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)
Parallel
Standard of care + chemotherapy
DrugDoxorubicine with Ifosfamide during 4 cycles Q3W Or Doxorubicine with Dacarbazine during 4 cycles Q3W (for patients with Leiomyosarcoma)
Standard of care
Other interventionSurgical excision with external radiotherapy (if applicable)
Metastasis-free survival defined by the delay between randomization and the appearance of metastatic.
Disease-free survival defined by the delay between randomization and first relapse (local, regional, or distant) or death from any cause.
Safety assessed by the toxicity grading of the National Cancer Institute (NCI-CTCAE v5.0).
Overall survival defined by the delay between randomization and death from any cause.
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