Interest of Post-operative Chemotherapy in Patients With Localised Uterine Leiomyosarcoma Suspected of Having a High Risk of Recurrence Based on a Biological Test Performed on the Tumour

Inclusion Criteria21

• Patient must have a histologically confirmed diagnosis of uterine leiomyosarcoma obtained less than 8 weeks from the surgery
• Eastern cooperative oncology group (ECOG) performance status (PS) 0 or 1
• Patient was previously untreated with chemotherapy for a sarcoma, and did not receive anthracyclines and/or trabectedin for another cancer
• Available Formalin Fixed Paraffin Embedded (FFPE) tumor blocks in sufficient quantity and quality to allow CINSARC NanoCind® qualification (low-risk or high-risk)
• Age ≥ 18 years and ≤ 75 years
• FIGO 2018 classification stage I (IA and IB), with complete resection (total hysterectomy and optional bilateral oophorectomy; possible ovarian preservation is feasible in selected cases)
• No measurable disease, as assessed by the investigator: normal post-operative thoracic, abdominal and pelvic CT-scan or normal MRI of abdomen and pelvis + normal chest CT performed within 4 weeks prior to inclusion or randomization in the study
• Signed informed consent form prior to any trial specific procedures consistent with international conference on harmonisation - good clinical practice (ICH-GCP) and local legislation
• Patient must be affiliated to a social security system or in possession of equivalent private health insurance (according to local regulations for participation in clinical trials).
• High-risk CINSARC signature
• Patient must have a diagnosis of uterine leiomyosarcoma confirmed by a local sarcoma expert pathologist from RRePS (Sarcoma Pathology Reference Network from NETSARC +) locally or by the study central RRePS expert pathologist.
• Adequate hematologic organ function:
• absolute neutrophil count ≥ 1.5 Giga/ L
• hemoglobin ≥ 9 g/dL
• platelets ≥ 100 Giga/L
• Adequate renal function: serum creatinine ≤ 1.5 mg/dL (≤ 132.6 µmol/L) or calculated creatinine clearance ≥60 mL/min (by the Cockcroft and Gault formula)
• Adequate liver function: total bilirubin ≤ upper limit of normal (ULN), transaminases ≤ 2.5 x ULN, alkaline phosphatases ≤ 1.5 x ULN
• Adequate cardiac function: cardiac ultrasound and/or isotopic ventriculography, shortening fraction (SF) \> 30%, Left Ventricular Ejection Fraction (LVEF) (per ultrasound or scintigraphy) \> 50%
• Creatine phosphokinase (CPK) ≤ 2,5 x ULN
• Albumin ≥ 25 g/L
• Signed informed consent form for the randomized phase, consistent with ICH-GCP and local legislation.