Adult men and women over the age of 18 with resected (surgically removed), stage III, colorectal cancer for research study.
A Phase III Trial Of 6 Versus 12 Treatments Of Adjuvant Folfox Plus Celecoxib Or Placebo For Patients With Resected Stage III Colon Cancer
Weiss Geoffrey, R
UVa Health System, Cancer Center, Division of Hematology/Oncology seeks adult men and women over the age of 18 with resected (surgically removed), stage III, colorectal cancer for research study. The purpose of the study is to compare the effects of having 6 versus 12 cycles of a chemotherapy treatment called FOLFOX in combination with either an experimental medicine called celecoxib or a placebo (a harmless substance that looks like the experimental medicine). Twelve (12) cycles of FOLFOX is a standard treatment used to prevent colon cancer from coming back, but the addition of celecoxib to FOLFOX chemotherapy is experimental. Also, having 6 cycles of FOLFOX, with either placebo or celecoxib, is experimental. The study involves screening visit(s) to determine eligibility, blood draws, imaging scans, 6 or 12 treatment cycles with FOLFOX, oral medicine placebo or celecoxib during FOLFOX and after FOLFOX for a total of 3 years, and follow-up visits every 6 months. Each participant will have 7 – 13 study visits for eligibility and FOLFOX treatment, followed by visits every 3 months for 3 years while taking placebo or celecoxib only. After treatment, follow-up visits will occur every 6 months. Eligibility and treatment visits will take 8 hours of time. Follow-up visits for placebo/celecoxib alone or for post-treatment visits will take 4 hours. ? Celecoxib or placebo will be provided free of charge. ? Participant and/or their insurance company will be billed for the cost of FOLFOX and its administration. Participant and/or insurance company will pay for all tests and procedures. ? No compensation is provided for this study. Contact Information: For more information please contact: • Erin Yarde, BA, MS • 434-243-8588 / firstname.lastname@example.org • IRB-HSR # 15651 Principal Investigator: Hanna Sanoff, MD