Phase III, Randomized, Double Blind, Placebo Controlled Study of Rofecoxib in Colorectal Cancer Patients Following Adjuvant Chemotherapy
- Compare the overall survival of patients with previously resected stage II or III
colorectal cancer treated with rofecoxib vs placebo administered for at least 2 years
vs 5 years.
- Compare the relapse-free survival of patients treated with these regimens.
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients
are stratified according to participating center, site of disease (colon vs rectum), disease
stage (II vs III), age, adjuvant chemotherapy (yes vs no), and type of chemotherapy regimen
(1 vs 2 vs 3 vs 4 vs 5). Within 3 months of surgical resection alone or completion of
adjuvant radiotherapy and/or chemotherapy after surgical resection, patients are randomized
to one of four treatment arms.
- Arm I: Patients receive oral rofecoxib once daily for 2 years.
- Arm II: Patients receive oral rofecoxib once daily for 5 years.
- Arm III: Patients receive oral placebo once daily for 2 years.
- Arm IV: Patients receive oral placebo once daily for 5 years. Treatment continues in
all arms in the absence of disease recurrence or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 7,000 patients (1,750 per treatment arm) will be accrued for
this study within 5 years.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
David J. Kerr, MD, FRCP, DSc
Oxford University Hospitals NHS Trust
United States: Federal Government