A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-CC)
Phase 3
Completed
- Conditions
- Colorectal Cancer
- Interventions
- Procedure: Surgery alone
- Registration Number
- NCT00152230
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
This is a controlled study designed to compare relapse-free survival and overall survival in patients receiving UFT with those in patients receiving surgery alone. Patients will be randomly assigned to surgery alone or surgery followed by UFT within 6 weeks after curative resection. To assess treatment efficacy, data on recurrence and survival will be collected for 5 years after enrollment of the last patient. To evaluate safety, data on adverse events will be collected for 12 months after the start of treatment.Evaluations will be separately done for colon cancer and rectal cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 900
Inclusion Criteria
- Age 20 to 75
- Performance status 0 , 1, or 2 (ECOG)
- Hematopoietic WBC ≥ 4,000/mm^3 Platelet ≥ 100,000/mm^3
- Hepatic AST and ALT ≤ 2 times upper limit of normal(ULN) Total bilirubin ≤ 1.2mg/dL
- Renal BUN ≤ 25mg/dL Creatinine ≤ 1.5mg/dL
Exclusion Criteria
- Prior anticancer treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 UFT (uracil, tegafur) UFT (uracil, tegafur) 2 Surgery alone Surgery alone
- Primary Outcome Measures
Name Time Method Relapse-free survival and overall survival every course for first three courses, then every other course
- Secondary Outcome Measures
Name Time Method Adverse events any time
Trial Locations
- Locations (1)
National Cancer Center Hospital East
🇯🇵6-5-1, Kashiwanoha, Kashiwa, Chiba, Japan