NCT03284320已完成不适用
Retrospective Study to Evaluate Efficacy and Safety of Trabectedin (Yondelis®) in Sarcoma Patients
University Medicine Greifswald1 个研究点 分布在 1 个国家目标入组 514 人开始时间: 2017年4月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 514
- 试验地点
- 1
- 主要终点
- - Progression free survival (PFS)
研究概览
简要总结
The objectives of this trial is to evaluate efficacy and safety of treatment with Trabectedin in a large cohort of German patients with soft tissue and bone sarcomas.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically confirmed soft tissue or bone sarcomas treated with at least one cycle of Trabectedin in any line of therapy.
- •Age ≥18years at start of therapy with Trabectedin
- •Informed Consent
- •Patients already deceased may be included when the treating physician is able to determine the presumptive consent
排除标准
- •No follow-up data available
结局指标
主要结局
- Progression free survival (PFS)
时间窗: At the time of every treatment documentation up to the end of treatment, approximately 2 years
- Overall survival (OS)
时间窗: At the time of every treatment documentation up to the end of treatment, approximately 2 years
次要结局
- CTCAE (Common Terminology Criteria for Adverse Events) 4.03(At the time of every treatment documentation up to the end of treatment, approximately 2 years)
研究者
研究点 (1)
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