NCT00392899

Tegafur-Uracil or Observation in Treating Patients With Stage II Colorectal Cancer That Has Been Completely Removed By Surgery

Randomized Phase III Trial of Adjuvant Chemotherapy With UFT vs. Observation in Curatively Resected Stage II Colon Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,025 (actual)
• Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	UFT adjuvant chemotherapy	UFT is given at a dose of 500-600 mg/day as tegafur in 2 divided doses after meals for 5 days, followed by a 2-day rest. This one-week cycle is repeated for one year.

Timeline

• Start date: 2006-10-01
• Primary completion: 2015-10-01
• Completion: 2016-09-01
• First posted: 2006-10-26
• Last updated: 2016-09-28

Locations

272 sites across 1 country: Japan