Real-World Effectiveness of Bevacizumab Based on AURELIA in Platinum-resistant Recurrent Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
This study will evaluate the efficacy and safety profile, response rate, progression free survival, overall survival of bevacizumab (Avastin) added to chemotherapy in patients with epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma with disease progression within 6 months of platinum treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients who have histologically or cytologically confirmed recurrent epithelial ovarian cancer, fallopian tube cancer, or peritoneal cancer.
- •Patients who have platinum-resistant disease (defined as having relapsed within 6 months of her last platinum-containing regimen)
- •Patients who have underwent chemotherapy of either weekly paclitaxel + bevacizumab, topotecan + bevacizumab, pegylated liposomal doxorubicin + bevacizumab in 2nd line or 3rd line chemotherapy.
排除标准
- •Patients with previous treatment with bevacizumab.
- •Patients who received bevacizumab combination therapy in 4th line or more chemotherapy.
研究组 & 干预措施
Pegylated liposomal doxorubicin + bevacizumab
干预措施: Bevacizumab (Drug)
Topotecan + bevacizumab
干预措施: Bevacizumab (Drug)
Pegylated liposomal doxorubicin + bevacizumab
干预措施: Pegylated liposomal doxorubicin (Drug)
Weekly paclitaxel + bevacizumab
干预措施: Weekly paclitaxel (Drug)
Weekly paclitaxel + bevacizumab
干预措施: Bevacizumab (Drug)
Topotecan + bevacizumab
干预措施: Topotecan (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: 36 months
PFS was defined as the time from the date of randomization to the first documented disease progression or death, whichever occurred first. Progression was based on tumor assessment made by the investigators according to the RECIST criteria
Incidence of Treatment-Emergent Adverse Events
时间窗: 36 months
Safety and tolerability will be assessed in deaths, laboratory data, and vital signs. Number of participants with treatment-related adverse events as assessed by CTCAE version 4.0.
次要结局
- overall survival (OS)(36 months)
- Response rate(36 months)