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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-02

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Advanced Soft-tissue Sarcoma Metastatic Soft-tissue Sarcoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment Group

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.

No Intervention

Intervention Type OTHER

This is a NIS. No intervention.

Interventions

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No Intervention

This is a NIS. No intervention.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No