An Open-Label Randomized Phase III Study Comparing Xeloda (Capecitabine) With IV Bolus 5-Fluorouracil in Combination With Low-Dose Leucovorin as Adjuvant Chemotherapy in Patients Who Underwent Surgery for Dukes C Colon Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,987
- 主要终点
- Disease-free Survival
研究概览
简要总结
This 2 arm study will compare the safety and efficacy of oral Xeloda, or 5-fluorouracil in combination with leucovorin, in patients who have undergone surgery for colon cancer. Patients will be randomized to receive either Xeloda 1250mg/m2 po bid on days 1-14 every 21 days, or leucovorin 20mg/m2 iv + 5-fluorouracil 425mg/m2 iv daily from day 1 to day 5 every 28 days. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
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
- •adult patients 18-75 years of age;
- •histologically confirmed colon cancer with potentially curative resection of the tumor within 8 weeks before study initiation.
排除标准
- •previous chemotherapy
研究组 & 干预措施
Capecitabine
Participants received capecitabine 1250 milligram per square meter (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
干预措施: Capecitabine [Xeloda] (Drug)
5-Fluorouracil + Leucovorin
Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
干预措施: 5-Fluorouracil (Drug)
5-Fluorouracil + Leucovorin
Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
干预措施: Leucovorin (Drug)
结局指标
主要结局
Disease-free Survival
时间窗: Approximately 3 years
Participants with disease-free survival were reported. Disease-free survival was assessed as the number of days between randomization and the first time at which relapse, a new occurrence of colon cancer, or death was recorded, or the last time at which a participant was known to be disease free (censoring time).
次要结局
- Relapse-Free Survival(Approximately 3 years)
- Overall Survival(Approximately 3 years)
- Mean Change From Baseline in Global Health Status at Week 25(Baseline (Days -7 to 1) and at Week 25)
- Number of Participants With Abnormalities for Blood Chemistry and Hematological Parameters(Up to Week 25)
- Number of Participants With Any Adverse Events and Serious Adverse Events(Up to Week 29)