NCT03071848已完成不适用
Retrospective Multicenter Observational Study to Evaluate Safety and Effectiveness of Bevacizumab (Avastin®) in Combination With Paclitaxel and Cisplatin/Carboplatin or Toptecan in Patients With Advanced Cervical Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 12
- 主要终点
- Percentage of Participants With Gastrointestinal (GI) and Genitourinary (GU) Fistulas and GI Perforations
研究概览
简要总结
This study will evaluate the safety of bevacizumab (Avastin®) combined with standard chemotherapy in participant with advanced cervical cancer, with special focus on the incidence of gastrointestinal (GI) and genitourinary (GU) fistulas and GI perforations in the common practice setting.
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
- •Age 18 or older
- •Diagnosis of primary stage IVB, recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy
- •Retrospective clinical decision made to initiate therapy with bevacizumab (Avastin®) combined with standard chemotherapy (cisplatin or carboplatin or topotecan and paclitaxel) between 01 January 2015 and 01 January 2016
- •All participants must have received at least one dose of bevacizumab combined with standard chemotherapy between 01 January 2015 and 01 January 2016 AND have at least 12 months of documented follow up, from treatment start, unless died or lost to follow up within the minimum study entry follow up period
- •Availability of documentation of for advanced cervical cancer (including prior treatment as applicable) and follow up in the participant's medical records
排除标准
- •Participation during the study period in an interventional clinical trial or any other interventional study that may impact advanced cervical cancer outcome
- •Participants who have received prior therapy with any anti-VEGF drug, including bevacizumab
结局指标
主要结局
Percentage of Participants With Gastrointestinal (GI) and Genitourinary (GU) Fistulas and GI Perforations
时间窗: Up to 12 months
Participants with GI and GU fistulas and GI perforation events will be reported according to Common Terminology Criteria for Adverse Events (CTCAE V4.0).
次要结局
- Percentage of Participants With Selected Adverse Events of Special Interest (AESIs)(Up to 12 months)
- Percentage of Participants who Received Radiotherapy Prior to GI and GU Fistulas and GI Perforation Events(Up to 12 months)
- Percentage of Participants who Received Internal, External and Other Radiotherapy(Up to 12 months)
- Number of Doses of Prior Radiotherapy(Up to 12 months)
- Overall Response Rate (ORR)(Up to 12 months)
- Progression Free Survival (PFS)(Up to 12 months)
- Overall Survival (OS)(Up to 12 months)
研究者
研究点 (12)
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