of the Jaw (ONJ) in<br />

Cancer Patients with Bone Metastases Starting Zoledronic<br />

Acid Treatment.” Drs. Van Poznak, Gralow, Bagramian, and<br />

Schubert, and Lisa Hansen, R.N. Activated: 12/15/08.<br />

■■<br />

CTSU/C70807, “The Men’s Eating and Living (MEAL) Study: A<br />

Randomized Trial of Diet to Alter Disease Progression in Prostate<br />

Cancer Patients on Active Surveillance.” Dr. Van Veldhuizen.<br />

Activated: 6/1/11.<br />

Publications<br />

The publications listed below are those that have been received in<br />

published, submitted or accepted form by the <strong>Group</strong> Chair’s Office<br />

since the Spring <strong>2012</strong> meeting agenda booklet publication list.<br />

All PCPT and SELECT publications are listed under Cancer Control &<br />

Prevention Committees.<br />

Published/Accepted Manuscripts<br />

■■<br />

S8894/9346 Has survival prognosis of men with newly<br />

diagnosed M1 prostate cancer changed over time A SWOG<br />

phase III trial experience (S8894 & S9346). CM Tangen, MHA<br />

Hussain, CS Higano, MA Eisenberger, EJ Small, G Wilding, BJ<br />

Donnelly, DG McLeod, PF Schellhammer, ED Crawford, NJ<br />

Vogelzang, IJ Powell, IM Thompson. Journal of Urology <strong>2012</strong><br />

Aug 22 [Epub ahead of print]. http://www.ncbi.nlm.nih.gov/<br />

pubmed/22921015<br />

■■<br />

■■<br />

CTSU/C90802, “Randomized Phase III Trial Comparing<br />

Everolimus Versus Everolimus Plus Bevacizumab for Advanced<br />

Renal Cell Carcinoma Progressing After Treatment with Tyrosine<br />

Kinase Inhibitors.” Dr. Vaishampayan. Activated: 5/15/12.<br />

CTSU/E2810, “Randomized Double-Blind Phase III Study of<br />

Pazopanib vs. Placebo in Patients with Metastatic Renal<br />

Cell Carcinoma Who Have No Evidence of Disease Following<br />

Metastatectomy.” Dr. Pal. Activated: 9/1/12.<br />

SWOG • Leading Cancer Research. Together.<br />

■■<br />

NCIC PR7 Intermittent androgen suppression for rising PSA<br />

level after radiotherapy. J Crook, CJ O’Callaghan, G Duncan,<br />

DP Dearnaley, CS Higano, EM Horwitz, E Frymire, S Malone, J<br />

Chin, A Nabid, P Warde, T Corbett, S Angyalfi, SL Goldenberg,<br />

Gospodarowicz, F Saad, JP Logue, E Hall, PF Schellhammer, K<br />

Ding, L Klotz. New England Journal of Medicine, 367(10):895-<br />

903, <strong>2012</strong>. http://www.ncbi.nlm.nih.gov/pubmed/22931259<br />

Submitted Manuscripts<br />

■■<br />

S9917 Incidence of Prostate Cancer after HGPIN diagnosis:<br />

results from SWOG S9917. W Sakr, M Ray, CM Tangen, IM<br />

Thompson, EA Klein, K Kasza, L Minasian, H Parnes, DP Wood,<br />

JR Marshall. Journal of Clinical Oncology, submitted 9/12.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 73<br />

Genitourinary Committee<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

C70807<br />

C90202<br />

C90203<br />

C90601<br />

C90802<br />

E2804<br />

E2805<br />

E3805<br />

MDA3410<br />

Arizona, U of - - - - - - 5 - - - - - - - - -<br />

Arkansas, U of - 5 - 3 1 3 11 1 1 - - 4 4 2 - 1<br />

Atlanta Reg CCOP 1 - - 2 - - 20 - - - - - - 6 - -<br />

BC Cancer Agency - - - - - - - - - - - - 6 - - -<br />

Baylor College - 29 - 2 - 1 4 - - - - 5 - - 7 -<br />

Baylor College-UCOP - - - - - - 13 - - - - 36 - - - -<br />

Beaumont CCOP 4 - - - - - 8 - - 1 - - - - - -<br />

Boston MC MBCCOP - - - - - - - 1 - - - - - - - -<br />

Boston Univ Med Ctr - - - - - - - 1 - - - - - - - -<br />

Brooke Army Med Ctr - - 3 - - - 11 - - - - 22 - - - -<br />

Cedars-Sinai Med Ctr 1 - - - - - - - - - - 9 1 - - -<br />

Central IL CCOP - - - 1 - - - - - - - - 3 8 - -<br />

Cincinnati MC, U of - 1 - - - - 5 - - - - - - - - -<br />

City of Hope Med Ctr - - 10 - - - 9 - - - - - 14 5 - -<br />

Cleveland Clinic OH 1 - - 3 - 1 24 45 - - - 1 - - 1 -<br />

Colorado, U of 1 1 12 8 - - 12 11 - 3 - 21 8 6 - -<br />

Columbia River CCOP - - - - - - 1 - - - - - - - - -<br />

Columbia University - - - 3 - 1 12 5 - - - 8 - 3 - -<br />

Columbus CCOP - - - 1 - - - - - - - - - - - -<br />

Davis, U of CA - - 13 2 - 1 28 10 3 - - 39 4 12 - -<br />

Dayton CCOP - - - - - - 2 - - - - - 5 3 - -<br />

E Virginia UCOP - 1 - - - - 9 - - - - - - - - -<br />

Galveston, U of TX - - - - - - - - 1 - - - - 1 - -<br />

Grand Rapids CCOP - - - - - 4 14 - - - - - 1 3 - -<br />

Greenville CCOP - - - - - - 5 - - - - - - - - -<br />

Gulf Coast MBCCOP - - - - - - 1 1 - - - - - 1 - -<br />

H Lee Moffitt CC - 8 2 - - - 52 - 1 - - - 6 - - -<br />

Hawaii MBCCOP, U of - 2 - - - - 3 - - - - - 1 - - -<br />

Henry Ford Hosp - 1 1 2 - - 3 - - - - 7 3 3 - -<br />

Irvine, U of CA - - - - - 1 8 - - - - - - 1 - -<br />

KaiserPermanenteNCAL - - - - 1 - 9 - - - - - - 1 - -<br />

Kansas City CCOP - - - - - - 7 - - - - - - 2 - -<br />

Kansas, U of 2 4 11 1 - 2 19 2 - - 3 22 2 3 - -<br />

Kentucky, U of 1 - - 4 - - 3 8 - - - - - - - -<br />

LSU-New Orleans CCOP 1 - 2 - - - - - - - - - - - - -<br />

LSU-Shreveport CCOP - 2 1 - - - 3 - - - - 20 - 1 - -<br />

Loyola University - 14 11 - - - 10 6 3 - - 7 3 8 1 -<br />

MD Anderson - - 3 - - - 59 - - - - 17 - - 5 -<br />

PR11<br />

R0524<br />

S0337<br />

S0925<br />

S0931<br />

S1011<br />

S1014<br />

SWOG • Leading Cancer Research. Together.


74 <strong>Fall</strong> <strong>2012</strong><br />

Genitourinary Committee<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

C70807<br />

C90202<br />

C90203<br />

C90601<br />

C90802<br />

E2804<br />

E2805<br />

E3805<br />

MDA3410<br />

MUSC, Hollings CC - - - 3 - - 6 - - - - - 5 - - -<br />

Michigan CRC CCOP - - 2 1 - - - - - - - - 2 5 - -<br />

Michigan, U of - - - - - - 13 8 - - - 7 15 9 - -<br />

Michigan, U of-UCOP - - - - - - - - - - - 27 - - - -<br />

Mississippi, Univ of - - - 1 - 1 12 3 - - - - - 1 - -<br />

Montana CCOP - - - - - - 1 1 - - - - 1 1 - -<br />

New Mexico MBCCOP - - 1 - - - - - - - - - - - - -<br />

Northwest CCOP - 1 - - - - 6 - - - - - 3 - - -<br />

Oklahoma, U of-UCOP - - - - - - - - - - - 25 - - - -<br />

Oregon Hlth Sci Univ - - 1 - - - 11 - - - - 6 - 10 1 -<br />

Ozarks Reg CCOP - - - - - 2 2 2 - - - - - 2 - -<br />

Providence Hosp - - - - - 1 - - - - - - - - - -<br />

Puget Sound 1 4 1 2 - 4 30 - - - - 5 23 10 - -<br />

Rochester, Univ of - - 2 1 - 1 9 1 - - - 45 2 3 - -<br />

San Antonio, U of TX 3 - - - - 3 18 16 4 - - 53 - 1 7 1<br />

Scott & White CCOP - - - - - - - - - - - - - 1 - -<br />

So Calif, U of - 1 4 2 - 2 10 11 - - - 3 1 - 8 -<br />

Southeast CCC CCOP - - - - - 1 24 3 6 - - - - 10 - -<br />

Southern Nevada CCOP - - - - - - - - - - - - 10 2 - -<br />

St Louis CCOP - - - 2 - 3 16 6 - - - - - 3 - -<br />

St Louis University - - - - - - 2 4 - - - - - 1 - -<br />

Tennessee, U of - - - - - 11 7 - 3 - - - - 1 - -<br />

Upstate Carolina - - 1 1 - 1 5 - - - - - - - - -<br />

Urology Ctr of CO - - - - - - - - - - - 22 - - - -<br />

Utah, U of 10 3 - 1 - - 11 - - - - 5 26 7 - -<br />

Virginia Mason CCOP 5 - 10 - - - 14 3 - 4 - - - 2 - -<br />

Wayne State Univ - - 4 - - - 16 - - - - - 10 3 - -<br />

Wichita CCOP - - - 4 - - - - - - 2 - 4 3 - -<br />

CALGB - - - - - - - - - - - - - 13 22 -<br />

ECOG - - - - - - - - - - - - - 51 11 -<br />

NCCTG - - - - - - - - - - - - - 18 - -<br />

NSABP - - - - - - - - - - - - - 4 - -<br />

Total 31 77 95 50 2 44 583 149 22 8 5 416 163 230 63 2<br />

PR11<br />

R0524<br />

S0337<br />

S0925<br />

S0931<br />

S1011<br />

S1014<br />

Note: Some studies may not be listed because they were either closed prior to July 1, 2011 or because they are currently active but have not had any accrual through September 6, <strong>2012</strong>.<br />

Accrual to Cancer Control Studies is listed in the Cancer Control Sections.<br />

SWOG • Leading Cancer Research. Together.


