BELOVA: A Non-Interventional Study to Collect Data on the Safety and Efficacy of Frontline Bevacizumab Treatment in Ovarian Cancer Patients 70 Years and Older
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 26
- 主要终点
- Percentage of Participants with Adverse Events
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy in the frontline treatment of ovarian cancer in participants 70 years of age and older in routine clinical practice in Belgium. Bevacizumab will be used in combination with carboplatin/paclitaxel followed by bevacizumab as maintenance in accordance with the Summary of Product Characteristics (SmPC).
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
- 70 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 70 years and older
- •No treatment with any other investigational agent within 28 days or 2 half-lives (whichever is longer) prior to enrollment
排除标准
- •Contraindications, warnings, and precautions for bevacizumab
研究组 & 干预措施
Elderly Participants with Ovarian Cancer
Elderly participants aged 70 years and older administered frontline treatment for International Federation for Gynecology and Obstetrics (FIGO) stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer with bevacizumab in combination with chemotherapy according to standard of care.
干预措施: Bevacizumab (Drug)
Elderly Participants with Ovarian Cancer
Elderly participants aged 70 years and older administered frontline treatment for International Federation for Gynecology and Obstetrics (FIGO) stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer with bevacizumab in combination with chemotherapy according to standard of care.
干预措施: Carboplatin (Drug)
Elderly Participants with Ovarian Cancer
Elderly participants aged 70 years and older administered frontline treatment for International Federation for Gynecology and Obstetrics (FIGO) stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer with bevacizumab in combination with chemotherapy according to standard of care.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Percentage of Participants with Adverse Events
时间窗: Per routine clinical practice during bevacizumab treatment (up to 15 months)
Time to First Incidence of Adverse Events of Special Interest
时间窗: Per routine clinical practice during bevacizumab treatment (up to 15 months)
次要结局
- Dosage of Bevacizumab in Milligrams per Kilogram (mg/kg)(Every 3 weeks according to SmPC for up to 15 months)
- Percentage of Participants with Complete or Partial Response According to RECIST(Per routine clinical practice during bevacizumab treatment (up to 15 months) and at 6 and 12 months after end of bevacizumab (approximately 27 months overall))
- Overall Survival(Per routine clinical practice during bevacizumab treatment (up to 15 months) and at 6 and 12 months after end of bevacizumab (approximately 27 months overall))
- Comprehensive Geriatric Assessment Subscale Scores(Baseline, end of chemotherapy (up to 18 weeks), and after 10 and 15 months of bevacizumab treatment or at disease progression (up to 15 months overall))
- Percentage of Participants by Chemotherapy Used in Combination with Bevacizumab(Every 3 weeks per routine clinical practice for up to 18 weeks)
- Total Number of Bevacizumab Doses(Every 3 weeks according to SmPC for up to 15 months)
- Progression-Free Survival According to Response Evaluation Criteria in Solid Tumors (RECIST)(Per routine clinical practice during bevacizumab treatment (up to 15 months) and at 6 and 12 months after end of bevacizumab (approximately 27 months overall))