NCT01697488已完成不适用
Non-interventional Surveillance Study (NIS) on First-line (FL) Bevacizumab (Avastin) in Combination With Carboplatin/Paclitaxel in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,090
- 试验地点
- 1
- 主要终点
- Efficacy: Progression-free survival
研究概览
简要总结
This observational study will evaluate the safety, efficacy, quality of life and predictive/selection factors for Avastin (bevacizumab) in combination with carboplatin/paclitaxel in first line in patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer in clinical practice. Data of eligible patients will be collected during up to 15 months of treatment and 12 months of follow-up. A second recruitment phase has been opened to focus on patients >/= 70 years.
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
- •Study phase 1: Patients aged >/= 18 years
- •Study phase 2: Patients aged >/= 70 years
- •Newly diagnosed advanced epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer with indication for a first-line carboplatin/paclitaxel chemotherapy in combination with Avastin
排除标准
- •Contraindications to Avastin according to Summary of Product Characteristics
结局指标
主要结局
Efficacy: Progression-free survival
时间窗: up to approximately 27 months
Safety: Incidence of adverse events
时间窗: approximately 5 years
次要结局
- Quality of life: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30/QLQ-OV28 questionnaires(up to approximately 27 months)
- Selection criteria for first-line treatment with Avastin and carboplatin/paclitaxel: clinical/demographic patient characteristics(approximately 5 years)
- Treatment duration(approximately 5 years)
- Treatment discontinuations/modifications(approximately 5 years)
研究者
研究点 (1)
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