NCT01791140已完成不适用
Program for Assessment of Activity and Safety of 1st-line Bevacizumab (Avastin) Therapy in Elderly Patients With Metastatic Colorectal Cancer (BEVERLY-C Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 主要终点
- Median progression-free survival
研究概览
简要总结
This observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in combination with fluoropyrimidine-based chemotherapy in elderly patients (>/= 65 years of age) with newly diagnosed metastatic colorectal cancer. Patients will be followed until disease progression, death, withdrawal of consent, discontinuation of physician-patient relationship or study closure, whichever comes first.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, >/= 65 years of age
- •Patients with newly diagnosed metastatic colorectal cancer starting first-line treatment with Avastin in combination with fluoropyrimidine-based chemotherapy according to the approved Hungarian Summary of Product Characteristics
- •Patients suitable for Avastin treatment as assessed by the treating physician
排除标准
- •Any contraindications to Avastin treatment according to the Hungarian Summary of Product Characteristics
结局指标
主要结局
Median progression-free survival
时间窗: approximately 3.5 years
次要结局
- Overall response rate (complete response + partial response)(approximately 3.5 years)
- Clinical benefit rate (complete response + partial response + stable disease)(approximately 3.5 years)
- Metastasectomy rate(approximately 3.5 years)
- Mean duration of Avastin treatment(approximately 3.5 years)
- Safety: Incidence of adverse events(approximately 3.5 years)
- Median progression-free survival in subgroup receiving Avastin plus fluorouracil monotherapy(approximately 3.5 years)
- Median progression-free survival according to age group (65-74 years; >/= 75 years)(approximately 3.5 years)
研究者
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