ReTraSarc: Retrospective Study in Sarcoma Patients

Sponsor
University Medicine Greifswald (Other)
Overall Status
Completed
CT.gov ID
NCT03284320
Collaborator
PharmaMar (Industry)
514
1
54.5
9.4

Study Details

Study Description

Brief Summary

The objectives of this trial is to evaluate efficacy and safety of treatment with Trabectedin in a large cohort of German patients with soft tissue and bone sarcomas.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    514 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Retrospective Study to Evaluate Efficacy and Safety of Trabectedin (Yondelis®) in Sarcoma Patients
    Actual Study Start Date :
    Apr 18, 2017
    Actual Primary Completion Date :
    Dec 31, 2019
    Actual Study Completion Date :
    Nov 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. - Progression free survival (PFS) [At the time of every treatment documentation up to the end of treatment, approximately 2 years]

    2. - Overall survival (OS) [At the time of every treatment documentation up to the end of treatment, approximately 2 years]

    Secondary Outcome Measures

    1. CTCAE (Common Terminology Criteria for Adverse Events) 4.03 [At the time of every treatment documentation up to the end of treatment, approximately 2 years]

      Safety Evaluation according to toxitiy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with histologically confirmed soft tissue or bone sarcomas treated with at least one cycle of Trabectedin in any line of therapy.

    • Age ≥18years at start of therapy with Trabectedin

    • Informed Consent

    • Patients already deceased may be included when the treating physician is able to determine the presumptive consent

    Exclusion Criteria:
    • No follow-up data available

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Medicine Greifswald, Department of Internal Medicine C Greifswald Germany 17475

    Sponsors and Collaborators

    • University Medicine Greifswald
    • PharmaMar

    Investigators

    • Principal Investigator: Daniel Pink, MD, University Medicine Greifswald
    • Principal Investigator: Peter Reichardt, MD, Sarcoma Center Berlin-Brandenburg; HELIOS Hospital Berlin Buch

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University Medicine Greifswald
    ClinicalTrials.gov Identifier:
    NCT03284320
    Other Study ID Numbers:
    • GISG-14
    First Posted:
    Sep 15, 2017
    Last Update Posted:
    Nov 15, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Medicine Greifswald
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 15, 2021