An Open-label, Multicenter, Randomized, 3 Arm Study of S-1 Compared With S-1/CDDP, or S-1/CDDP Compared With 5-FU/CDDP in Patients With Advanced Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
This is an open-label, multicenter, three arm, parallel, randomized, Phase 3 study evaluating the efficacy and safety of S-1 alone compared with S-1 plus CDDP, and S-1 plus CDDP compared with 5-FU plus CDDP in patients with advanced gastric cancer previously untreated with chemotherapy for advanced disease. Patients will be randomly assigned (1:1:1) to S-1 (Arm A), S-1/CDDP (Arm B) or 5-FU/CDDP (Arm C). Patients will be stratified to achieve balanced distribution of patients to each arm according to following stratifications, performance status (0, 1, or 2), the number of metastatic sites (1 vs >1), prior gastrectomy, and center.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-prior chemotherapy treated advanced gastric adenocarcinoma
- •Age 18 and over
- •Performance status 0, 1, or 2 (ECOG)
- •Life expectancy 3 months
- •Hematopoietic WBC lower limit of normal-12,000/mm^3 Absolute granulocyte count ≥ 2,000/mm^3 Platelet count ≥ 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 ≥ 60 mL/min
排除标准
- •Interstitial pneumonia, pulmonary fibrosis
- •Myocardial infarction within the last 6 months, severe/unstable angina, congestive heart failure
- •Intestinal paralysis, intestinal obstruction, uncontrollable diabetes
研究组 & 干预措施
1
S-1
干预措施: S-1 (Drug)
2
S-1 plus CDDP
干预措施: S-1 plus CDDP (Drug)
3
5-FU plus CDDP
干预措施: 5-FU plus CDDP (Drug)
结局指标
主要结局
Response rate
时间窗: every course for first three courses, then every other course
次要结局
- Safety profile, time to treatment failure(any time)