An Open-Label Randomized International Multi-Center Phase III Study of Capecitabine (Xeloda) in Combination With Cisplatin Versus FU/Cisplatin in Patients With Advanced and/or Metastatic Gastric Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 316
- 主要终点
- Time to disease progression
研究概览
简要总结
This study will evaluate the efficacy and safety of oral capecitabine (Xeloda) versus 5-fluorouracil (5-FU), in combination with intravenous (IV) cisplatin, in participants with advanced and/or metastatic gastric cancer. The anticipated time on study treatment is at least 6 weeks and continued up to disease progression, and the target sample size is 300 individuals.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 to 75 years of age
- •Advanced and/or metastatic gastric cancer with at least 1 measurable lesion
排除标准
- •Uncontrolled infection
- •Evidence of central nervous system (CNS) metastases
- •History of other malignancy within the last 5 years, except cured basal cell cancer of the skin or cured in-situ cancer of the uterine cervix
- •Radiation therapy or major surgery within 4 weeks of study drug
- •Previous chemotherapy
研究组 & 干预措施
5-Fluorouracil + Cisplatin
Participants will receive 5-FU in combination with cisplatin upto disease progression.
干预措施: 5-Fluorouracil (Drug)
5-Fluorouracil + Cisplatin
Participants will receive 5-FU in combination with cisplatin upto disease progression.
干预措施: Cisplatin (Drug)
Capecitabine + Cisplatin
Participants will receive capecitabine in combination with cisplatin upto disease progression.
干预措施: Capecitabine (Drug)
Capecitabine + Cisplatin
Participants will receive capecitabine in combination with cisplatin upto disease progression.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Time to disease progression
时间窗: Up to approximately 7.3 years
次要结局
- Objective tumor response rate(Up to approximately 7.3 years)
- Time to response(Up to approximately 7.3 years)
- Duration of response(Up to approximately 7.3 years)
- Incidence of adverse events(Up to approximately 7.3 years)
- Overall survival(Up to approximately 7.3 years)