Retrospective Study in Sarcoma Patients

Completed

• Conditions: Sarcoma of Bone; Sarcoma of Soft Tissue

• Registration Number: NCT03284320
• Lead Sponsor: University Medicine Greifswald

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-18
• Study First Submitted: 2017-08-21
• Study First Submitted QC: 2017-09-12
• Study First Posted: 2017-09-15
• Primary Completion: 2019-12-31
• Status Verified: 2021-11
• Study Completion: 2021-11-01
• Last Update Submitted: 2021-11-05
• Last Update Posted: 2021-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 514

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- 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

Name	Time	Method
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

Trial Locations

Locations (1)

University Medicine Greifswald, Department of Internal Medicine C; 🇩🇪 Greifswald, Germany