Multicenter and Retrospective Observational Study to Analyze the Efficacy and Safety of the Combination With Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), According to Data Sheet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 主要终点
- Efficacy progression-free survival (PFS)
研究概览
简要总结
Retrospective Study to Analyze the Efficacy and Safety of Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), According to SmPC.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who have received at least one dose of trabectedin - doxorubicin pegylated for recurrent ovarian cancer according to SMPC, between October 28, 2009 and October 31, 2014 and which have not been included in clinical trials where the IMP was trabectedin.
排除标准
- •Patients with records unavailable (lost, empty or not recoverable).
研究组 & 干预措施
Trabectedin+ PLD
Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), according to SmPC.
干预措施: Trabectedin and Pegylated Liposomal Doxorubicin (Drug)
结局指标
主要结局
Efficacy progression-free survival (PFS)
时间窗: Up to 12 months
Describe the impact of trabectedin - pegylated liposomal doxorubicin combination of retreatment with platinum ROC, in terms of progression-free survival ( PFS).
Overall survival (OS)
时间窗: Up to 12 months
Describe the impact of trabectedin - pegylated liposomal doxorubicin combination of retreatment with platinum ROC, in terms of overall survival (OS ) .
次要结局
- Hypersensitivity and allergic reactions (Number and Management of hypersensitivity reactions or allergies)(Up to 12 months)
- Response rate to previous and post-treatment (Percentage of responses (CR+PR)(Up to 12 months)
- Comparison between PFS and PFS2(Up to 12 months)
- Toxicity (adverse events)(Up to 12 months)
- Response rate to trabectedin - DLP combination (Percentage of responses (CR+PR)(Up to 12 months)
- Clinical Benefit in 4 months (Percentage of clinical benefit (CR + PR + SD)(Up to 12 months)
- Impact of trabectedin - PLD combination in subsequent treatments(Up to 12 months)