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

Advanced Soft-tissue Sarcoma Clinical Trial

— E-TRAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03022448
• Other study ID #: E-Trab
• Status: Completed
• Start date: February 2, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2022
• Source: GWT-TUD GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Soft-tissue Sarcoma
• Metastatic Soft-tissue Sarcoma
• Sarcoma

Intervention

Other:
• No Intervention
This is a NIS. No intervention.

Locations

Country	Name	City	State
Austria	Klinikum Klagenfurt am Wörthersee	Klagenfurt
Austria	Medizinische Universität Wien	Wien
Germany	HELIOS Klinikum Bad Saarow	Bad Saarow
Germany	HELIOS Klinikum Berlin Buch	Berlin
Germany	Klinikum Spandau	Berlin
Germany	Universitätsklinikum Carl Gustav Carus der TU Dresden	Dresden
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	University of Heidelberg Mannheim University Medical Center Interdisciplinary Tumor Center, Sarcoma Unit	Mannheim
Germany	Klinikum Nürnberg Nord	Nürnberg
Germany	Universitätsklinikum Ulm	Ulm
Switzerland	Universitätsspital Bern	Bern
Switzerland	Kantonsspital St. Gallen	Saint Gallen

Sponsors (1)

Lead Sponsor	Collaborator
GWT-TUD GmbH

Countries where clinical trial is conducted

Austria,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	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.	12 month after LPFV