Geriatric Assessmen of Elderly "Unsuited" Patients Receiving Trabectedin in First Line Treatment For Advanced Soft Tissue Sarcomas (STS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- GWT-TUD GmbH
- 入组人数
- 72
- 试验地点
- 12
- 主要终点
- Overall survival
研究概览
简要总结
The aim of the non-interventional study is to prospectively collect and analyze data on the geriatric assessment of patients undergoing systemic 1st line therapy with trabectedin with focus on patients who have been assessed by the treating physician as being unsuited to receive standard chemotherapy with anthracyclines and / or ifosfamide.
Trabectedin will be used according to the local SmPC. Modification of the treatment schedule should follow the standard medical practice at the discretion of the treating physician and is not part of this Observational Plan.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Age of ≥ 60 years at study inclusion with a limited number of "unsuited" patients younger than 60 years
- •Histologically proven advanced and/or metastatic STS, intermediate/high grade
- •Presence of measurable disease according to RECIST 1.
- •(optional, according to local clinical practice)
- •Patients indicated for 1st line treatment with trabectedin according to local SmPC
- •ECOG Performance Status 0, 1 or 2
- •bone marrow function according to local SmPC
- •hepatic function according to local SmPC
- •Ability to understand and follow study-related instructions
排除标准
- •Histologically proven advanced and/or metastatic STS of the following tumor types:
- •Embryonal rhabdomyosarcoma
- •Chondrosarcoma (excluding extraskeletal myxoid chondrosarcoma)
- •Osteosarcoma (excluding extraskeletal osteosarcoma)
- •Ewing tumors/primitive neuroectodermal tumor
- •Gastrointestinal stromal tumors
- •Dermatofibrosarcoma protuberans
- •Use of any investigational agent within 28 days prior to treatment start
- •Exclusion periods from other studies or simultaneous participation in other clinical studies
- •Contraindications according to the local SmPC of Yondelis® (see Appendix A)
- •Subject is in custody by order of an authority or a court of law
- •Previous assignment to the E-Trab study (An individual subject may only be included once in the study)
- •Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety
结局指标
主要结局
Overall survival
时间窗: 12 month after LPFV
Overall survival for each patient will be followed until the end of the study that is defined by 12 months after inclusion of the last patient.
次要结局
未报告次要终点