NCT02509234Unknown不适用
Trabectedin and Irinotecan in Pediatric Refractory Sarcomas
Technical University of Munich0 个研究点目标入组 30 人开始时间: 2014年2月最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- Toxicity during therapy
研究概览
简要总结
The purpose of the study is to evaluate patients with refractory childhood sarcomas, who have been treated with a combination therapy of trabectedin and irinotecan (within compassionate use), to determine, if this is a promising treatment option with acceptable toxicity and if the results warrant a prospective study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 10 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents and young adults (age10 - 40 yoa) with refractory sarcoma, for which there are presently no further treatment options in EURO-Ewing/ EURAMOS/CWS (i.e. ≥ second relapse in ES, resistance to surgery in osteosarcoma, relapsed rhabdomyosarcoma) and have been treated with a combined chemotherapy of trabectedin and irinotecan (described in intervention)
- •existing matched control in existing study databases
- •have started of treatment within three months of last progress
排除标准
- •Patients newly diagnosed or in first relapse.
结局指标
主要结局
Toxicity during therapy
时间窗: As long as patient is undergoing therapy/ 6 months
WHO toxicity grading
次要结局
- Quality of life(12 months)
- Assessment of therapeutic effect(12 months)
- Assessment of time to treatment failure(12 months)
研究者
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