An Open Label Study of the Effect of First Line Treatment With Bevacizumab in Combination With Capecitabine and Oxaliplatin on Progression-free Survival in Patients With Metastatic Cancer of the Colon and Rectum
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 主要终点
- Progression-free Survival
研究概览
简要总结
This prospective observational study will evaluate the efficacy and safety of bevacizumab in combination with capecitabine and oxaliplatin as first-line treatment in participants with colorectal cancer. Data will be collected from each participant until disease progression occurs (for up to 30 months).
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 patients, >/= 18 years of age
- •Metastatic colorectal cancer
- •Treatment in accordance with current Summary of Product Characteristics and local guidelines
排除标准
- •Contraindications according to current Summary of Product Characteristics and local guidelines
研究组 & 干预措施
Bevacizumab
Participants will receive bevacizumab in combination with capecitabine and oxaliplatin.
干预措施: Bevacizumab (Biological)
Bevacizumab
Participants will receive bevacizumab in combination with capecitabine and oxaliplatin.
干预措施: Capecitabine (Biological)
Bevacizumab
Participants will receive bevacizumab in combination with capecitabine and oxaliplatin.
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Progression-free Survival
时间窗: From randomization to progression or death during the study (up to approximately 30 months)
Progression-free survival was defined as the interval between the day of first treatment and the first documentation of disease progression or death and was assessed by the investigators according to modified Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was defined as an increase in sum of lesions size by more than 20% or new lesions.
次要结局
- Response Rate (Tumor Assessments According to RECIST)(Up to approximately 30 months)
- Percentage of Participants With Adverse Events(Up to approximately 30 months)