Adjuvant Chemotherapy Trial of TS-1 for Gastric Cancer (ACTS-GC)
Phase 3
Completed
- Conditions
- Gastric Cancer
- Interventions
- Drug: TS-1 (S-1)Procedure: Surgery
- Registration Number
- NCT00152217
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
This controlled study is designed to evaluate the efficacy of TS-1 on survival compared with surgery alone. Patients will be randomly assigned to receive either surgery alone or surgery followed by treatment with TS-1 within 45 days after curative resection (curability A or B). To assess the efficacy, data on recurrence and survival will be collected from the time of enrollment until 5 years after surgery. To evaluate safety, data on adverse events will be collected from the time of enrollment until 1 year after surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria
- Age 20 to 80
- Hematopoietic WBC ≥ 4,000/mm^3 Platelet ≥ 100,000/mm^3
- Hepatic AST and ALT ≤ 2.5 times upper limit of normal(ULN) Total bilirubin ≤ 1.5 mg/dL
- Renal Creatinine ≤ULN
Exclusion Criteria
- Prior anticancer treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 TS-1 (S-1) TS-1 (S-1) 2 Surgery Surgery alone
- Primary Outcome Measures
Name Time Method Overall survival every course for first three courses, then every other course
- Secondary Outcome Measures
Name Time Method Relapse-free survival, adverse events any time
Trial Locations
- Locations (1)
National Cancer Center Hospital
🇯🇵5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
National Cancer Center Hospital🇯🇵5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan