Clinical trial · Observational
Geriatric Assessmen of Elderly "Unsuited" Patients Receiving Trabectedin in First Line Treatment For Advanced Soft Tissue Sarcomas (STS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Soft-tissue Sarcoma | Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
| Metastatic Soft-tissue Sarcoma | Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Treatment Group
- description
- 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.
- interventionNames
- Other: No Intervention
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 12 month after LPFV
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available