GYNECOLOGIC COMMITTEE<br />

SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 75<br />

The Gynecologic Committee was formally closed as of<br />

September 1, 2010.<br />

Active Studies<br />

■■<br />

NCIC CTG OV.21, “A Phase II/III Study of Intraperitoneal (IP)<br />

Plus Intravenous (IV) Chemotherapy Versus IV Carboplatin Plus<br />

Paclitaxel in Patients with Epithelial Ovarian Cancer Optimally<br />

Debulked at Surgery Following Neoadjuvant Intravenous<br />

Chemotherapy.” Dr. Armstrong. Activated: 2/1/12.<br />

Closed Studies<br />

■■<br />

S0904, “Randomized Phase II Study of Docetaxel Followed by<br />

Vandetanib (ZD6474) vs. Docetaxel Plus Vandetanib in Patients<br />

with Persistent or Recurrent Epithelial Ovarian, <strong>Fall</strong>opian Tube,<br />

or Primary Peritoneal Carcinoma.” Drs. Coleman and Sood.<br />

Activated: 3/15/10; Closed 8/1/11.<br />

No publication information for this cycle.<br />

Gynecologic Committee<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

Arizona, U of 7<br />

Arkansas, U of 2<br />

Bay Area CCOP 3<br />

Colorado, U of 1<br />

Davis, U of CA 6<br />

Fox Chase Cancer Ctr 4<br />

Irvine, U of CA 1<br />

Loyola University 1<br />

MD Anderson 36<br />

Mississippi, Univ of 1<br />

Montana CCOP 3<br />

Ozarks Reg CCOP 19<br />

Puget Sound 10<br />

So Calif, U of 3<br />

Southeast CCC CCOP 4<br />

Southern Nevada CCOP 1<br />

St Louis CCOP 2<br />

Tulane University 1<br />

Univ of Chicago MC 5<br />

Univ of Maryland 2<br />

Wichita CCOP 19<br />

Total 131<br />

S0904<br />

Note: Some studies may not be listed because they were either closed prior<br />

to July 1, 2011 or because they are currently active but have not had any<br />

accrual through September 6, <strong>2012</strong>.<br />

SWOG • Leading Cancer Research. Together.


76 <strong>Fall</strong> <strong>2012</strong><br />

LEUKEMIA COMMITTEE<br />

Committee Leadership<br />

Chair:<br />

Vice-Chair:<br />

Executive Officer:<br />

Statisticians:<br />

Scientific Leadership<br />

Translational Medicine:<br />

Pathology:<br />

Cytogenetics Liaison:<br />

Designates<br />

Clinical Research Associates:<br />

Data Coordinators:<br />

Nurse:<br />

Patient Advocate:<br />

Pharmaceutical Science:<br />

Protocol Coordinator:<br />

Friday, October 19, <strong>2012</strong><br />

Room: Crystal C Ballroom<br />

3:00 p.m. – 7:00 p.m.<br />

Harry P. Erba, M.D., Ph.D.<br />

Alan F. List, M.D.<br />

Laurence H. Baker, D.O.<br />

Megan Othus, Ph.D.<br />

Shannon McDonough, M.S.<br />

Jerald P. Radich, M.D.<br />

David R. Head, M.D.<br />

Diane Roulston, Ph.D.<br />

Min Fang, M.D., Ph.D.<br />

Emilia G. Cantu<br />

Gaye L. Winakur, C.C.R.A.<br />

Jean Barce<br />

Laura Kingsbury<br />

Tracy Maher, C.C.R.P.<br />

Keisha C. Humphries, R.N., B.S.N.<br />

Michelle J. Worman, L.V.N.<br />

Holly O. Chan, Pharm.D.<br />

Sandi Fredette<br />

Time/Location<br />

Agenda<br />

Introduction<br />

Current Status of the Leukemia Committee<br />

Presentations<br />

From Genetic to Genomic Testing for Myeloid Malignancy - Aly<br />

Karsan, M.D., F.R.C.P.C., Integrative Oncology-Radiation Biology<br />

Unit, BC Cancer Agency.<br />

High-Risk Acute Promyelocytic Leukemia.” Dr. Lancet.<br />

Activated: 11/15/07.<br />

AML/MDS Studies<br />

Active Studies<br />

■■<br />

S0919, “A Phase II Study of Idarubicin and Ara-C in Combination<br />

with Pravastatin for Relapsed Acute Myelogenous Leukemia<br />

(AML).” Dr. Advani. Activated: 8/15/09.<br />

■■<br />

■■<br />

■■<br />

S1117, “A Randomized Phase II Study of Azacitidine in<br />

Combination with Lenalidomide (NSC-703813) vs. Azacitidine<br />

Alone vs. Azacitidine in Combination with Vorinostat (NSC-<br />

701852) for Higher-Risk Myelodysplastic Syndromes (MDS).”<br />

Dr. Sekeres. Activated: 3/1/12.<br />

CTSU/E2905, “Randomized Phase III Trial Comparing the<br />

Frequency of Major Erythroid Response (MER) to Treatment with<br />

Lenalidomide (Revlimid) Alone and in Combination with Epoetin<br />

Alpha (Procrit®) in Subjects with Low-or Intermediate-1 Risk<br />

MDS and Symptomatic Anemia.” Dr. Schiffer. Activated by<br />

ECOG: 1/29/09; Endorsed by SWOG: 2/15/09.<br />

CTSU/E2906, “Phase III Randomized Trial of Clofarabine as<br />

Induction and Post-Remission Therapy vs. Standard Daunorubicin<br />

& Cytarabine Induction and Intermediate Dose Cytarabine Post-<br />

Remission Therapy, Followed by Decitabine Maintenance vs.<br />

Observation in Newly-Diagnosed Acute Myeloid Leukemia in<br />

Older Adults (Age ≥ 60 Years.” Activated by ECOG: 12/28/10;<br />

Endorsed by SWOG: 7/20/12.<br />

Closed Studies<br />

■■<br />

S0703, “A Phase II Trial of Azacitidine (NSC-102816) Plus<br />

Gemtuzumab Ozogamicin as Induction and Post-Remission<br />

Therapy in Patients of Age 60 and Older with Previously<br />

Untreated Non-M3 Acute Myeloid Leukemia.” Dr. Nand.<br />

Activated: 12/1/08; Closed: 6/1/12.<br />

How Young Adult Research Can Be Embedded Into Studies<br />

Being Developed in the SWOG Leukemia Committee - Leonard<br />

Sender, M.D., Division Chief, Pediatric Oncology, University of<br />

California, Irvine.<br />

APL Studies<br />

Active Studies<br />

■■<br />

S0535, “A Phase II Study of ATRA, Arsenic Trioxide and<br />

Gemtuzumab Ozogamicin in Patients with Previously Untreated<br />

SWOG • Leading Cancer Research. Together.<br />

■■<br />

CTSU/C10603, “A Phase III Randomized, Double-Blind Study<br />

of Induction (Daunorubicin/Cytarabine) and Consolidation (High-<br />

Dose Cytarabine) Chemotherapy + Midostaurin (PKC 412)<br />

(IND#101261) or Placebo in Newly Diagnosed Patients < 60<br />

Years of Age with Flt3 Mutated Acute Myeloid Leukemia (AML).”<br />

Dr. Medeiros. Activated by CALGB: 4/1/08; Endorsed by SWOG:<br />

2/1/09; Closed: 10/15/11.


