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.
Diagnosis of soft-tissue sarcoma, histologically confirmed by RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères) network
According to FNCLCC grading system, grade 1, 2 or 3 tumors
Resectable and localized disease after appropriate extension work-up (including at least a chest-CT)
6 weeks or less between surgical excision and inclusion (if performed before inclusion)
Soft-tissue sarcoma with the following histological subtypes: well-differentiated liposarcomas, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clear-cell sarcoma, epithelioid sarcoma, alveolar or embryonal rhabdomyosarcoma
Primitive cutaneous, retroperitoneal, uterus or visceral STS
Metastatic disease
Previous or ongoing treatment for the sarcoma (with the exception of surgical excision)