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

April 1, 2022 updated by: GWT-TUD GmbH

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Klagenfurt, Austria
        • Klinikum Klagenfurt Am Worthersee
      • Wien, Austria
        • Medizinische Universitat Wien
  • Germany
      • Bad Saarow, Germany
        • HELIOS Klinikum Bad Saarow
      • Berlin, Germany
        • HELIOS Klinikum Berlin Buch
      • Berlin, Germany
        • Klinikum Spandau
      • Dresden, Germany
        • Universitätsklinikum Carl Gustav Carus der TU Dresden
      • Heidelberg, Germany
        • Universitätsklinikum Heidelberg
      • Mannheim, Germany
        • University of Heidelberg Mannheim University Medical Center Interdisciplinary Tumor Center, Sarcoma Unit
      • Nürnberg, Germany
        • Klinikum Nurnberg Nord
      • Ulm, Germany
        • Universitätsklinikum Ulm
  • Switzerland
      • Bern, Switzerland
        • Universitätsspital Bern
      • Saint Gallen, Switzerland
        • Kantonsspital St. Gallen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Elderly patients with advanced and/or metastatic STS (≥ 60 years including a maximum of 1/6 of "unsuited" patients younger than 60 years)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: No Intervention
This is a NIS. No intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 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.
12 month after LPFV

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GWT-TUD GmbH

Investigators

  • Principal Investigator: Bernd Kasper, Prof., University of Heidelberg Mannheim University Medical Center Interdisciplinary Tumor Center, Sarcoma Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 2, 2017

Primary Completion (ACTUAL)

December 31, 2021

Study Completion (ACTUAL)

December 31, 2021

Study Registration Dates

First Submitted

January 13, 2017

First Submitted That Met QC Criteria

January 13, 2017

First Posted (ESTIMATE)

January 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 4, 2022

Last Update Submitted That Met QC Criteria

April 1, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-Trab

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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