LEUKEMIA COMMITTEE<br />

SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 77<br />

Proposed Studies<br />

■■<br />

S1203, “A Randomized Phase III Study of Standard Cytarabine<br />

plus Daunomycin (7+3) Therapy versus Idarubicin with High<br />

Dose Cytarabine (IA) with or without Vorinostat in Younger<br />

Patients with Previously Untreated Acute Myeloid Leukemia<br />

(AML).” Dr. Garcia-Manero.<br />

ALL Studies<br />

Active Studies<br />

■■<br />

S0805, “Phase II Study of Combination of Hyper-CVAD and<br />

Dasatinib (NSC-732517) with or without allogenic stem cell<br />

transplant in Patients with Philadelphia (Ph) Chromosome<br />

Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia<br />

(ALL) (A BMT Study).” Dr. Ravandi. Activated: 9/1/09.<br />

■■<br />

CTSU/C10701, “A Phase II Study of Dasatinib (Sprycel®)<br />

(IND #73969, NSC #732517) as Primary Therapy Followed by<br />

Transplantation for Adults >= 50 Years with Newly Diagnosed<br />

Ph+ Acute Lymphoblastic Leukemia by CALGB, ECOG, SWOG<br />

and NCIC CTG(CALGB 10701).” Dr. Liedtke. Activated: 6/1/12.<br />

Closed Studies<br />

■■<br />

S0910, “A Phase II Study of Epratuzumab (NSC-716711) in<br />

Combination with Cytarabine and Clofarabine for Patients with<br />

Relapsed or Refractory PH-Negative Precursor B-cell Acute<br />

Lymphoblastic Leukemia (ALL).” Dr. Advani. Activated: 8/15/10;<br />

Closed 7/1/12.<br />

■■<br />

C10403, “An Intergroup Phase II Clinical Trial for Adolescents<br />

and Young Adults with Untreated Acute Lymphoblastic Leukemia<br />

(ALL).” Dr. Advani. Activated by CALGB: 11/15/07; Activated by<br />

SWOG: 1/15/08; Closed 9/14/12.<br />

CLL Studies<br />

Active Studies<br />

■■<br />

CTSU/E1908, “A Phase II Randomized Trial Comparing Standard<br />

and Low Dose Rituximab: Initial Treatment of Progressive<br />

Chronic Lymphocytic Leukemia in Elderly Patients Using<br />

Alemtuzumab and Rituximab.” Dr. Libby. Activated by ECOG:<br />

10/8/10; Endorsed by SWOG: 11/15/10.<br />

Closed Studies<br />

■■<br />

C10404, “A Genetic Risk-Stratified Randomized Phase II Study<br />

of Four Fludarabine/Antibody Combinations for Patients with<br />

Symptomatic, Previously Untreated Chronic Lymphocytic<br />

Leukemia.” Dr. Godwin. Activated by CALGB: 1/15/08;<br />

Activated by SWOG: 3/15/09; Closed: 8/17/12.<br />

Publications<br />

The publications listed below are those that have been received in<br />

published, submitted or accepted form by the <strong>Group</strong> Chair’s Office<br />

since the Spring <strong>2012</strong> meeting agenda booklet publication list.<br />

Published/Accepted Manuscripts<br />

■■<br />

S0325 A randomized trial of dasatinib 100 mg vs imatinib 400<br />

mg in newly diagnosed chronic phase chronic myeloid leukemia.<br />

JP Radich, KJ Kopecky, FR Appelbaum, S Kamel-Reid, W Stock,<br />

G Mainassy, E Paietta, M Wadleigh, R Larson, P Emmanuel, M<br />

Tallman, J Lipton, R Turner, B Druker. Blood <strong>2012</strong> Aug 22 [Epub<br />

ahead of print]. http://www.ncbi.nlm.nih.gov/pubmed/22915637<br />

■■<br />

■■<br />

■■<br />

■■<br />

S9031/S9033 DNMT3A-Mut independently predict poor<br />

outcome in older AML patients: a SWOG report. F Ostronoff, M<br />

Othus, P Ho, DE Geraghty, SH Petersdorf, J Anderson, J Godwin,<br />

C Willman, J Radich, F Appelbaum, K Kopecky, DL Stirewalt, S<br />

Meshinchi. Leukemia <strong>2012</strong> June 22 [Epub ahead of print]. http://<br />

www.ncbi.nlm.nih.gov/pubmed/22722750<br />

C9011 The impact of initial fludarabine therapy on<br />

transformation to richter’s syndrome or prolymphocytic leukemia<br />

in patients with chronic lymphocytics leukemia: analysis of<br />

an intergroup trial (CALGB 9011). M Solh, BL Peterson, F<br />

Appelbaum, M Tallman, A Belch, RA Larson, VA Morrison.<br />

Leukemia & Lymphoma <strong>2012</strong> Aug 17 [Epub ahead of print].<br />

http://www.ncbi.nlm.nih.gov/pubmed/22897733<br />

C9710 Treatment influenced associations of PML-RARa<br />

mutations, FLT3 mutations and additional chromosome<br />

abnormalities in relapse acute promyelocytic leukemia. RE<br />

Gallagher, BK Moser, J Racevskis, X Poire, CD Bloomfield, AJ<br />

Karroll, RP Ketterling, D Roulston, E Schachter-Tokarz, DC Zhou,<br />

IM Chen, R Harvey, G Koval, DA Sher, J Feusner, M Tallman,<br />

RA Larson, BL Powell, F Appelbaum, E Paietta, CL Willman, W<br />

Stock. Blood <strong>2012</strong> June 25 [Epub ahead of print]. http://www.<br />

ncbi.nlm.nih.gov/pubmed/22734072<br />

Multiple Studies Failed diagnostic cytogenetics is a poor<br />

prognostic feature in acute myeloid leukemia. B Medeiros, M<br />

Othus, M Fang, E Estey, F Appelbaum. Leukemia, accepted<br />

5/21/12.<br />

SWOG • Leading Cancer Research. Together.


78 <strong>Fall</strong> <strong>2012</strong><br />

LEUKEMIA COMMITTEE<br />

Submitted Manuscripts<br />

■■<br />

S0521 A phase III randomized trial (SWOG S0521) of<br />

maintenance vs. observation for patients with previously<br />

untreated low and intermediate risk acute promyelocytic<br />

leukemia (APL). SE Coutre, M Othus, B Powell, CL Willman, W<br />

Stock, E Paietta, D Levitan, M Wetzler, EC Attar, JK Altman,<br />

SD Gore, T Maher, KJ Kopecky, MS Tallman, RA Larson, FR<br />

Appelbaum. Blood, submitted 9/12.<br />

■■<br />

■■<br />

■■<br />

■■<br />

Multiple Studies Prognostic Significance of the French-<br />

American-British (FAB) Morphologic Subclassification of “Acute<br />

Myeloid Leukemia, Not Otherwise Specified” in the 2008 WHO<br />

Classification: Analysis of 5,848 Newly Diagnosed Patients from<br />

HOVON, MRC/NCRI, SWOG, and MD Anderson Cancer Center.<br />

R Walter, M Othus, A Burnett, B Lowenberg, H Kantarjian, G<br />

Ossenkoppele, R Hills, K van Montfort, F Ravandi, A Evans, S<br />

Pierce, F Appelbaum, E Estey. Journal of Clinical Oncology,<br />

submitted 8/8/12. [studies: S0106, S0112, S8600, S9031,<br />

S9034, S9333,S9500, S9617].<br />

Multiple Studies Age and karyotype changes in acute (nonpromyelocytic)<br />

myeloid leukemia. T Norwood, H Gundacker,<br />

ML Slovak, FR Appelbaum, C Willman. Genes, Chromsomes<br />

& Cancer, submitted 6/13/12 [studies: S8600, S9031,<br />

S9034,S9126, S9333, S9500,S9617, S9918, S0112, S0432]<br />

Multiple Studies Outcome of adolescents and young adults<br />

with acute myeloid leukemia treated on COG trials compared<br />

to CALGB and SWOG trials. W Woods, A Franklin, T Alonzo, R<br />

Gerbing, K Donohue, M Othus, J Horan, F Appelbaum, E Estey, C<br />

Bloomfield, R Larson. Blood, submitted 9/12. [studies: C19808,<br />

C8525, C9022, C9222, C9621, S0106, S8600, S9500]<br />

Multiple Studies Expression of novel IRF8 splice variants is<br />

associated with a significant decrease in relapse-free survival<br />

in adult AML patients. E Pogosova-Agadjanyan, K Kopecky,<br />

S Meshinchi, F Appelbaum, J Anderson, J Godwin, H Lee, A<br />

List, V Oehler, S Petersdorf, J Radich, C Willman, D Stirewalt.<br />

Leukemia, submitted 9/12. [studies S9031, S9126, S9333 and<br />

S9500]<br />

SWOG • Leading Cancer Research. Together.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 79<br />

