An Open Label Study to Evaluate the Safety of Xeloda as Adjuvant Monotherapy in Patients Who Have Undergone Surgery for Colon Cancer, Dukes Stage C.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 228
- 主要终点
- Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE
研究概览
简要总结
This single arm study will evaluate the safety profile of Xeloda as monotherapy for adjuvant treatment of colon cancer. All patients will receive Xeloda 1250mg/m2 p.o. twice daily as intermittent treatment (3 week cycles consisting of 2 weeks of treatment followed by 1 week without treatment). 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
- Non Randomized
- 干预模型
- Single Group
- 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 patients, >=18 years of age;
- •colon cancer (Dukes stage C);
- •surgery, with no evidence of remaining tumor;
- •ECOG performance status of <=1.
排除标准
- •previous therapy for currently treated colon cancer;
- •any evidence of metastatic disease;
- •history of other malignancy within last 5 years;
- •clinically significant cardiac disease.
研究组 & 干预措施
1
干预措施: capecitabine [Xeloda] (Drug)
结局指标
主要结局
Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE
时间窗: Up to 25 weeks (from Baseline to the end of safety follow-up)
The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately. The percentage of participants with an AE, serious AE, or AE resulting in death was calculated as \[number of participants with event divided by number analyzed\] multiplied by 100.
次要结局
- Percentage of Participants With Early Withdrawal or Discontinuation Due to an AE(Up to 25 weeks (from Baseline to the end of safety follow-up))