OncoMatch/Clinical Trials/NCT04307277
Interest of Peri Operative CHemotherapy In Patients With CINSARC High-risk Localized Soft Tissue Sarcoma
Is NCT04307277 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Standard of care + chemotherapy for soft tissue sarcoma.
Treatment: Standard of care + chemotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Disease stage
Grade: 123 (fnclcc)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: ifosfamide or cyclophosphamide or other nitrogen mustards (ifosfamide, cyclophosphamide)
Prior therapy with ifosfamide or cyclophosphamide or other nitrogen mustards
Cannot have received: anthracyclines
prior therapy with anthracyclines
Cannot have received: mediastinal/cardiac radiotherapy
Prior mediastinal/cardiac radiotherapy
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1.5 G/L, Platelet count ≥ 100 G/L and Hemoglobin > 9g/dL
Kidney function
Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 60 mL/min (by the Cockcroft and Gault formula)
Liver function
Bilirubin ≤ 1.5 x upper limit of normal (ULN), AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN
Cardiac function
Normal LVEF (>50%) measured by echocardiography or isotopic ventriculography
Acceptable hematologic function (within 72 hours prior randomization): Absolute neutrophil count (ANC) ≥ 1.5 G/L, Platelet count ≥ 100 G/L and Hemoglobin > 9g/dL; Acceptable renal function within 72 hours prior randomization: Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 60 mL/min (by the Cockcroft and Gault formula); Acceptable liver function: Bilirubin ≤ 1.5 x upper limit of normal (ULN), AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN; Normal LVEF (>50%) measured by echocardiography or isotopic ventriculography
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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