Non Interventional Study Dealing With the Use of Trabectedin (Yondelis®)-Pegylated Liposomal Doxorubicin (Caelyx®) in Patient With Platinum-sensitive Relapse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 33
- 主要终点
- Evaluate the proportion of patient partially versus fully platinum-sensitive in relapse ovarian cancer
研究概览
简要总结
The French cooperative group GINECO proposes to implement an observational study to describe a real situation, in daily practice tolerance and methods of administration of trabectedin (Yondelis®)-Pegylated liposomal doxorubicin(Caelyx)®, in ovarian platinum sensitive cancer relapse.
详细描述
Population : Patients aged 18 years and older with an epithelial ovarian cancer, fallopian tube or primary peritoneal with platinum-sensitive recurrent witch it was decided to initiate a treatment with trabectedin (Yondelis®)-Pegylated liposomal doxorubicin(Caelyx)®.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years and over,
- •Patients with an epithelial ovarian cancer, fallopian tube or peritoneal who will receive Yondelis®-Caelyx® in relapse platinum-sensitive
- •Patients should be informed of the study orally and should not have any objection their data to be processed
排除标准
- •Patient participation in a clinical trial
- •Patient non-affiliated to a social security scheme.
研究组 & 干预措施
Yondelis®-Caelyx®-relapse ovarian cancer
Yondelis®-Caelyx®-relapse ovarian cancer
干预措施: Yondelis®-Caelyx® (Drug)
结局指标
主要结局
Evaluate the proportion of patient partially versus fully platinum-sensitive in relapse ovarian cancer
时间窗: Patient will be followed during 12 months
To assess patient safety and the tolerance of Yondelis®-Caelyx® administered regarding the daily practice of the oncologist.
次要结局
- Safety according to CTCAE v4.03 criteria(Patient will be followed during 12 months)
- Evaluation of clinical benefit(baseline and during treatment (expected period of treatment = 6 months). As it is an non interventionnal study, treatment period corresponds to the routine practice of each investigator.)
- Characteristics of the population registered(at baseline)
- Choice of treatment(at baseline)
- Evaluation of the modality of use of Yondelis®-Caelyx®(during treatment (expected period = 6 months)-As it is an non interventionnal study, treatment period corresponds to the routine practice of each investigator)
- Efficacy of treatments(during treatment and follow up period (maximum of 12 months))