Leukemia Committee<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

C10403<br />

C10404<br />

C10603<br />

E1905<br />

E1908<br />

Arkansas, U of - 3 - 1 - - - 2 - - - - - -<br />

Atlanta Reg CCOP - - 1 - - - - - - - - - - -<br />

Baylor College - - 1 - - - - - - - - 6 1 -<br />

Boston Univ Med Ctr - - 1 1 - - - - - - - - - -<br />

Central IL CCOP - - - - - - - - 1 6 - - - -<br />

Cincinnati MC, U of - - 1 - - - - - 1 - - - - -<br />

City of Hope Med Ctr 2 - - - - - - - - - 1 4 - -<br />

Cleveland Clinic OH 15 - - 1 - - - - 7 - - 3 11 5<br />

Colorado, U of - - - 1 - - - - 3 - - 2 1 -<br />

Columbia River CCOP - - - - - - - - - 9 - - - -<br />

Columbia University - - - - - 1 - - - - - - - -<br />

Columbus CCOP - - - - - - - - - 1 - - - -<br />

Davis, U of CA - 1 3 1 - 4 - - 2 4 1 - - -<br />

Grand Rapids CCOP - - - - - - - 1 - 2 - - - -<br />

Greenville CCOP - - - - - 3 - - - - - 1 - 2<br />

H Lee Moffitt CC - - 4 - - 7 - - 11 - - 2 4 -<br />

Hawaii MBCCOP, U of - - - - - - - - - - - - - 2<br />

Irvine, U of CA 3 - 3 - - - - - - - - - - -<br />

KaiserPermanenteNCAL - - - - - 5 - - - - - - - -<br />

Kansas City CCOP - - - 1 - 1 - - - 5 - - - -<br />

Kansas, U of 3 - - - - - - - - 4 1 - - 1<br />

Kentucky, U of 4 - 1 - - - 1 - - 21 2 - - -<br />

LSU-Shreveport CCOP - - 1 - - - - - - - - - - -<br />

Lahey Clinic Med Ctr - 1 - - - - - - - - - - - -<br />

Loyola University 1 1 3 - - - 1 1 - 28 2 1 3 -<br />

MD Anderson - - - - - - - - - - 5 - - -<br />

MUSC, Hollings CC 8 8 6 - - - - 2 - 6 1 1 - -<br />

Michigan CRC CCOP 1 - - - - - - - - 2 - - - -<br />

Michigan, U of 5 - - 1 - - - - 1 14 - - - -<br />

Mississippi, Univ of - - - 1 - - - - - 1 - 3 1 -<br />

Montana CCOP - 1 - 3 - 2 - - 1 1 - - - -<br />

New Mexico MBCCOP 2 3 - - - - - - - 6 - - 4 -<br />

Ozarks Reg CCOP - - - 1 - - - - - - - - - -<br />

Providence Hosp - - 2 - - - - - 2 - - - - -<br />

Puget Sound 2 - - - - - - 1 6 - 5 - 2 -<br />

E2905<br />

E2906<br />

S0535<br />

S0605<br />

S0703<br />

S0805<br />

S0910<br />

S0919<br />

S1117<br />

SWOG • Leading Cancer Research. Together.


80 <strong>Fall</strong> <strong>2012</strong><br />

Leukemia Committee<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

C10403<br />

C10404<br />

C10603<br />

E1905<br />

E1908<br />

Rochester, Univ of 3 6 1 2 - - - - 4 5 - 4 3 -<br />

San Antonio, U of TX - 2 - - - 2 - - - - - - - -<br />

Santa Rosa CCOP - - - 1 - - - - - - - - - -<br />

So Calif, U of - - - - - - - - - 1 - - - -<br />

Southeast CCC CCOP - - - 2 - 1 - - - 3 - - - -<br />

St Louis CCOP - 2 - 2 - - - - - - - - - -<br />

St Louis University - 2 - - - - - - - - - - - -<br />

Stanford University 25 - 7 - - - - 6 - 12 1 6 - -<br />

Tennessee, U of - - 2 4 1 - - - 1 - - - - -<br />

Upstate Carolina - - - - - - - - 1 - - - - -<br />

Utah, U of 3 - - - - 1 - 1 - - - 2 - -<br />

Wayne State Univ 4 - - - - 2 - - - 7 1 - - -<br />

Wichita CCOP 2 4 1 - - - - 2 - 4 - - 2 -<br />

CALGB - - - - - - - 34 - - 9 - - -<br />

ECOG - - - - - - - 15 - - 10 - - 1<br />

NCCTG - - - - - - - - - - - - - 1<br />

Total 83 34 38 23 1 29 2 65 41 142 39 35 32 12<br />

Note: Some studies may not be listed because they were either closed prior to July 1, 2011 or because they are currently active but have not had any accrual through September 6, <strong>2012</strong>.<br />

E2905<br />

E2906<br />

S0535<br />

S0605<br />

S0703<br />

S0805<br />

S0910<br />

S0919<br />

S1117<br />

SWOG • Leading Cancer Research. Together.


LUNG COMMITTEE<br />

SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 81<br />

Committee Leadership<br />

Chair:<br />

Vice-Chair:<br />

Executive Officer:<br />

Statisticians:<br />

Scientific Leadership<br />

Translational Medicine:<br />

Radiation Oncology:<br />

Surgery:<br />

Medical Oncology:<br />

Pathology:<br />

Developmental Therapeutics:<br />

Early Therapeutics:<br />

Designates<br />

Clinical Research Associate:<br />

Cancer Control Liaison:<br />

Community Affiliate:<br />

Data Coordinators:<br />

Nurses:<br />

Patient Advocate:<br />

Pharmaceutical Science:<br />

Protocol Coordinator:<br />

Saturday, October 20, <strong>2012</strong><br />

Room: Regency B<br />

11:30 a.m. – 3:30 p.m.<br />

Opening Remarks<br />

David R. Gandara, M.D.<br />

Stephen G. Swisher, M.D.<br />

Anne Schott, M.D.<br />

Mary Redman, Ph.D.<br />

James Moon, M.S.<br />

Philip C. Mack, Ph.D.<br />

Fred R. Hirsch, M.D., Ph.D.<br />

Laurie E. Gaspar, M.D.<br />

Stephen G. Swisher, M.D.<br />

Karen Kelly, M.D.<br />

Ignacio I. Wistuba, M.D.<br />

Roy S. Herbst, M.D., Ph.D.<br />

Shirish M. Gadgeel, M.D.<br />

Courtney L. Williamson, C.C.R.P.<br />

Gary E. Goodman, M.D.<br />

Paul J. Hesketh, M.D.<br />

Larry Kaye<br />

Brian Zeller<br />

Christine McLeod<br />

Vicki Green<br />

Kimberly M. Belzer, M.S., P.A.-C<br />

Rosalie Zablocki, R.N.<br />

Bonnie J. Addario<br />

Jorge G. Avila, Pharm.D.<br />

TBD<br />

Time/Location<br />

Agenda<br />

Translational Medicine Session - Dr. Mack<br />

Surgery Session - Dr. Swisher<br />

Scientific Session<br />

Dr. Lynch – “Optimal therapy for EGFR mutant NSCLC: Role of monoclonal<br />

antibodies and dual kinase inhibitors in overcoming resistance”<br />

Dr. Gadgeel – “MEK inhibition in the therapy of KRAS mutant<br />

NSCLC.”<br />

New Proposals<br />

■ ■ “Ipilimumab Plus EGFR Inhibitor for EGFR Mutated Non-Small<br />

Cell Lung Cancer.” Dr. Akerly.<br />

■ ■<br />

■ ■<br />

■ ■<br />

■■<br />

“Randomized Phase II Trial of Individualized Systemic Therapy in<br />

Stage III NSCLC.” Dr. Kalemkarian.<br />

“Implementation of Lung Cancer Screening.” Dr. Hesketh.<br />

“A Randomized Phase III Trial of Alisertib Versus Topotecan in<br />

Patients with Pretreated Small Cell Lung Cancer.” Dr. Liu.<br />

Dr. Ou<br />

Other<br />

■■<br />

E2810, “Randomized, Double-Blind Phase III Study of Pazopanib<br />

Vs. Placebo in Patients with Metastatic Renal Cell Carcinoma<br />

Who Have No Evidence of Disease Following Metastatectomy.”<br />

Dr. Pal.<br />

Active Studies<br />

■■<br />

S1013, “A Phase II Prospective Study of Epidermal Growth<br />

Factor Receptor (Her-1/EGFR) Inhibitor-Induced Dermatologic<br />

Toxicity: Validation of the Functional Assessment of Cancer<br />

Therapy – EGFRI 18 (FACT-EGFRI 18) Questionnaire for EGFRIinduced<br />

Skin Toxicities.” Dr. Wong. Activated: 11/15/11.<br />

■■<br />

■■<br />

■■<br />

■■<br />

S0905, “A Phase I / Randomized Phase II Study of Cediranib<br />

(NSC #732208) Versus Placebo in Combination with Cisplatin<br />

and Pemetrexed in Chemonaive Patients with Malignant Pleural<br />

Mesothelioma.” Drs. Tsao. Activated: 3/15/10, Phase I Closed:<br />

7/18/11; Phase II Activated: 9/15/11.<br />

S0819, “A Randomized, Phase III Study Comparing Carboplatin<br />

/ Paclitaxel or Carboplatin / Paclitaxel / Bevacizumab with or<br />

without Concurrent Cetuximab in Patients with Advanced Non-<br />

Small Cell Lung Cancer (NSCLC).” Drs. Herbst, Kim, Semrad,<br />

Gandara, Hirsch and Mack. Activated: 7/15/09.<br />

S0709, “A Phase II Selection Design of Pharmacodynamic<br />

Separation of Carboplatin / Paclitaxel / OSI-774 (Erlotinib; NSC-<br />

718781) or OSI-774 Alone in Advanced Non-Small Cell Lung<br />

Cancer (NSCLC) Patients with Performance Status 2 (PS-2)<br />

Selected by Serum Proteomics.” Drs. Lara, Hesketh, Mack and<br />

Hirsch. Activated: 12/1/08.<br />

S0702, “A Prospective Observational Multicenter Cohort Study<br />

to Assess the Incidence of Osteonecrosis of the Jaw (ONJ) in<br />

Cancer Patients with Bone Metastases Starting Zoledronic Acid<br />

SWOG • Leading Cancer Research. Together.


