NCT00152217已完成3 期
Adjuvant Chemotherapy Trial of TS-1 for Gastric Cancer (ACTS-GC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Prior anticancer treatment
研究组 & 干预措施
1
Experimental
TS-1 (S-1)
干预措施: TS-1 (S-1) (Drug)
2
Other
Surgery alone
干预措施: Surgery (Procedure)
结局指标
主要结局
Overall survival
时间窗: every course for first three courses, then every other course
次要结局
- Relapse-free survival, adverse events(any time)
研究者
研究点 (1)
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