A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-GC)
Phase 3
Completed
- Conditions
- Gastric Cancer
- Interventions
- Procedure: Surgery alone
- Registration Number
- NCT00152243
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
This is a controlled study designed to evaluate the efficacy of UFT on survival compared with surgery alone. Patients will be randomly assigned to receive either surgery alone or surgery followed by UFT within 6 weeks after curative resection. To assess treatment response, 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 16 months after the start of treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
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 ≤ 1.5 times ULN
- Renal BUN ≤1.5 times ULN Creatinine ≤ 1.5 times ULN
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 Overall survival and relapse-free 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)
Cancer Institute Hospital, Japanese Foundation for Cancer Research
🇯🇵3-10-6, Ariake, Koto-ku, Tokyo, Japan