Compare S-1 Plus Oxaliplatin to S-1 as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer (CAPITAL)
A Prospective,Multicentral,Open-label,Randomized,Controlled,Phase III Clinical Trial to Compare S-1 Plus Oxaliplatin to S-1 as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer
Background: It is shown that TS-1 as adjuvant chemotherapy after D2 resection in patients with gastric cancer can improve DFS and OS in one Japanese Trial. And TS-1 has become one of the standard therapies to these patients. But it is still unknown whether it would improve more to OS and DFS than single TS-1 after combined with oxaliplatin . This trial is designed to investigate the efficacy and safety of TS-1 plus oxaliplatin versus TS-1 single as adjuvant chemotherapy after D2 resection in patients with gastric cancer.
Patients and methods: In this study , patients with histologically confirmed gastric cancer who received D2 resection and staged II or III, aged from 18 to 70 years and with Eastern Cooperative Oncology Group performance status ≤2 and adequate organ function, are randomized 1:1 to oxaliplatin 100mg/m2 on day 1 and TS-1 40~60mg twice everyday for 14 days in a 21-days cycle for total 6 cycles followed by TS-1 single with the same dose and frequency to the end of the 1st year postoperatively(SOX) , or TS-1 single 40~60mg twice everyday for 14 days in a 21-days cycle to the end of the 1st year postoperatively (TS-1). The primary end point is overall survival (OS), and secondary end point is disease free survival(DFS) and safety. Final study analysis will be conducted in the end of the 5th year after the last patient's enrollment.
研究概览
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
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Guangdong
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Chaozhou、Guangdong、中国
- the central hospital of Chaozhou
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Foshan、Guangdong、中国
- The 1st People's Hospital of Foshan
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Guangzhou、Guangdong、中国
- Cancer center of Sun Yat-sen University
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Guangzhou、Guangdong、中国
- cancer center of Guangzhou medical college
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Guangzhou、Guangdong、中国
- Guangdong Traditional Medical Hospital
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Guangzhou、Guangdong、中国
- the 1st affliated hospital of Guangdong pharmacuetic college
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Guangzhou、Guangdong、中国
- the 1St Affliated Hospital of Guangzhou Medical College
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Guangzhou、Guangdong、中国
- the 6th affliated hospital of Sun-yat-sen University
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Shantou、Guangdong、中国
- the 1st hospital of Shantou University
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Shantou、Guangdong、中国
- the cental hospital of Shantou
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Shaoguan、Guangdong、中国
- YUE-BEI people's hospital
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Shenzhen、Guangdong、中国
- The 2nd People's Hospital of Shenzhen
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Zhuhai、Guangdong、中国
- the 5th hospital of Sun-yat-sen University
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- informed consensus of patients
- be able to receive oral administration
- from 18 to 70 years old
- be proven to be primary adenocarcinoma of gastric cancer and staged II or III by pathological evidences
- without other chemotherapy and/or radiation against to the disease
- normal function of other organs including heart,liver ,kidney and so on
- Eastern Cooperative Oncology Group performance status:0~2
Exclusion Criteria:
- history of other malignancy
- allergic reaction to S-1 or oxaliplatin
- be enrolling in other clinical trials
- abnormal GI tract function
- dysfunction of other organs
- female in pregnancy or lactation,or refuse to receive Contraception measures during chemotherapy
- other situation to be judged not adaptive to the study by investigators
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：S-1 plus Oxaliplatin
6 courses chemotherapy with S-1 plus oxaliplatin followed by 10 courses S-1 single after d D2 resection
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6 courses chemotherapy with S-1 plus oxaliplatin followed by 10 courses S-1 single after d D2 resection
其他名称：
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有源比较器：S-1 single
S-1 40~60mg twice daily for 14 days in 3 weeks for totally 16 courses after D2 resection
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16 courses S-1 single after d D2 resection
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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总生存期
大体时间：5年
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5年
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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无病生存
大体时间：3年
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3年
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出现不良事件的参与者人数
大体时间：5年
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5年
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合作者和调查者
调查人员
- 学习椅：Zhiwei Zhou, PHD、SunYat-sen University
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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