Celecoxib Polyp Prevention Trial in Participants With Resected Stage I Colon Cancer
- Compare celecoxib vs placebo, in terms of decreasing the incidence of adenomatous
polyps of the colon and rectum, in patients with resected stage I adenocarcinoma of the
- Compare disease-free survival of patients treated with these regimens.
- Compare the effect of these regimens on self-reported symptoms and health-related
quality of life of these patients.
- Compare the quality of life of patients treated with these regimens.
- Compare the benefits of celecoxib in patients with primary tumors or polyps that
express cyclo-oxygenase-2 (COX-2) with those that do not express COX-2.
- Compare the expression of signaling targets such as serine/threonine AKT, extracellular
signal-regulated kinase 2 (ERK2), and endoplasmic reticulum Ca+2- ATPases in the index
tumor and polyps.
- Determine the toxicity and safety of celecoxib in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to gender, tumor stage (T1 vs T2), age (≤ 49 vs 50 to 59 vs ≥ 60
years), and current aspirin use (yes vs no). Patients are randomized to 1 of 2 treatment
- Arm I: Patients receive oral celecoxib twice daily for 3 years.
- Arm II: Patients receive oral placebo twice daily for 3 years. In both arms, treatment
continues in the absence of unacceptable toxicity or the diagnosis of invasive colon
cancer, carcinoma in situ of the colon or rectum, or a non-colon primary cancer.
Quality of life is assessed at baseline and then at 6, 12, 24, 36, and 42 months.
Patients are followed at 6 months and at 2 years.
PROJECTED ACCRUAL: A total of 1,200 patients (600 per treatment arm) will be accrued for
this study within 2.5 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
To determine whether celecoxib 400 mg bid for 3 years will decrease the incidence of adenomatous polyps of the colon and rectum in participants with Stage I adenocarcinoma of the colon.
Norman Wolmark, MD
NSABP Foundation, Inc.
United States: Federal Government
|Allegheny General Hospital||Pittsburgh, Pennsylvania 15212-4772|