NCT04307277

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Institut Claudius Regaud · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Standard of care + chemotherapy	Doxorubicine with Ifosfamide during 4 cycles Q3W Or Doxorubicine with Dacarbazine during 4 cycles Q3W (for patients with Leiomyosarcoma)
OTHER	Standard of care	Surgical excision with external radiotherapy (if applicable)

Timeline

• Start date: 2020-10-09
• Primary completion: 2032-10-01
• Completion: 2032-10-01
• First posted: 2020-03-13
• Last updated: 2026-04-14

Locations

19 sites across 1 country: France