Retrospective Study in Sarcoma Patients

Sarcoma of Bone Clinical Trial

— ReTraSarc  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03284320
• Other study ID #: GISG-14
• Status: Completed
• Start date: April 18, 2017
• Est. completion date: November 1, 2021

Study information

• Verified date: November 2021
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 514
• Est. completion date: November 1, 2021
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma
• Sarcoma of Bone
• Sarcoma of Soft Tissue

Locations

Country	Name	City	State
Germany	University Medicine Greifswald, Department of Internal Medicine C	Greifswald

Sponsors (2)

Lead Sponsor	Collaborator
University Medicine Greifswald	PharmaMar

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Pink D, Bertz-Lepel J, Busemann C, Bitz U, Reichardt P. Efficacy of trabectedin in patients with advanced or metastatic alveolar soft-part sarcoma. Onkologie. 2012;35(5):249-52. doi: 10.1159/000338342. Epub 2012 Apr 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Progression free survival (PFS)		At the time of every treatment documentation up to the end of treatment, approximately 2 years
Primary	- Overall survival (OS)		At the time of every treatment documentation up to the end of treatment, approximately 2 years
Secondary	CTCAE (Common Terminology Criteria for Adverse Events) 4.03	Safety Evaluation according to toxitiy	At the time of every treatment documentation up to the end of treatment, approximately 2 years