This is a biology driven, monocentric study, designed to identify biomarkers of activity of trabectedin in patients with advanced non-L soft-tissue sarcoma. The aim of this study is to implement high-throughput profiling technologies to identify predictive biomarkers of trabectedin efficacy through sequential tumor biopsies and blood sample collection in sarcoma patients.
The identification of predictive biomarkers of the clinical benefit of trabectedin is a crucial issue to identify potential responders particularly for non-L sarcomas. Considering that the molecular profile of STS can change over time, an analysis of archival tumor material may not be a reliable method to identify predictive biomarkers of response, and thus high-throughput technologies may be promising to identify STS markers for prediction of response to trabectedin. For study purpose, blood and tumor samples will be obtained for genetic and immunological profiling at baseline, during treatment by trabectedin and at disease progression.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
200
\- Trabectedin will be prescribed as per market authorization and will be administered by intraveinous infusion (1,5 mg/m²) every 3 weeks. A treatment cycle is defined as a 3-weeks period
Institut Bergonie
Bordeaux, France
Efficacy of trabectedin: objective response [OR] or stable disease [SD] > 6 months
Efficacy of trabectedin is defined as objective response \[OR\] or stable disease \[SD\] \> 6 months. Absence of efficacy is defined as progressive disease \[PD\] within 2 months.
Time frame: Throughout the treatment period, an expected average of 6 months
Safety profile of trabectedin: Common Terminology Criteria for Adverse Events version 5
Toxicity graded using the Common Terminology Criteria for Adverse Events version 5.
Time frame: Throughout the treatment period, an expected average of 6 months
Safety profile of biopsy: Common Terminology Criteria for Adverse Events version 5
Toxicity graded using the Common Terminology Criteria for Adverse Events version 5.
Time frame: Throughout the treatment period, an expected average of 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.