Status:

TERMINATED

Prospective Study to Evaluate Patient Reported Outcomes (PRO) During Rechallenge With Trabectedin in Sarcoma Patients

Lead Sponsor:

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Collaborating Sponsors:

PharmaMar

Conditions:

Soft Tissue Sarcoma

Eligibility:

All Genders

18+ years

Brief Summary

Chemotherapy with Trabectedin is an effective treatment for sarcoma patients in the second line setting or in first line for patients who are deemed unsuitable to receive anthracycline therapy. The pr...

Detailed Description

Chemotherapy with Trabectedin is an effective treatment for sarcoma patients in the second line setting or in first line for patients who are deemed unsuitable to receive anthracycline therapy. Severa...

Eligibility Criteria

Inclusion

  • Enrolled participant of the GISAR registry and their sub-studies
  • Patient with histologically confirmed soft tissue sarcomas
  • Pretreatment with Trabectedin, termination of this therapy regardless of reason
  • Planned rechallenge or started rechallenge with Trabectedin in any line of therapy within 2 weeks before inclusion
  • Interval between last Trabectedin treatment and Trabectedin rechallenge at least 3 months

Exclusion

  • Not able to understand all implications of study participation
  • No written informed consent
  • Age ≤ 18 years

Key Trial Info

Start Date :

October 31 2023

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

July 30 2024

Estimated Enrollment :

7 Patients enrolled

Trial Details

Trial ID

NCT06050434

Start Date

October 31 2023

End Date

July 30 2024

Last Update

December 1 2025

Active Locations (9)

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Page 1 of 3 (9 locations)

1

HELIOS KLinikum Bad Saarow

Bad Saarow, Germany

2

HELIOS Klinikum Berlin Buch

Berlin, Germany

3

Frankfurt Universitätsklinikum

Frankfurt am Main, Germany

4

Universitätsmedizin Göttingen

Göttingen, Germany

Prospective Study to Evaluate Patient Reported Outcomes (PRO) During Rechallenge With Trabectedin in Sarcoma Patients | DecenTrialz