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
- - Progression free survival (PFS) [At the time of every treatment documentation up to the end of treatment, approximately 2 years]
- - Overall survival (OS) [At the time of every treatment documentation up to the end of treatment, approximately 2 years]
Secondary Outcome Measures
- 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: