Colorectal Cancer Clinical Trial
Official title:
Randomized Phase III Trial of Adjuvant Chemotherapy With UFT vs. Observation in Curatively Resected Stage II Colon Cancer
RATIONALE: Drugs used in chemotherapy, such as tegafur-uracil, work in different ways to
stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving chemotherapy after surgery may kill any tumor cells that remain after
surgery. Sometimes, after surgery, the tumor may not need more treatment until it
progresses. In this case, observation may be sufficient. It is not yet known whether
chemotherapy is more effective than observation in treating colorectal cancer.
PURPOSE: This randomized phase III trial is studying tegafur and uracil to see how well they
work compared to observation in treating patients with stage II colorectal cancer that has
been completely removed by surgery.
OBJECTIVES:
Primary
- Compare the efficacy of adjuvant tegafur-uracil vs observation only in patients with
curatively resected stage II colorectal cancer.
Secondary
- 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
arms.
- 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, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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