A Randomized Phase III Trial of Postoperative Chemotherapy or Chemo-radiotherapy for Locally Advanced Gastric Cancer After D2 Resection
试验速览
- 阶段
- 3 期
- 入组人数
- 408
- 试验地点
- 1
- 主要终点
- DFS
研究概览
简要总结
The purpose of this study is to explore the efficacy of adjuvant radiotherapy for D2 resected gastric cancer
详细描述
The radiotherapy dose of 45Gy in 25 fractions as adjuvant treatment after D2 surgery for gastric cancer
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
- •Aged 18-75；
- •Had histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction；
- •Subjects has to voluntarily join the study and sign the Informed Consent Form for the study;
- •D2 and R0 resection;
- •Locally advanced (UICC stage, T4, N2, N3) gastric cancer after surgery;
- •More than 15 lymph nodes;
- •Adequate organ function as defined below: Hematologic ANC ≥ 2*109/L, Platelets ≥ 100*109/L, AST and ALT ≤ 2.5×ULN, TBIL ≤ 1.5×ULN.
排除标准
- •Previous radiotherapy or chemotherapy；
- •Inadequate organ function;
- •Pregnant or lactating women or women of childbearing potential.
研究组 & 干预措施
Chemotherapy
Adjuvant chemotherapy group receive 8 cycles of XELOX (Oxaliplatin 130mg/m2, ivdrip, D1,capecitabine 1000mg po, Bid, D1-14, Q21D)
干预措施: Chemotherapy (Drug)
Chemo-radiotherapy
Adjuvant chemo-radiotherapy group receive 6 cycles of XELOX (Oxaliplatin 130mg/m2, ivdrip, D1, capecitabine 1000mg po, Bid, D1-14, Q21D) and concurrent chemo-radiotherapy (capecitabine 825mg po, Bid, d1-5, QW)
干预措施: Concurrent chemo-radiotherapy (Radiation)
结局指标
主要结局
DFS
时间窗: 36 months
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
次要结局
- OS(36 months)
研究者
Xianglin Yuan
Professor, Head of the cancer center
Huazhong University of Science and Technology