82 <strong>Fall</strong> <strong>2012</strong><br />

LUNG COMMITTEE<br />

■■<br />

■■<br />

■■<br />

■■<br />

Treatment.” Drs. Van Poznak, Gralow, Schubert and Bagramian,<br />

and Ms. Hansen. Activated: 12/15/08.<br />

CTSU/CALGB 140503, “A Phase III Randomized Trial of<br />

Lobectomy versus Sublobar Resection for Small (≤ 2 cm)<br />

Peripheral Non-Small Cell Lung Cancer.” Dr. Mitchell. Activated:<br />

1/15/08.<br />

CTSU/CALGB 30801, “A Randomized Phase III Double Blind<br />

Trial Evaluating Selective COX-2 Inhibibition in COX-2 Expressing<br />

Advanced Non-Small Cell Lung Cancer.” Dr. Reckamp.<br />

Activated: 2/15/10.<br />

CTSU/CALGB 30610, “Phase III Comparison of Thoracic<br />

Radiotherapy Regimens in Patients with Limited Small Cell Lung<br />

Cancer also Receiving Cisplatin and Etoposide.” Drs. Gaspar and<br />

Gadgeel. Activated: 4/1/08.<br />

CTSU/E1505, “A Phase III Randomized Trial of Adjuvant<br />

Chemotherapy with or without Bevacizumab for Patients with<br />

Completely Resected Stage IB (≥ 4 cm) – IIIA Non-Small Cell<br />

Lung Cancer (NSCLC).” Drs. Gandara and Vallieres. Activated:<br />

7/1/07.<br />

■■<br />

S0635, “A Phase II Trial of the Combination of OSI-774<br />

(Erlotinib; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-<br />

704865) in Stage IIIB and IV Bronchioloalveolar Carcinoma<br />

(BAC) and Adenocarcinoma with BAC Features (AdenoBAC).”<br />

Drs. West, Lau, Hirsch and Wozniak. Activated: 7/15/07; Closed:<br />

8/15/11.<br />

Proposed Studies<br />

■■<br />

S1206, “Dose Finding Followed by Phase II Randomized,<br />

Placebo-Controlled Study of Veliparib (ABT-888) Added<br />

to Chemoradiotherapy with Carboplatin and Paclitaxel for<br />

Unresectable Stage III Non-Small Cell Lung Cancer, (NCI Study<br />

Number 8811).” Drs. Argiris, Cristea and Chen.<br />

■■<br />

■■<br />

S1220, “A Phase II Selection Design Study of MK-2206, a Novel<br />

Akt Inhibitor, in Relapsed, Small Cell Lung Cancer Patients as<br />

Monotherapy or in Combination with Weekly Topotecan.” Drs.<br />

Kelly, Huang and Mack.<br />

S1300, “A Randomized Phase II Trial of Crizotinib Plus<br />

Pemetrexed Versus Pemetrexed Alone in Non-Squamous NSCLC<br />

at Acquired Resistance to Crizotinib Monotherapy.” Drs.<br />

Camidge, Li and Doeble.<br />

■■<br />

CTSU/N107C, “A Phase III Trial of Post-Surgical Stereotactic<br />

Radiosurgery (SRS) Compared with Whole Brain Radiotherapy<br />

(WBRT) for Resected Metastatic Brain Disease.” Dr. Gaspar.<br />

Activated: 12/1/2011.<br />

Closed Studies<br />

■■<br />

S0802, “A Randomized Phase II Trial of Weekly Topotecan with<br />

and without AVE0005 (Aflibercept; NSC-724770) in Patients<br />

with Platinum Treated Extensive Stage Small Cell Lung Cancer<br />

(E-SCLC).” Drs. Allen, Gadgeel, Kelly and Mack. Activated:<br />

5/15/09; Closed: 3/1/12.<br />

■■<br />

■■<br />

■■<br />

S0722, “A Phase II Trial of mTOR Inhibitor, Everolimus<br />

(RAD001), in Malignant Pleural Mesothelioma (MPM).” Drs. Ou,<br />

Garland and Mack. Activated: 12/1/08; Closed 9/15/11.<br />

S0720, “Phase II ERCC1 and RRM1-Based Adjuvant Therapy<br />

Trial in Patients with Stage I Non-Small Cell Lung Cancer<br />

(NSCLC).” Drs. Zinner, Calhoun, Kernstine, Williams and Mack.<br />

Activated: 11/15/08; Closed: 5/15/12.<br />

S0636, “A Phase II Trial of the Combination of OSI-774<br />

(Erlotinib; NSC-718781) and Bevacizumab (Rhumab VEGF;<br />

NSC-704865) in Never-Smokers with Stage IIIB and IV Primary<br />

NSCLC Adenocarcinomas.” Drs. West, Hirsch and Wozniak.<br />

Activated: 7/15/07; Closed: 9/1/10.<br />

■■<br />

S1301, “A Randomized, Phase II Selection Design Trial of<br />

GSK212 (Trametinib) with Docetaxel or with GSK2141795 in<br />

Patients with Progressive Kras Mutation Positive Non-Small<br />

Cell Lung Cancer (NSCLC) following at Least One Prior Systemic<br />

Therapy.” Dr. Gadgeel.<br />

Publications<br />

The publications listed below are those that have been received in<br />

published, submitted or accepted form by the <strong>Group</strong> Chair’s Office<br />

since the Spring <strong>2012</strong> meeting agenda booklet publication list.<br />

Published/Accepted Manuscripts<br />

■■<br />

S0819 Design of a phase III clinical trial with prospective<br />

biomarker validation: SWOG S0819. M Redman, J Crowley,<br />

R Herbst, F Hirsch, D Gandara. Clinical Cancer Research<br />

18(15):4004-4012, <strong>2012</strong>. http://www.ncbi.nlm.nih.gov/<br />

pubmed/22592956<br />

■■<br />

NCCTG/SWOG Multiple Studies Impact of disease progression<br />

date determination on progression free survival estimates in<br />

advanced lung cancer. Y Qi, A Ziegler, S Hillman, M Redman,<br />

S Schild, D Gandara, A Adjei, S Mandrekar. Cancer <strong>2012</strong><br />

Mar 20 [Epub ahead of print]. http://www.ncbi.nlm.nih.gov/<br />

pubmed/22434489<br />

SWOG • Leading Cancer Research. Together.


LUNG COMMITTEE<br />

SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 83<br />

Submitted Manuscripts<br />

■■<br />

S0526 SWOG phase II trial (S0526) of pemetrexed in patients<br />

with metastatic bronchioloalveolar carcinoma (BAC). DHM<br />

Lau, J Moon, AM Davies, R Sanborn, F Hirsch, W Franklin, J<br />

Ruzich, M Redman, DR Gandara. Clinical Lung Cancer, submitted<br />

8/15/12.<br />

■■<br />

S0536 Phase II trial of combination carboplatin, paclitaxel,<br />

cetuximab and bevacizumab followed by cetuximab and and<br />

bevacizumab in patients with advanced non-small cell lung<br />

cancer: SWOG S0356. ES Kim, J Moon, RS Herbst, M Redman,<br />

SR Dakhil, MR Velasco, FR Hirsch, PC Mack, K Kelly and DR<br />

Gandara. Journal of Clinical Oncology, submitted 8/15/12.<br />

SWOG • Leading Cancer Research. Together.


84 <strong>Fall</strong> <strong>2012</strong><br />

Lung Committee<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

C140503<br />

C30610<br />

C30801<br />

E1505<br />

Arizona, U of - - - - - - - - 5 1 10 -<br />

Arkansas, U of - 1 - 2 1 - 1 - - 3 4 -<br />

Atlanta Reg CCOP - - - 3 3 3 - - - 5 8 -<br />

Bay Area CCOP - - - 1 - - - - - - 1 -<br />

Baylor College - - - - - - - - - 1 4 -<br />

Beaumont CCOP - - - 7 - - - - - - - -<br />

Boston Univ Med Ctr - - - 2 - - - - - - - -<br />

Brooke Army Med Ctr - - - 2 - - - - - 1 - -<br />

Central IL CCOP - 5 - - 4 - 2 3 1 20 37 1<br />

Cincinnati MC, U of - - - 4 - - - 1 - 1 3 -<br />

City of Hope Med Ctr - - 2 - - - - 3 - 2 - -<br />

Cleveland Clinic OH - - - 4 - - - - - 1 - -<br />

Colorado, U of 2 - - 10 4 - - 2 3 4 14 -<br />

Columbia River CCOP - - - - - 3 - 4 3 1 - -<br />

Columbia University - - - 2 - - - - - 2 4 -<br />

Columbus CCOP - - - - 5 - - 2 1 1 5 -<br />

Davis, U of CA 4 7 1 17 8 12 10 8 - 11 61 -<br />

Dayton CCOP - - - 3 - - - 4 3 14 14 -<br />

Grand Rapids CCOP - - - 10 8 1 - 2 - 4 9 -<br />

Greenville CCOP - - - 12 - - - 1 - - 24 -<br />

Gulf Coast MBCCOP - - - 3 - - - - - 2 1 -<br />

H Lee Moffitt CC - - - 18 - 2 - 5 - - 10 -<br />

Harrington CC - - - 2 - - - - - - - -<br />

Hawaii MBCCOP, U of - - 2 3 - - - 7 - - 5 -<br />

Henry Ford Hosp - - - 4 4 1 - - - - 6 1<br />

INCan - - - - - - - - - - 2 -<br />

Irvine, U of CA - - - 5 - - - - 4 - 10 -<br />

KaiserPermanenteNCAL - 1 - 12 8 17 6 - - - - -<br />

Kansas City CCOP - - - 1 - - - - - - 15 -<br />

Kansas, U of - - - 12 5 3 10 - - 11 30 -<br />

Kentucky, U of - - - - 1 1 - - - 2 28 -<br />

LSU-New Orleans CCOP - - - - - - - - - 6 3 -<br />

LSU-Shreveport CCOP - - 1 - - - - - - - 5 -<br />

Lahey Clinic Med Ctr - - - 3 - - 1 - - 1 2 -<br />

Loyola University - - 1 3 1 2 - - - 4 11 -<br />

MD Anderson - - - - - - - - 14 - 9 28<br />

S0635<br />

S0636<br />

S0709<br />

S0720<br />

S0722<br />

S0802<br />

S0819<br />

S0905<br />

SWOG • Leading Cancer Research. Together.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 85<br />

