NCT02151370已完成不适用
Ascites Control Treating Ovarian Cancer With Bevacizumab: "ACT-OB"
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
- The proportion of patients who require paracenthesis during treatment with Avastin
研究概览
简要总结
This observational study will collect data about safety in female patients with advanced ovarian epithelial cancer with measurable residual disease after surger y. The treating physician has decided to treat the patients with Avastin (bevaci zumab) in combination with chemotherapy followed by Avastin monotherapy accordin g to the local label. Data will be collected for 72 weeks.
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
- •Female patients over 18 years of age
- •Histologically confirmed Advanced Epithelial Ovarian Cancer
- •Confirmed ascites prior to surgery
- •Residual disease after surgery
- •Patients are chemotherapy naïve or have received only one prior line of treatment for their disease
- •International Federation of Gynecology and Obstetrics (FIGO) stage IIIb or IV disease
- •Eastern Cooperative Oncology Group (ECOG) performance status <=2
- •Patients must meet treatment eligibility requirements according to treating physician and Summary of Product Characteristics (SmPC) criteria for Avastin plus chemotherapy.
排除标准
- •Pregnancy or lactation
- •Low grade tumors, since this does not necessarily requires systemic treatment. Complete surgical resection
- •Uncontrollable hypertension
- •Unexplained bleeding
- •Known hypersensitivity to any components of bevacizumab
- •All contraindications specified in the respective Summary of Product Characteristics (SmPC) and/or local labelling of Avastin and the corresponding chemotherapy must be adhered to by the physician.
结局指标
主要结局
The proportion of patients who require paracenthesis during treatment with Avastin
时间窗: 72 weeks
The amount of ascitic fluid extracted during treatment with Avastin
时间窗: 72 weeks
次要结局
- Safety: Incidence of adverse events(72 weeks)
- To evaluate Eastern Cooperative Oncology Group (ECOG) performance status before and after start of therapy(72 weeks)
- To determine regional epidemiologic data for the studied population(72 weeks)
研究者
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