A Phase III Study Comparing Adjuvant Chemotherapy Consisting of Capecitabine/Oxaliplatin Versus Surgery Alone in Patients With Stage II (T1N2, T2N1, T3N0), IIIa (T2N2, T3N1, T4N0) and IIIb (T3N2) Gastric Adenocarcinoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,035
- 主要终点
- Disease-free survival rate
研究概览
简要总结
This study will compare capecitabine/oxaliplatin as adjuvant chemotherapy versus observation alone in chemotherapy-naive participants who have undergone potentially curative resection for gastric cancer. Participants will be randomized to either the chemotherapy arm or the observation arm. Capecitabine will be administered orally, 1000 milligrams per meter-squared (mg/m^2) twice daily (BID) on Days 1 to 15 of a 3-week cycle, for 8 cycles, and oxaliplatin will be administered as an intravenous (IV) infusion, 130 mg/m^2 every 3 weeks for 8 cycles. The anticipated time on study treatment in 6 months and the target sample size is 1024 individuals.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants greater than or equal to (>=) 18 years of age
- •Gastric adenocarcinoma, Stage II, IIIa or IIIb
- •Potentially curative resection of tumor within 6 weeks prior to randomization
- •Previously untreated with chemotherapy or radiotherapy
排除标准
- •Serious concomitant medical illnesses that would limit life expectancy to less than (<) 5 years
- •Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study
- •Any evidence of metastatic disease (including presence of tumor cells in the ascites)
研究组 & 干预措施
Capecitabine + Oxaliplatin
Patients will receive oral capecitabine (1000 mg/m^2 BID on Days 1 to 15 ) plus IV oxaliplatin (130 mg/m^2 on Day 1) during each 3-week cycle for up to 8 cycles (6 months).
干预措施: Capecitabine (Drug)
Capecitabine + Oxaliplatin
Patients will receive oral capecitabine (1000 mg/m^2 BID on Days 1 to 15 ) plus IV oxaliplatin (130 mg/m^2 on Day 1) during each 3-week cycle for up to 8 cycles (6 months).
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Disease-free survival rate
时间窗: 3 years
次要结局
- Overall survival(5 years)
- Incidence of adverse events(5 years)