An Open Label Study of the Effect of Adjuvant Treatment With Capecitabine in Combination With Oxaliplatin on Disease-Free Survival in Patients With Stage III Colon Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 主要终点
- Disease-Free Survival (Time to Event)
研究概览
简要总结
This observational study evaluates the efficacy and safety of capecitabine in combination with oxaliplatin in the adjuvant setting in participants with Stage III colon cancer. Data were collected from each participant for up to 36 months or until disease recurrence.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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, >/= 18 years of age
- •Treatment in line with the currently approved indication in the Summary of Product Characteristics
排除标准
- •Contraindications according to the current Summary of Product Characteristics
研究组 & 干预措施
Capecitabine + Oxaliplatin
Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.
干预措施: Capecitabine (Drug)
Capecitabine + Oxaliplatin
Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.
干预措施: Oxaliplatin (Biological)
结局指标
主要结局
Disease-Free Survival (Time to Event)
时间窗: Up to 3 years
Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of colon cancer, or death due to any cause).
次要结局
- Safety: Percentage of Participants With Adverse Events(Up to 3 years)