Interest of Peri Operative CHemotherapy In Patients With CINSARC High-risk Localized Soft Tissue Sarcoma

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 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.

NCT Number	NCT04307277
Lead Sponsor	Institut Claudius Regaud
Conditions	Soft Tissue Sarcoma
Enrollment	600 participants
Start Date	2020-10-09
Primary Completion	2032-10 (estimated)
Study Completion	2032-10 (estimated)
Updated on ClinicalTrials.gov	2026-04-14