RecruitingNot ApplicableNCT02789384

CINSARC Signature and Correlation With Hemotherapy Efficacy in Soft-tissue Sarcomas. A Biomarker Study.

Prognostic Value of the CINSARC (Complexity Index in Sarcoma) Signature and Correlation With Chemotherapy Efficacy in Soft-tissue Sarcomas. A Biomarker Study. (NEOSarcomics )


Sponsor

Institut Bergonié

Enrollment

205 participants

Start Date

Jun 1, 2016

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective observational biomarker study including patients with non-metastatic, soft-tissue sarcomas (STS) for whom neoadjuvant chemotherapy is considered as the best option by the multidisciplinary sarcoma team of one of the participating centers.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a genetic test called the CINSARC signature — which looks at specific patterns of gene activity in a tumor — can predict which patients with soft tissue sarcoma (cancer of connective tissues like muscle or fat) will respond well to chemotherapy given before surgery. **You may be eligible if...** - You have been diagnosed with soft tissue sarcoma, confirmed by specialist pathology review - Your cancer has not spread to distant parts of the body - Your medical team recommends chemotherapy before surgery to shrink the tumor - You are 18 years or older and in good general health - You have frozen tumor tissue available, or you are willing to have a biopsy - Your cancer is measurable on imaging scans **You may NOT be eligible if...** - Your sarcoma has already spread elsewhere in the body - You are too unwell to receive chemotherapy - You are pregnant or breastfeeding - Your tumor was previously irradiated and is the only measurable site Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERProcedure/Surgery

Procedure/Surgery: Newly obtained biopsy if applicable and Blood samples collection. For each patient: * Frozen and paraffin embedded tumor material (archival or new biopsy) will be obtained for genetic profiling * Blood samples will be obtained for genetic profiling and assessment of markers. The classification as CINSARC will be performed for each patient. Patients should be treated by neoadjuvant anthracycline-based chemotherapy. Chemotherapy regimen must contain at least doxorubicin (dose range: 60 -75 mg/m²) and ifosfamide (dose range: 2.5-3g/m²) to be delivered on a 21-days cycle basis up to 6 cycles prior surgery. After neoadjuvant chemotherapy completion, patients will be treated by surgery followed or not by radiotherapy. All patients should be managed according to the usual medical practices.


Locations(10)

Institut Bergonié

Bordeaux, France

Centre Georges François Leclerc

Dijon, France

Centre Oscar Lambret

Lille, France

Centre Léon Bérard

Lyon, France

Institut Paoli Calmettes

Marseille, France

AP-HM _ Hôpital de la Timone

Marseille, France

Institut de Cancérologie de l'Ouest

Nantes, France

Institut Curie

Paris, France

Institut Claudius Regaud - IUCT-0

Toulouse, France

Institut Gustave Roussy

Villejuif, France

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NCT02789384


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