Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Cancer Research Campaign Clinical Trials Centre
OBJECTIVES: * 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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
