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

PHASE3RecruitingINTERVENTIONAL
Enrollment

351

Participants

Timeline

Start Date

February 14, 2019

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2028

Conditions
Non-metastatic Soft-tissue SarcomaResectable
Interventions
DRUG

Doxorubicin

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.

DRUG

Ifosfamide 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.

DRUG

Doxorubicin

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.

DRUG

Ifosfamide 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.

DRUG

At the discretion of the investigator

Drug at the discretion of the investigator.

Trial Locations (10)

13273

RECRUITING

Institut Paoli Calmettes, Marseille

21079

RECRUITING

Centre Georges François Leclerc, Dijon

31052

RECRUITING

Institut Claudius Regaud, Toulouse

33076

RECRUITING

Institut Bergonie, Bordeaux

34298

RECRUITING

Insitut du Cancer, Montpellier

44805

RECRUITING

Institut de Cancérologie de l'Ouest - Site René Gauducheau, Saint-Herblain

67200

RECRUITING

CHRU Strasbourg, Strasbourg

69373

RECRUITING

Centre Léon Bérard, Lyon

87042

RECRUITING

CHU Dupuytren, Limoges

94800

NOT_YET_RECRUITING

Institut Gustave Roussy, Villejuif

Sponsors
All Listed Sponsors
collaborator

Novartis

INDUSTRY

collaborator

Chugai Pharma France

INDUSTRY

lead

Institut Bergonié

OTHER