An Observational, Multicenter, Open-label Study of YONDELIS®+PLD for the Treatment of Patients With Platinum-sensitive Relapse of Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- safety and tolerability data of the study therapy
研究概览
简要总结
Clinical trials are, due to the inclusion and exclusion criteria, accomplished with defined patient groups, which are not representative for the whole patient population.
Especially elderly patients and patients with co-morbidities are underrepresented in clinical trials.
This non-interventional study will examine the efficiency and toxicity of the Yondelis® + PLD combination therapy in a general patient population to evaluate if the data collected in the clinical trials can be assigned to a general patient population.
详细描述
Yondelis® (trabectedin) was approved (in combination with PLD) in the European community in December 2009 for the treatment of platinum-sensitive ovarian cancer relapse. Based on the outcomes of study OVA-301, this non-interventional study will investigate the role of a platinum-free treatment regimen in patients with progressive ovarian cancer relapsing > 6 months after completing previous platinum-based chemotherapy. In particular, this study aims at collecting the "real-life" data with regard to the response and the influence of the mentioned therapy on the "tumor related events", to objectify the value of palliative care.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Women age >18, no upper limit
- •Patients with relapsed platinum-sensitive ovarian cancer
- •Before inclusion in the NIS written informed consent must be given
排除标准
- •According to summary of product characteristics
结局指标
主要结局
safety and tolerability data of the study therapy
时间窗: during Yondelis-PLD-therapy
Number of patients with adverse events
次要结局
- Treatment duration(during Yondelis-PLD-therapy)
- Time to next treatment(1 Year after last Yondelis-PLD-Therapy)
- Progression free survival(till one year after last date of Yondelis-PLD-therapy)
- "Real life data" - clinical and / or serological (CA 125) response and Stable disease rates(till one year after last date of Yondelis-PLD-therapy)
- Observation of the number of the therapy cycles applied(during Yondelis-PLD-therapy)
- Duration of response(till one year after last date of Yondelis-PLD-therapy)