Interest of Peri Operative CHemotherapy In Patients With CINSARC High-risk Localized Grade 1 or 2 Soft Tissue Sarcoma
Status:
Recruiting
Trial end date:
2025-03-01
Target enrollment:
Participant gender:
Summary
Phase III, multicenter, randomized open-label and comparative study designed to demonstrate
whether adding 4 cycles of peri-operative doxorubicin-based chemotherapy improves
metastasis-free survival as compared with standard management in patients with resectable
FNCLCC grade 1/2 STS, considered as high-risk according to CINSARC (Complexity Index in
SARComas) signature.
After signed informed consent, patients considered as eligible to CHIC-STS study by the
investigator will be enrolled in the study and a molecular screening will be performed (600
patients will be screened).
Patients considered as low-risk according to CINSARC signature will be treated at the
discretion of the clinicians (prospective cohort).
Patients considered as high-risk according to CINSARC signature will be randomized in the
open-label multicenter phase III trial and assigned in one of the two following treatments
arms:
- Arm A (control arm): Standard of care (surgical excision +/- external radiotherapy).
- Arm B (experimental arm): Standard of care + 4 cycles of intravenous chemotherapy during
12 weeks.
A total of 250 patients will have to be randomized with 125 patients in each arm.