Randomized Phase III Trial of Adjuvant Chemotherapy With UFT vs. Observation in Curatively Resected Stage II Colon Cancer
- Compare the efficacy of adjuvant tegafur-uracil vs observation only in patients with
curatively resected stage II colorectal cancer.
- Compare relapse-free and overall survival of patients treated with these regimens.
- Compare the occurrence of adverse events in patients treated with these regimens.
OUTLINE: This is a randomized, controlled study. Patients are randomized to 1 of 2 treatment
- Arm I: Patients undergo observation.
- Arm II: Patients receive oral tegafur-uracil on days 1-5. Treatment repeats every 7
days for 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Kenichi Sugihara, MD, PhD
Tokyo Medical and Dental University
United States: Federal Government