Chemosensitivity Test to Evaluate the Effect of Adjuvant Cancer Chemotherapy (S-1) After Gastric Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 36
- 主要终点
- Overall survival rate
研究概览
简要总结
To evaluate the usefulness of chemosensitivity test in evaluating the appropriate adjuvant cancer chemotherapy after gastric surgery
详细描述
Patients: clinical Stage III gastric cancer patients. Informed consent will be obtained before surgery. Eligible patients: surgical Stage II, IIIA and IIIB gastric cancer patients. Chemosensitivity test: The surgical specimen will be sent Mitsubishi BCL, Co. Ltd. to be tested by CD-DST chemosensitivity test and RT-PCR for thymidylate synthetase and dihydropyrimidine dehydrogenase mRNA. The test results will be blinded for the doctors on duty.
Treatment: All the patients will be treated with S-1 at a dose of 80 mg/m2 b.i.d. for 4 weeks followed by 2 weeks rest. The treatment will be continued until the recurrence or 1 year after operation.
Primary endpoint: 3-years disease-free survival rate Secondary endpoint: 3-years overall survival rate and side effect (CTCAE v3.0) Evaluation of chemosensitivity test: The cutoff condition will be determined based on the accumulated data of CD-DST and mRNAs.
Hypothesis
The responder detected by CD-DST and/or TS, DPD mRNA will have a favorable survival outcome comparing with resistant cases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •histologically proven gastric cancer
- •PS (ECOG) 0 or 2
- •D2 dissection, curability B or more
- •surgical Stage IIIA and IIIB
- •negative peritoneal cytology
- •no previous radiotherapy, chemotherapy and hormone therapy
- •possible peroral intake at 6 POW
- •no severe surgical complication
- •normal bone marrow, liver and renal function
- •complete chemosensitivity test
- •written informed consent
排除标准
- •multiple cancer
- •contraindication for S-1
- •history of drug allergy (grade 3)
- •severe complication
- •watery diarrhea
- •scirrhous gastric cancer
- •the other patients who was judged as inadequate for trial by doctor on duty
研究组 & 干预措施
1
干预措施: S-1 (Drug)
结局指标
主要结局
Overall survival rate
时间窗: at three years
次要结局
- Side effect(During administration of drug)