Lung Committee<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

C140503<br />

C30610<br />

C30801<br />

E1505<br />

MUSC, Hollings CC - 1 - - 3 4 - - - - 5 -<br />

Michigan CRC CCOP - - - - 3 6 3 12 3 9 22 -<br />

Michigan, U of - 1 - 2 - - - 1 3 5 - 5<br />

Mississippi, Univ of - - 2 6 - 3 - 1 1 1 2 -<br />

Montana CCOP - - - 4 6 5 1 3 2 4 4 1<br />

Nevada Cancer Inst - - - - - - - - - - 3 -<br />

New Mexico MBCCOP - - - - - - - - 2 - - -<br />

Northwest CCOP - - - 5 - - - - - - 12 -<br />

Oregon Hlth Sci Univ - - - 4 - - - 3 - 2 5 -<br />

Ozarks Reg CCOP - - 1 2 - 3 2 2 - 4 - -<br />

Providence Hosp - 2 1 1 - - - 2 - - 1 -<br />

Puget Sound 5 - 1 9 3 14 - 3 1 1 9 2<br />

Rochester, Univ of - - - 6 5 - - - 2 4 9 -<br />

San Antonio, U of TX - 3 - 9 - - - - - 3 22 -<br />

Scott & White CCOP - - - - - - - 4 - 1 - -<br />

So Calif, U of - - - 5 - - 1 - - - 12 -<br />

Southeast CCC CCOP - - - 6 1 - 1 - 3 26 13 1<br />

Southern Nevada CCOP - - - - - - - - - 1 7 -<br />

St Louis CCOP - - - 5 - - - - - 2 6 -<br />

St Louis University - - - - - - - - 1 - - -<br />

Tennessee, U of 2 - - 6 - - - - - 4 5 -<br />

Tulane University - - - 1 - - - - - - - -<br />

Upstate Carolina - - - 4 1 1 - 2 - 4 7 -<br />

Utah, U of - - - 5 1 - 9 - - 5 18 -<br />

Virginia Mason CCOP - - - 1 - - - - - - 1 -<br />

Wayne State Univ - 1 - 11 - - - 3 9 5 12 -<br />

Wichita CCOP - 12 - - 9 8 - 7 - 13 6 -<br />

Yale University - - - - - - - - - - 2 -<br />

ACOSOG - - - - - - - - - - 8 -<br />

CALGB - - - - - - - - - - 81 -<br />

CTSU-NOS - - - - - - - - - - 3 -<br />

ECOG - - - - - - - - - - 94 -<br />

NCCTG - - - - - - - - - - 91 -<br />

NSABP - - - - - - - - - - 11 -<br />

RTOG - - - - - - - - - - 9 -<br />

Total 13 34 12 237 84 89 47 85 61 192 815 39<br />

S0635<br />

S0636<br />

S0709<br />

S0720<br />

S0722<br />

S0802<br />

S0819<br />

S0905<br />

Note: Some studies may not be listed because they were either closed prior to July 1, 2011 or because<br />

they are currently active but have not had any accrual through September 6, <strong>2012</strong>.<br />

SWOG • Leading Cancer Research. Together.


86 <strong>Fall</strong> <strong>2012</strong><br />

LYMPHOMA COMMITTEE<br />

Committee Leadership<br />

Chair:<br />

Vice-Chair:<br />

Executive Officer:<br />

Statisticians:<br />

Scientific Leadership<br />

Translational Medicine:<br />

Radiation Oncology:<br />

Pathology<br />

Early Therapeutics:<br />

Designates<br />

Clinical Research Associates:<br />

Cancer Control:<br />

Data Coordinators:<br />

Nurse:<br />

Patient Advocate:<br />

Pharmaceutical Science:<br />

Protocol Coordinator:<br />

Time/Location<br />

Saturday, October 20, <strong>2012</strong><br />

Room: Regency C<br />

11:30 a.m. – 3:30 p.m.<br />

■■<br />

■■<br />

■■<br />

■■<br />

Richard I. Fisher, M.D.<br />

Thomas P. Miller, M.D.<br />

Harry P. Erba, M.D., Ph.D.<br />

Michael LeBlanc, Ph.D.<br />

Hongli Li, M.S.<br />

Richard E. Davis, M.D.<br />

Louis S. Constine, M.D.<br />

Lisa M. Rimsza, M.D.<br />

Daruka Mahadevan, M.D., Ph.D.<br />

Ellen Chase, B.S.<br />

Erin M. Cebula, M.P.H.<br />

John W. Hayslip, M.D.<br />

Jeri Jardine<br />

Iris Syquia<br />

Nancy H. Sprouse, R.N.<br />

Hildy Dillon, M.P.H.<br />

Lara M. Au, Pharm.D.<br />

Megan Hardin<br />

Agenda<br />

Hodgkin Lymphoma<br />

S0816, “A Phase II Trial of Response-Adapted Therapy of Stage<br />

III-IV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging.”<br />

Drs. Press, Friedberg, Brown, Rimsza and Cook. Activated:<br />

7/1/09.<br />

CTSU/CALGB 50604, “Phase II Trial of Response-Adapted<br />

Chemotherapy Based on Positron Emission Tomography for<br />

Non-Bulky Stage I and II Hodgkin Lymphoma.” Dr. Shustov.<br />

Activated: 8/1/10.<br />

E2410, “A Phase II Trial of Response-Adapted Therapy Based<br />

on Positron Emission Tomography (PET) for Bulky Stage I and<br />

II Classical Hodgkin Lymphoma (HL)”. Dr. Shustov. Activated:<br />

4/2/12.<br />

Non-Hodgkin Lymphoma<br />

S0806, “A Phase I/II Trial of Vorinostat (SAHA) (NSC-701852)<br />

in Combination with Rituximab-CHOP in Patients with Newly<br />

SWOG • Leading Cancer Research. Together.<br />

■■<br />

■■<br />

■■<br />

Diagnosed Advanced Stage Diffuse Large B-Cell Lymphoma<br />

(DLBCL).” Drs. Persky, Miller and Rimsza. Activated: 11/15/10.<br />

S1001, “A Phase II Trial of PET-Directed Therapy for Limited<br />

Stage Diffuse Large B-Cell Lymphoma (DLBCL).” Drs. Persky,<br />

Miller, Constine, Rimsza, and Fitzgerald. Activated: 7/18/11.<br />

S1106, “ A Randomized Phase II Trial of R-HCVAD-MTX/<br />

ARA-C Induction Followed by Consolidation With an Autologous<br />

Stem Cell Transplant vs. R-Bendamustine Induction Followed<br />

by Consolidation With an Autologous Stem Cell Transplant<br />

for Previously Untreated Patients


LYMPHOMA COMMITTEE<br />

SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 87<br />

■■<br />

■■<br />

■■<br />

■■<br />

Translational Medicine Studies<br />

S8809/S9800/S9911, “Association of Fcg receptor genotypes<br />

with response and clinical benefit with addition of rituximab to<br />

CHOP chemotherapy in patients with follicular lymphoma (FL)<br />

and diffuse large B cell lymphoma (DLBCL).” Drs. Persky and<br />

Rimsza.<br />

S8516/S8736/S9125/S9240/S9349/S9704/S0014,<br />

“Pharmacogenomics of Oxidative Stress-Related Genes in<br />

Lymphoma.“ Drs. Briehl, Rimsza and Ambrosone.<br />

S8947/S9800/S9911/S0016, “Vitamin D Insufficiency and<br />

Follicular Lymphoma Prognosis.” Drs. Kelly and Friedberg.<br />

S9704/S0014/S0313A, “Determining the Cell of Origin and<br />

Prognostic Gene Signatures in SWOG Trials of Diffuse Large<br />

B-Cell Lymphoma.” Drs. Persky and Rimsza.<br />

Other Business<br />

Translational Medicine Subcommittee Report (Dr. Davis)<br />

Publications<br />

The publications listed below are those that have been received in<br />

published, submitted or accepted form by the <strong>Group</strong> Chair’s Office<br />

since the Spring <strong>2012</strong> meeting agenda booklet publication list.<br />

Published/Accepted Manuscripts<br />

■■<br />

S0016 A phase III randomized intergroup trial of CHOP chemotherapy<br />

plus rituximab compared to CHOP chemotherapy plus<br />

131iodine-tositumomab for previously untreated follicular nonhodgkins<br />

lymphoma (SWOG S0016). OW Press, JM Unger, L<br />

Rimsza, JW Friedberg, M LeBlanc, M Czuczman, M Kaminski, R<br />

Braziel, C Spier, AK Gopal, DG Maloney, B Cheson, S Dakhil, TP<br />

Miller, RI Fisher. Journal of Clinical Oncology, accepted 8/20/12.<br />

■■<br />

■■<br />

S0350 Phase II trial of cisplatin plus etoposide plus gemcitabine<br />

plus solumedrol (PEGS) in peripheral T-cell non-Hodgkins<br />

lymphoma (SWOG S0350). D Mahadevan, J Unger, C Spier, D<br />

Persky, F Young, M LeBlanc, RI Fisher, TP Miller. Cancer <strong>2012</strong><br />

