A Randomized, Multicentral, Controlled, Phase III Study to Compare Adjuvant Chemotherapy With S-1 Plus Oxaliplatin to S-1 Alone After Curative Distal Gastrectomy in Locally Advanced Gastric Cancer
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 29
- 试验地点
- 15
- 主要终点
- disease-free survival
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of S-1 plus Oxaliplatin versus S-1 only as adjuvant chemotherapy after curative distal gastrectomy in patients with locally advanced gastric cancer.
详细描述
The study is a multi-central, controlled, randomized Phase III trial. The protocol has been approved by the Ethics Committee of Beijing Cancer Hospital. The primary endpoint is the 3-year progression-free survival (PFS) rate. The secondary endpoints are the overall survival (OS) and safety.
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 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •sign written informed consent form
- •age ≥ 18 years, ≤69 years
- •ECOG status: 0~2
- •pathologically confirmed gastric cancer at stage II or IIIA (AJCC 7th version)
- •negative peritoneal cytology
- •underwent curative distal gastrectomy with D2 lymph node dissection
- •no prior antitumor treatment is allowed, including chemotherapy, radiotherapy, immune therapy or target therapy
- •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
- •be enrolled in other clinical trials
- •underwent prior antitumor treatment
- •allergic reaction to S-1 or oxaliplatin
- •abnormal GI tract function
- •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
研究组 & 干预措施
A: postoperative Oxaliplatin plus S-1
Patients in arm A will receive standard distal gastrectomy with D2 lymphadenectomy first, and 8 cycles of adjuvant Oxaliplatin plus S-1 (SOX) later.
Oxaliplatin: 130mg/m2, iv drip for 2h, d1, q3W S-1: 40~60mg bid, po, d1~14, q3W (6 months)
干预措施: Oxaliplatin plus S-1 (Drug)
B: postoperative S-1 only
Patients in arm B will receive standard distal gastrectomy with D2 lymphadenectomy first, and 16 cycles of adjuvant S-1 later.
S-1: 40~60mg bid, po, d1~14, q3W (12 months)
干预措施: S-1 only (Drug)
结局指标
主要结局
disease-free survival
时间窗: 5 years
次要结局
- overall survival(up to 5 years)
- Incidence of Treatment-Emergent Adverse Events [Safety](1 year)