NCT01863693已完成不适用
AN OBSERVATIONAL STUDY OF AVASTIN® (BEVACIZUMAB) AS FIRST LINE THERAPY IN PATIENTS WITH ADVANCED OVARIAN CANCER
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 30
- 主要终点
- Safety: Incidence of adverse events
研究概览
简要总结
This multicenter, prospective, observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in combination with chemotherapy as first-line treatment in patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer in routine clinical practice. Eligible patients will be followed for approximately 15 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult patients, >/= 18 years of age
- •Advanced (FIGO stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube or primary peritoneal cancer not previously treated with chemotherapy
- •Initiating Avastin in combination with chemotherapy
排除标准
- •Contraindications, warnings and precautions for use as specified in the Avastin Summary of Product Characteristics
结局指标
主要结局
Safety: Incidence of adverse events
时间窗: approximately 6 years
Progression-free survival, defined as time from first administration of first-line therapy to documented disease progression
时间窗: approximately 6 years
次要结局
- Objective response rate, defined as percentage of patients with complete or partial response according to local assessments(approximately 6 years)
- Quality of life: EQ-5D/EORTC questionnaires(approximately 6 years)
- Composition of first-line chemotherapy regimens: drugs/dosage/duration(approximately 6 years)
- Overall survival, defined as time from first administration of first-line therapy to documented death(approximately 6 years)
- Dosage/schedule/duration of Avastin therapy(approximately 6 years)
研究者
研究点 (30)
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