Jul 25 [Epub ahead of print]. http://www.ncbi.nlm.nih.gov/<br />

pubmed/22833464<br />

S0515 A phase II trial of R-CHOP plus bevacizumab for patients<br />

with newly diagnosed diffuse large b-cell non-hodgkin lymphoma:<br />

SWOG 0515. A Stopeck, JM Unger, LM Rimsza, M LeBlanc,<br />

B Farnsworth, M Iannone, MJ Glenn, RI Fisher, TP Miller.<br />

Blood 120(6):1210-1217, <strong>2012</strong>. http://www.ncbi.nlm.nih.gov/<br />

pubmed/22734071<br />

■■<br />

E2946 A randomized phase III trial of ABVD vs. Stanford V<br />

+/- radiation therapy in locally extensive and advanced stage<br />

hodgkins lymphoma: an intergroup study coordinated by the<br />

Eastern Cooperative Oncology <strong>Group</strong> (E2496). L Gordon, F<br />

Hong, RI Fisher, NL Bartlett, JM Connors, R Gascoyne, H<br />

Wagner, P Stiff, B Cheson, M Gospodarowicz, R Advani, B Kahl,<br />

J Friedberg, K Blum, T Habermann, J Tuscano, RT Hoppe, SJ<br />

Horning. Journal of Clinical Oncology, accepted 8/27/12.<br />

Submitted Manuscripts<br />

■■<br />

S0213 A phase II multicenter trial of HyperCVAD MTX/Ara-C<br />

and rituximab in patients < 70 years of age with previously<br />

untreated mantle cell lymphoma: SWOG 0213. SH Bernstein,<br />

EM Epner, JM Unger, M LeBlanc, E Cebula, WR Burack, LM<br />

Rimsza, TP Miller, RI Fisher. Annals of Oncology, submitted<br />

9/12.<br />

■■<br />

■■<br />

■■<br />

■■<br />

BMT/CTN 0401 Phase III randomized study of rituximab/<br />

carmustine, etoposide, cytarabine, melphalan (BEAM) compared<br />

with 131-iodine tositumomab/BEAM with autologous stem<br />

cell transplantation for relapsed diffuse large b-cell lymphoma<br />

(DLBCL): results from the Blood and Marrow Transplant Clinical<br />

Trials Network (BMT CTN) 0401 trial. J Vose, S Carter, LJ<br />

Burns, E Ayala, O Press, C Moskowitz, E Stadtmauer, S Mineshi,<br />

R Ambinder, T Fenske, M Horowitz, RI Fisher, M Tomblyn.<br />

Journal of Clinical Oncology, submitted 9/4/12.<br />

E2496 Gene expression and overall survival in advanced stage<br />

classic hodgkin lymphoma. DW Scott, FC Chan, F Hong, S Rogic,<br />

K Tan, B Meissner, S Ben-Neriah, M Boyle, R Kridel, A Telenius,<br />

B Woolcock, P Farinha, RI Fisher, L Rimsza, NL Bartlett, L<br />

Shepherd, RH Advani, JM Connors, BS Kahl, LI Gordon, SJ<br />

Horning, C Steidl, RD Gascoyne. Journal of Clinical Oncology,<br />

resubmitted with revisions 8/13/12.<br />

E2496 Plasma Epstein-Barr viral DNA as a marker of tumor<br />

response in Hodgkin lymphoma. JA Kanakry, H Li, LL Gellert,<br />

MV Lemas, W Hsieh, F Hong, KL Tan, R Gascoyne, LI Gordon,<br />

RI Fisher, NL Bartlett, P Stiff, B Cheson, R Advani, L Rimsza, B<br />

Hahl, SJ Horning. Blood, submitted 8/31/12.<br />

E2496 Efficacy and tolerability of ABVD and Stanford V in<br />

elderly hodgkin lymphoma from US intergroup trial E2496. AM<br />

Evens, F Hong, L Gordon, RI Fisher, P Stiff, T Miller, N Bartlett,<br />

J Connors, R Gascoyne, H Wagner, M Gospodarowicz, B Cheson,<br />

R Advani, R Hoppe, B Kahl, S Horning. Blood, under review<br />

8/24/12.<br />

SWOG • Leading Cancer Research. Together.


88 <strong>Fall</strong> <strong>2012</strong><br />

Lymphoma Committee<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

C50303<br />

C50604<br />

CTN0701<br />

Arizona, U of - 1 - 7 8 6 4 1 - 3<br />

Arkansas, U of - 1 - 1 - 1 3 - - -<br />

BC Cancer Agency - - - 1 - - - - - -<br />

Boston MC MBCCOP - - - - - - 1 - - -<br />

Boston Univ Med Ctr - - - - - - 2 - - -<br />

Brooke Army Med Ctr 2 2 - - - - - - - -<br />

Central IL CCOP 3 1 - 3 8 - 7 - - -<br />

City of Hope Med Ctr - 5 - - - 4 4 - - -<br />

Cleveland Clinic OH 1 3 - - - - 3 - - -<br />

Colorado, U of - - - - - - 1 - - -<br />

Columbia River CCOP - - - - - - 2 - - -<br />

Columbia University - - - - - - 4 - - -<br />

Columbus CCOP - - - - 3 - - - - -<br />

Davis, U of CA 4 1 2 2 - - 5 - - -<br />

Dayton CCOP - - - - 5 2 1 - 1 -<br />

Grand Rapids CCOP - - - - 4 - 1 - - -<br />

H Lee Moffitt CC - - 1 - - - - - - -<br />

Harrington CC 4 - - - - - - - - -<br />

Hawaii MBCCOP, U of - - - - - - 6 - - -<br />

Henry Ford Hosp - - - - - - 2 - - -<br />

KaiserPermanenteNCAL - - - 1 - - 3 - - -<br />

Kansas City CCOP - - - - - 3 - - - -<br />

Kansas, U of 5 - - - 2 - 3 - - -<br />

Kentucky, U of - 1 - 2 - - 3 - 1 -<br />

LSU-New Orleans CCOP - 2 - - - - 1 - - -<br />

LSU-Shreveport CCOP - - - 2 - - 2 - - 1<br />

Loyola University 1 - - 2 6 3 3 - - 1<br />

MD Anderson - - - - - - 16 - - -<br />

MUSC, Hollings CC 2 - - - - - 3 - - -<br />

Michigan CRC CCOP - - - 1 - - 5 - - -<br />

Michigan, U of - - - - - - 12 - - -<br />

Mississippi, Univ of 2 - - - - - - - - -<br />

Montana CCOP - - - - 3 - 1 - - -<br />

New Mexico MBCCOP 1 - - - - - 1 - - -<br />

Oregon Hlth Sci Univ - 1 - - - - - - - 1<br />

Providence Hosp 2 - - - - - - - - -<br />

S0350<br />

S0801<br />

S0806<br />

S0816<br />

S1001<br />

S1106<br />

S1108<br />

SWOG • Leading Cancer Research. Together.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 89<br />

Lymphoma Committee<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

C50303<br />

C50604<br />

CTN0701<br />

Puget Sound 7 1 - 2 19 1 13 - - -<br />

Rochester, Univ of 4 6 - 9 11 11 17 8 6 4<br />

San Antonio, U of TX 5 - - - - - - - - 1<br />

So Calif, U of 1 - - - - 2 - - - -<br />

Southeast CCC CCOP - - - - 2 1 2 - - -<br />

St Louis CCOP - - - - 2 - - - - -<br />

St Louis University 2 1 - - - - - - 1 -<br />

Tennessee, U of - - - - 1 - - - - -<br />

Upstate Carolina - 1 - 1 1 - 3 - - -<br />

Utah, U of - - - - 6 - 2 - - -<br />

Wayne State Univ - - - - - - 3 - - -<br />

Wichita CCOP 1 2 - - 6 3 4 1 1 -<br />

Yale University - - - - - - 1 - - -<br />

AMC - - - - - - 3 - - -<br />

CALGB - - - - - - 86 1 7 14<br />

ECOG - - - - - - 81 - 3 -<br />

NCCTG - - - - - - 15 - - -<br />

NSABP - - - - - - 3 - - -<br />

Total 47 29 3 34 87 37 332 11 20 25<br />

S0350<br />

S0801<br />

S0806<br />

S0816<br />

S1001<br />

S1106<br />

S1108<br />

Note: Some studies may not be listed because they were either closed prior to July 1, 2011 or because they are currently active but have not had any accrual through September 6, <strong>2012</strong>.<br />

SWOG • Leading Cancer Research. Together.


