Copy of 2003 Group Newsletter 12 15 - SWOG

Page 4
Cancer Control Research Committee Report
Against the backdrop of Kansas City, already famous for
mouth-watering barbecue and spicy jazz, the Cancer Control
Research Committee held a full day of activities during the fall Group
meeting of the Southwest Oncology Group.
Molecular Epidemiology Committee
First on the day’s agenda was the Molecular Epidemiology
Committee meeting, led by Dr. Regina M. Santella, who summarized
the previous day’s meeting of the entire team of key PCPT P01
investigators. The primary purpose of this meeting was to discuss
the NCI Draft Review Report of the peer review conducted Sept. 7-
9, which included the latest major development of the study. The
next step in the P01 review process is further evaluation by other NCI
review committees in the coming months.
Other items discussed at the Molecular Epidemiology
Committee meeting included:
• Pharmacogenetic/molecular epidemiologic studies,
including the R01-funded studies “Pharmacogenetics: Breast Cancer
Treatment and Prognosis” (SWOG-8897), “Lung Cancer in
Women,” and an ancillary case-control study within the Selenium
and Vitamin E Cancer Prevention Trial (SELECT).
• Research blood specimens of SELECT and PCPT.
• The recently reviewed resubmission of the NCI Program
Project (P01) application, “Biology of the Prostate Cancer Prevention
Trial” which involves several key members of the subcommittee.
Chemoprevention Subcommittee
During the three-hour session led by Dr. Gary E. Goodman,
the subcommittee held major discussions regarding two proposed
new cancer chemoprevention studies that are coming closer to
activation:
• S0300, “Chemoprevention of Breast Cancer with the
Cyclooxygenase-2 Inhibitor Celecoxib: Phase II Trial”
• S0212, “Phase IIb Placebo-Controlled Trial of Oral
Celecoxib for High-Grade Squamous Intraepithelial Lesions of the
Cervix.”
Several other proposals were discussed, including Calcium,
Aspirin and Selenium [CASE] for Preventing Colorectal Cancer and
Polyp Recurrence; Tamoxifen versus Letrozole for Breast Cancer
Prevention; and a study with Selenium in Patients with Barrett’s
Esophagus.
The subcommittee also discussed updates of open studies
including S9917, “L-Selenium-based Chemoprevention of Prostate
Cancer among Men with High-Grade Prostatic Intaepithelial
Neoplasia,” which has an accrual of 317 randomized men, as well as
ongoing matters for the closed SELECT study (S0000).
CCRC Open Meeting
CCRC Chair Dr. Scott M. Lippman convened the threehour
CCRC Open Meeting which featured the keynote address by
Behavioral and Health Outcomes (BAHO) Subcommittee Chair Dr.
Carolyn G. Gotay. Dr. Gotay’s presentation, “Behavioral
Interventions for Preventing Cancer: State of the Science and
Implications for Southwest Oncology Group Research,” discussed
the role of behavioral factors in cancer etiology, theories of behavior
DECEMBER 2004
THE GROUP NEWSLETTER
change, the relationships between tobacco, diet, and physical
activity and cancer.
Next on the agenda was the Harry E. Hynes CCOP
Symposium, chaired by Dr. J. Philip Kuebler, entitled “Cancer
Control Credits and the Southwest Oncology Group.” Panel members
Dr. Lori Minasian, NCI Research Group Chief; Dr. Gotay, BAHO
Subcommittee Chair; Dr. Goodman, Chemoprevention
Subcommittee Chair; and Dr. James L. Wade III, Central Illinois
CCOP PI; briefly summarized their visions of available, feasible
prevention and control studies for CCOP participation. The following
discussion provided outstanding insights into successfully
conducting CCRC research in the CCOP setting.
BAHO Subcommittee
One of the highlights of the BAHO Subcommittee meeting,
chaired by Dr. Gotay, was the good news that S9908, “A Double-
Blind, Placebo-Controlled Trial to Study the Efficacy and Safety of
Glutamine Supplementation Upon Radiation Therapy-Induced Oral
Mucositis in Head and Neck Cancer Patients,” would be re-activated
after solving the drug reconstitution problems that had caused its
temporary closure. More good news was that the NCI has recently
increased the cancer control credit from 0.5 to 1.0 credit for each
protocol registration.
New on the CTSU menu:
Physician Fact Sheets
Over the next several weeks, the Cancer Trials Support
Unit (CTSU) will be posting Physician Fact Sheets for each of the
treatment protocols on the CTSU menu.
Each fact sheet has a summary of the treatment plan and
study population, as well as the study schema. These are intended
for use by healthcare professionals, not as patient education
materials.
You can find Physician Fact Sheets on the Member Web
site under “Education and Training” (soon to be renamed “Education
and Promotions”). Click on “Protocol-Specific Materials.” You
also can find the fact sheets by searching under “Protocol” and then
selecting “Education and Training documents.”
Informed Consent Form translations
The CTSU has announced that Spanish translations will
be done for consent forms on all protocols on the CTSU menu
except those that are close to accrual or when there is an
expectation of accrual closure.
Consents are translated into French when a CTA is
held by NCIC-CTG or another Cooperative Group with Health
Canada.
How to access translated informed consent forms after
accessing the Member area of the CTSU Web site:
1. Click on “Protocols.”
2. Select a protocol by ID number.
3. Choose “Site Registration Documents.”
4. Translated consent forms are listed by language.