Overview

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

Status:
Recruiting
Trial end date:
2025-02-01
Target enrollment:
Participant gender:
Summary
The primary objective of this trial is to investigate whether the addition of 3 additional neo-adjuvant cycles of chemotherapy (doxorubicin and ifosfamide) to standard management according to the ISG-STS 10-01 study (3 cycles of neoadjuvant doxorubicin and ifosfamide 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).
Phase:
Phase 3
Details
Lead Sponsor:
Institut BergoniƩ
Collaborators:
Chugai Pharma France
Novartis
Treatments:
Doxorubicin
Ifosfamide
Isophosphamide mustard
Liposomal doxorubicin