Geriatric Assessmen of Elderly "Unsuited" Patients Receiving Trabectedin in First Line Treatment For Advanced Soft Tissue Sarcomas (STS)

Completed

• Conditions: Metastatic Soft-tissue Sarcoma; Advanced Soft-tissue Sarcoma
• Interventions: Other: No Intervention

• Registration Number: NCT03022448
• Lead Sponsor: GWT-TUD GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-13
• Study First Submitted QC: 2017-01-13
• Study First Posted: 2017-01-16
• Study Start: 2017-02-02
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-01
• Last Update Posted: 2022-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment Group	No Intervention	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (12)

HELIOS Klinikum Bad Saarow; 🇩🇪 Bad Saarow, Germany

HELIOS Klinikum Berlin Buch; 🇩🇪 Berlin, Germany

Klinikum Spandau; 🇩🇪 Berlin, Germany

Universitätsklinikum Ulm; 🇩🇪 Ulm, Germany

Klinikum Nürnberg Nord; 🇩🇪 Nürnberg, Germany

Medizinische Universität Wien; 🇦🇹 Wien, Austria

Universitätsspital Bern; 🇨🇭 Bern, Switzerland

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Kantonsspital St. Gallen; 🇨🇭 Saint Gallen, Switzerland

Universitätsklinikum Carl Gustav Carus der TU Dresden; 🇩🇪 Dresden, Germany

Klinikum Klagenfurt am Wörthersee; 🇦🇹 Klagenfurt, Austria

University of Heidelberg Mannheim University Medical Center Interdisciplinary Tumor Center, Sarcoma Unit; 🇩🇪 Mannheim, Germany