Randomized Phase II Study of S-1 (SOX) or Capecitabine (XELOX) in Combination With Oxaliplatin in Patients With Recurrent or Metastatic Gastric Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, S-1, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving oxaliplatin together with S-1 is more effective than giving oxaliplatin together with capecitabine.
PURPOSE: This randomized phase II trial is studying how well giving oxaliplatin together with S-1 works compared to oxaliplatin given together with capecitabine in treating patients with recurrent, metastatic, or unresectable gastric cancer.
详细描述
OBJECTIVES:
Primary
- To evaluate the time to progression in patients with recurrent or metastatic gastric cancer treated with oxaliplatin in combination with S-1 vs capecitabine.
Secondary
- To assess progression-free survival, overall response, disease-control rate, time-to-treatment failure, response duration, time to response, overall survival, safety, quality of life, pharmacogenetics, and psychologic distress/coping strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive oral S-1 twice daily on days 1-14 and oxaliplatin IV over 2 hours on day 1.
干预措施: oxaliplatin (Drug)
Arm I
Patients receive oral S-1 twice daily on days 1-14 and oxaliplatin IV over 2 hours on day 1.
干预措施: tegafur-gimeracil-oteracil potassium (Drug)
Arm II
Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin as in arm I.
干预措施: capecitabine (Drug)
Arm II
Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin as in arm I.
干预措施: oxaliplatin (Drug)
结局指标
主要结局
Progression-free survival
次要结局
- Time to progression