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RecruitingPhase 3NCT03805022

Benefit of Intensified Peri-operative Chemotherapy Within High-risk CINSARC Patients With Resectable Soft-tissue Sarcomas

Phase III Trial Investigating the Potential Benefit of Intensified Peri-operative Chemotherapy With in High-risk CINSARC Patients With Resectable Soft-tissue SARComas

Sponsor

Institut Bergonié

Enrollment

351 participants

Start Date

Feb 14, 2019

Study Type

INTERVENTIONAL

Conditions

Non-metastatic Soft-tissue SarcomaResectable

Summary

The primary objective of this trial is to investigate whether the addition of 3 additional neo-adjuvant cycles of chemotherapy (doxorubicin based chemotherapy) to standard management according to the ISG-STS 10-01 study (3 cycles of neoadjuvant doxorubicin based chemotherapy + surgery +/- radiotherapy) improves the outcome of high-risk CINSARC patients with resectable soft-tissue sarcoma (STS). Primary endpoint is metastatic progression-free survival (M-PFS, after 3 years of follow-up).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether giving extra (intensified) chemotherapy before and after surgery produces better outcomes for patients with a high-risk type of soft tissue sarcoma (a cancer that grows in muscles, fat, or connective tissue). **You may be eligible if...** - You are 18 years or older - You have been diagnosed with a Grade 2 or 3 soft tissue sarcoma that has been confirmed by a specialist pathology network - Your cancer has not spread to other parts of the body and can be surgically removed - You have not had any prior treatment for this cancer - You are in good physical condition (able to carry out light activity) - Your life expectancy is at least 3 months **You may NOT be eligible if...** - Your cancer has spread (metastatic) - You have already received treatment for this cancer - Your general health status is too poor to tolerate chemotherapy - Tumor tissue is not available for research purposes 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

DRUGDoxorubicin

A treatment cycle consists of 3 weeks. Doxorubicin will be administered from day 1 to day 3 (60 or 75mg/m² day or 20 or 25 mg/m² per day), repeated every 3 weeks, up to 3 cycles.

DRUGIfosfamide or dacarbazine

A treatment cycle consists of 3 weeks. Treatment may continue up to 3 cycles. Ifosfamide will be administered from day 1 to day 3 (7,5-9 g/m² over 3 days with mesna and G-CSF) or dacarbazine (100 mg/m² 1 day or 450 mg/m² 2 days) as per local practices, repeated every 3 weeks, up to 3 cycles.

DRUGDoxorubicin

A treatment cycle consists of 3 weeks. Doxorubicin will be administered from day 1 to day 3 (60 or 75mg/m² day or 20 or 25 mg/m² per day), repeated every 3 weeks, up to 6 cycles.

DRUGIfosfamide or dacarbazine

A treatment cycle consists of 3 weeks. Ifosfamide will be administered from day 1 to day 3 (7,5-9 g/m² over 3 days with mesna and G-CSF) or dacarbazine (100 mg/m² 1 day or 450 mg/m² 2 days) as per local practices, repeated every 3 weeks, up to 6 cycles.

DRUGAt the discretion of the investigator

Drug at the discretion of the investigator.

Locations(10)

Institut Bergonie

Bordeaux, France

Centre Georges François Leclerc

Dijon, France

CHU Dupuytren

Limoges, France

Centre Léon Bérard

Lyon, France

Institut Paoli Calmettes

Marseille, France

Insitut du Cancer

Montpellier, France

Institut de Cancérologie de l'Ouest - Site René Gauducheau

Saint-Herblain, France

CHRU Strasbourg

Strasbourg, France

Institut Claudius Regaud

Toulouse, France

Institut Gustave Roussy

Villejuif, France

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NCT03805022