Retrospective Study in Sarcoma Patients (ReTraSarc)

November 5, 2021 updated by: University Medicine Greifswald

Retrospective Study to Evaluate Efficacy and Safety of Trabectedin (Yondelis®) in Sarcoma Patients

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

514

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

  • Germany
      • Greifswald, Germany, 17475
        • University Medicine Greifswald, Department of Internal Medicine C

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with soft tissue and bone sarcomas treated with Trabectedin

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
- Progression free survival (PFS)
Time Frame: At the time of every treatment documentation up to the end of treatment, approximately 2 years
At the time of every treatment documentation up to the end of treatment, approximately 2 years
- Overall survival (OS)
Time Frame: At the time of every treatment documentation up to the end of treatment, approximately 2 years
At the time of every treatment documentation up to the end of treatment, approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CTCAE (Common Terminology Criteria for Adverse Events) 4.03
Time Frame: At the time of every treatment documentation up to the end of treatment, approximately 2 years
Safety Evaluation according to toxitiy
At the time of every treatment documentation up to the end of treatment, approximately 2 years

Collaborators and Investigators

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

Sponsor

University Medicine Greifswald

Collaborators

PharmaMar

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 18, 2017

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

November 1, 2021

Study Registration Dates

First Submitted

August 21, 2017

First Submitted That Met QC Criteria

September 12, 2017

First Posted (Actual)

September 15, 2017

Study Record Updates

Last Update Posted (Actual)

November 15, 2021

Last Update Submitted That Met QC Criteria

November 5, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GISG-14

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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