Advanced Soft-tissue Sarcoma, Metastatic Soft-tissue Sarcoma
Conditions
Keywords
soft tissue sarcomas (STS), trabectedin, metastatic STS patients, overall survival
Brief summary
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.
Interventions
OTHERNo Intervention
This is a NIS. No intervention.
Sponsors
GWT-TUD GmbH
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 1.1. (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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 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. |
Countries
Austria, Germany, Switzerland
Outcome results
None listed