Retrospective Study in Sarcoma Patients

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03284320

Acronym

ReTraSarc

Enrollment

514

Registered

2017-09-15

Start date

2017-04-18

Completion date

2021-11-01

Last updated

2021-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoma of Bone, Sarcoma of Soft Tissue

Keywords

Drug therapy, Treatment outcome, Adult

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
- 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

Measure	Time frame	Description
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

Countries

Germany

Outcome results