Randomized Phase III Study of TS-1 Alone Versus TS-1 Plus CDDP in Advanced Gastric Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
This study aimed to verify the survival benefit of TS-1 plus CDDP combination chemotherapy compared with the monotherapy by TS-1 alone.
详细描述
This is a randomized, controlled, open-label, parallel, multicenter study. Patients are stratified according to 3 factors ; performance status (ECOG scale: 0, 1, 2), disease stage (unresectable gastric cancer or recurrent gastric cancer (received prior adjuvant chemotherapy or not)) and participating center. Patients are randomized to one of two treatment arms. Arm A: Patients receive oral TS-1 twice daily on days 1-28 followed by 14 days rest. Treatment is repeated every 42 days for up to 4 courses. Arm B: Patients receive CDDP iv on day 8 and oral TS-1 twice daily on days 1-21 followed by 14 days rest. Treatment is repeated every 35 days for up to 5 courses. Patients are followed every 6 months for up to 2 years from the day they participates in this study.
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
- None
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma
- •Unresectable and recurrent gastric cancer
- •Age 20 to 74
- •Performance status 0, 1, or 2 (ECOG)
- •Life expectancy 3 months
- •No prior chemotherapy or radiotherapy for gastric cancer
- •Able to take oral medication
- •Evaluable or not evaluable lesion had already checked more than 28 days before participated in this study
- •Hematopoietic Absolute granulocyte count lower limit of normal-12,000/mm^3 Platelet ≥ 100,000/mm^3 Hemoglobin ≥ 8.0 g/dL
- •Hepatic AST and ALT ≤ 100 U/L ALP ≤ 2 times upper limit of normal (ULN) Bilirubin ≤ 1.5 mg/dL
- •Renal Plasma creatinine ≤ ULN Creatinine clearance ≥ 50 mL/min
排除标准
- •Pregnant or nursing
- •Bleeding from gastrointestinal tract or no diarrhea
- •Hypersensitivity to TS-1 or CDDP
- •Psychiatric disorder that would preclude study compliance or giving informed consent
- •Severe acute or chronic medical or psychiatric condition or laboratory abnormality
- •Serious illness or medical condition
- •Brain metastasis
- •Ascites requiring drainage
研究组 & 干预措施
1
TS-1 and cisplatin
干预措施: TS-1 and cisplatin (Drug)
2
TS-1
干预措施: TS-1 (Drug)
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
- Overall response rate, lesion-directed response rate, time to treatment failure (TTF), hospitalization-free survival period within the periods of TTF, and safety profile(every course for first three courses, then every other course)