Multicenter, Double-Blind, Placebo-Controlled Randomized Phase III Study of Adjuvant Therapy With Celecoxib in Combination With Chemotherapy in Patients With Curatively Resected Stage III Colon Cancer
- Compare disease-free survival of patients with curatively resected stage III
adenocarcinoma of the colon treated with adjuvant fluorouracil and leucovorin calcium
with or without celecoxib.
- Compare the overall survival, the occurrence of new primary colon cancer, and the
development of new polyps in patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to ≥ 4 tumor-positive lymph nodes (yes vs no), form of adjuvant
chemotherapy (infusional vs bolus), low-dose aspirin for cardiovascular prophylaxis (yes vs
no), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive fluorouracil and leucovorin calcium IV for up to 6 courses in
the absence of disease recurrence or unacceptable toxicity. Patients also receive oral
celecoxib twice daily.
- Arm II: Patients receive oral placebo twice daily and fluorouracil and leucovorin
calcium as in arm I.
In both arms, treatment with celecoxib or placebo continues for 3 years in the absence of
disease recurrence or unacceptable toxicity.
Patients are followed annually for 2 years.
PROJECTED ACCRUAL: A total of 1,450 patients (725 per treatment arm) will be accrued for
this study within 2 years.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Disease-free survival as measured by Logrank every 3 months in year 1, every 6 months in years 2-3, and annually thereafter
Cornelis J.H. van de Velde, MD, PhD, FRCS, FRCPS
Leiden University Medical Center
United States: Federal Government