90 <strong>Fall</strong> <strong>2012</strong><br />

MELANOMA COMMITTEE<br />

Committee Leadership<br />

Chair:<br />

Vice-Chair:<br />

Executive Officer:<br />

Statisticians:<br />

Scientific Leadership<br />

Translational Medicine:<br />

Radiation Oncology:<br />

Surgery:<br />

Medical Oncology:<br />

Pathology:<br />

Non-Melanoma Skin Cancer:<br />

Early Therapeutics:<br />

Designates<br />

Clinical Research Associates:<br />

Cancer Control Liaison:<br />

Data Coordinator:<br />

Nurse:<br />

Patient Advocate:<br />

Pharmaceutical Science:<br />

Protocol Coordinator:<br />

Friday, October 19, <strong>2012</strong><br />

Room: Crystal A Ballroom<br />

7:30 a.m. – 9:30 a.m.<br />

Time/Location<br />

Agenda<br />

Antoni Ribas, M.D., Ph.D.<br />

William E. Carson III, M.D.<br />

Bruce G. Redman, D.O.<br />

Megan Othus, Ph.D.<br />

James Moon, M.S.<br />

Kim A. Margolin, M.D.<br />

Evan J. Wuthrick, M.D.<br />

Robert H.I. Andtbacka, M.D.<br />

Lawrence E. Flaherty, M.D.<br />

Jane L. Messina, M.D.<br />

Sancy A. Leachman, M.D., Ph.D.<br />

TBD<br />

Sandy Allten, R.N., O.C.N.<br />

TBD<br />

Jennie Barrett<br />

Karen L. Mack, R.N.P.<br />

Ann M. Lau Clarke, R.N., M.S.N.<br />

Valerie Guild<br />

Jorge G. Avila, Pharm.D.<br />

Lara M. Au, Pharm.D.<br />

TBD<br />

Presentation<br />

How young adult research can be embedded into studies being developed<br />

in the SWOG Melanoma Committee (20 minutes)<br />

Leonard Sender, M.D., UCI<br />

Discussion on the imaging initiative (10 minutes)<br />

Kenneth F. Grossmann M.D., Ph.D. University of Utah.<br />

Update on Newly Proposed Studies (5-10 minutes each)<br />

■ ■ “Randomized Phase II Trial of Standard HD-IFN or HD-IFN for<br />

One Month Followed by Pegylated-Interferon.” Dr. Carson.<br />

■ ■<br />

■■<br />

■ ■<br />

“Ipilimumab in Patients With Acral and Mucosal Melanoma.” Dr.<br />

Lao.<br />

ECOG 1612, “A Randomized Phase III Trial of Vemurafenib<br />

vs Ipilimumab in Patients with Advanced BRAFV600 Mutant<br />

Melanoma.” Dr. Chmielowski.<br />

“A Randomized Phase II study of the Combination of Carboplatin<br />

and Paclitaxel with or without Vemurafenib in patients with<br />

Metastatic Melanoma Harboring a V600 BRAF Mutation whose<br />

Tumors Have Progressed on a Prior BRAF Inhibitor.” Dr. Kim.<br />

Active Studies (5-10 Minutes each)<br />

■■<br />

CTSU/E2607, “A Phase II Trial of Dasatinib in KIT-Positive<br />

Patients with Unresectable Locally Advanced or Stage IV<br />

Mucosal, Acral and Vulvovaginal Melanomas.” Dr. Margolin.<br />

Activated: 12/1/11.<br />

■■<br />

CTSU/E1609, “A Phase III Randomized Study of Adjuvant<br />

Ipilimumab Anti-CTLA4 Therapy Versus High-Dose Interferon<br />

Alpha-2b for Resected High-Risk Melanoma.” Dr. Flaherty.<br />

Activated: 7/15/11.<br />

Closed Studies (5-10 minutes each)<br />

■■<br />

S0933, “Phase II Study of RO4929097 (NSC-749225) in<br />

Advanced Melanoma.” Drs. Margolin and Gajewski. Activated:<br />

10/28/10; Closed: 11/15/11.<br />

■■<br />

S0826, “A Phase II Trial of SCH 727965 (NSC 747135) in<br />

Patients with Stage IV Melanoma.” Drs. Lao and Fruehauf.<br />

Activated: 7/1/09; Closed: 2/9/10.<br />

Proposed Studies<br />

■■<br />

S1303, “Phase II trial of Trametinib in NRAS mutant melanoma.”<br />

Dr. Daud.<br />

■■<br />

■■<br />

S1223, “An Open-Label, Single-Arm Phase II Study of TH-302<br />

in Combination with Paclitaxel in Patients with Advanced<br />

Melanoma.” Dr. Cranmer.<br />

S1221, “Safety and efficacy of a AKT inhibitor in combination<br />

with dabrafenib in patients with acquired resistance to BRAF<br />

inhibitor-based therapy mediated by non-MAPK reactivation<br />

mechanisms.” Drs. Ribas and Lo.<br />

■■<br />

EORTC 18081: “Adjuvant Pegylated-Interferon in Stage IIb.” Dr.<br />

Sondak.<br />

■■<br />

S1208, “Prospective Validation of Karyometric Analysis of<br />

Cutaneous Squamous Cell Carcinoma.” Drs. Krouse and Glazer.<br />

SWOG • Leading Cancer Research. Together.


Publications<br />

The publications listed below are those that have been received in<br />

published, submitted or accepted form by the <strong>Group</strong> Chair’s Office<br />

since the Spring <strong>2012</strong> meeting agenda booklet publication list.<br />

Published/Accepted Manuscripts<br />

No publication information for this cycle.<br />

Submitted Manuscripts<br />

■■<br />

S0512 Phase II trial of sorafenib in combination with carboplatin<br />

and paclitaxel in patients with carboplatin and paclitaxel in<br />

patients with metastatic uveal melanoma: SWOG S0512. S<br />

Bhatia, J Moon, K Margolin, J Weber, C Lao, M Othus, A<br />

Aparicio, A Ribas, V Sondak. PLoS ONE, undergoing revisions in<br />

response to reviewers’ comments 8/17/12.<br />

MELANOMA COMMITTEE<br />

SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 91<br />

SWOG • Leading Cancer Research. Together.


92 <strong>Fall</strong> <strong>2012</strong><br />

Melanoma Committee<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

E1609<br />

E1697<br />

E2607<br />

S0826<br />

Arizona, U of 5 10 - - 1<br />

Arkansas, U of 17 10 - 2 -<br />

Atlanta Reg CCOP - 12 - - -<br />

Bay Area CCOP - - - 1 -<br />

Baylor Univ Med Ctr 8 - - - -<br />

Beaumont CCOP - 3 - - 1<br />

Boston MC MBCCOP - - - 1 -<br />

Cincinnati MC, U of 2 4 - - -<br />

City of Hope Med Ctr - 2 - - -<br />

Cleveland Clinic OH 1 3 - - -<br />

Colorado, U of 12 2 - 3 -<br />

Columbia River CCOP - 14 - 4 -<br />

Columbia University 1 - - - 1<br />

Columbus CCOP - - - - 3<br />

Davis, U of CA 6 16 - - -<br />

Dayton CCOP 1 9 - 4 1<br />

Grand Rapids CCOP 3 - - 6 1<br />

Greenville CCOP 1 - - - -<br />

Gulf Coast MBCCOP - - - - 1<br />

H Lee Moffitt CC 15 2 - - -<br />

Harrington CC - 2 - - -<br />

Hawaii MBCCOP, U of - - 1 - -<br />

Irvine, U of CA 1 - - 1 -<br />

KaiserPermanenteNCAL 2 10 - - -<br />

Kansas City CCOP - - - 2 1<br />

Kansas, U of 2 2 - 1 1<br />

LSU-New Orleans CCOP - - - 2 -<br />

LSU-Shreveport - 1 - - -<br />

LSU-Shreveport CCOP - - - - 1<br />

Lahey Clinic Med Ctr 4 - - - -<br />

Loyola University 1 1 - 3 2<br />

MD Anderson - 1 - - -<br />

Michigan CRC CCOP - - - 2 -<br />

Michigan, U of 2 1 - 11 6<br />

Mississippi, Univ of 1 - - - -<br />

Montana CCOP 1 - - - 2<br />

Nevada Cancer Inst - - - 2 -<br />

Northwest CCOP 1 - - - -<br />

Ohio State Univ 1 - - - -<br />

Oregon Hlth Sci Univ 5 1 - 1 -<br />

S0933<br />

SWOG • Leading Cancer Research. Together.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 93<br />

Melanoma Committee<br />

Cumulative Accrual by Institution and Study<br />

For the Period Ending September 6, <strong>2012</strong><br />

E1609<br />

E1697<br />

E2607<br />

S0826<br />

Ozarks Reg CCOP 3 2 - - -<br />

Puget Sound 6 5 - 1 3<br />

Rochester, Univ of 1 2 - 2 1<br />

San Antonio, U of TX 6 6 - 2 2<br />

Southeast CCC CCOP 3 7 - 4 2<br />

Southern Nevada CCOP - - - - 1<br />

St Louis CCOP 1 - - 3 2<br />

Tennessee, U of - - - 2 -<br />

Univ of Chicago MC - - - - 1<br />

Upstate Carolina - - - - 1<br />

Utah, U of 6 8 - 4 -<br />

Wayne State Univ 2 8 - 8 -<br />

Wichita CCOP - - - - 1<br />

Total 121 144 1 72 36<br />

S0933<br />

Note: Some studies may not be listed because they were either closed prior to July 1, 2011 or because they are currently<br />

active but have not had any accrual through September 6, <strong>2012</strong>.<br />

SWOG • Leading Cancer Research. Together.


94 <strong>Fall</strong> <strong>2012</strong><br />

Future <strong>Group</strong> <strong>Meeting</strong> Dates<br />

Mark Your Calendar!<br />

— May 1-4 —<br />

San Francisco, CA<br />

2013<br />

— October 9-12 —<br />

Chicago, IL<br />

— April 30-May 3 —<br />

San Francisco, CA<br />

2014<br />

— Oct 29-Nov 1 —<br />

Chicago, IL<br />

Check the SWOG website (swog.org) for updates!<br />

SWOG • Leading Cancer Research. Together.


SWOG <strong>Group</strong> <strong>Meeting</strong> Agenda 95<br />

Do you have a few minutes between<br />

meetings Stop by the SWOG registration<br />

desk in the East Tower Concourse to check<br />

your e-mail and/or print your boarding pass!<br />

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<strong>Fall</strong> <strong>2012</strong> <strong>Group</strong> <strong>Meeting</strong> Commercial Supporters*<br />

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