Clinical Trial

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

Study acronym: CIRSARC
Recruiting Phase 3
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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).
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2019-01-14; most recent amendment 2025-10-01.
Status change: Not Yet Recruiting → Recruiting 2020-01-22
Trial Details
NCT Number NCT03805022
Lead Sponsor Institut Bergonié
Collaborators: Novartis, Chugai Pharma France
Conditions Non-metastatic Soft-tissue Sarcoma, Resectable
Enrollment 351 participants
Start Date 2019-02-14
Primary Completion 2026-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2025-10-02