At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed soft-tissue sarcoma by RRePS network
- ✓FNCLCC grade 1, 2, or 3
- ✓Resectable and localized disease after appropriate extension work-up including chest-CT
- ✓6 weeks or less between surgical excision and inclusion
- ✕Specific 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 except surgical excision
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Interest of Peri Operative CHemotherapy In Patients With CINSARC High-risk Localized Soft Tissue Sarcoma
In Brief
A Phase 3 clinical trial evaluating Standard of care + chemotherapy and Standard of care for Soft Tissue Sarcoma. Currently recruiting, targeting 600 participants across 19 sites.
Detailed 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 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.
Study Details
Timeline
Interventions
Doxorubicine with Ifosfamide during 4 cycles Q3W Or Doxorubicine with Dacarbazine during 4 cycles Q3W (for patients with Leiomyosarcoma)
Surgical excision with external radiotherapy (if applicable)