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Post-operative chemotherapy for high-risk uterine leiomyosarcoma patients

Interest of Adjuvant Chemotherapy in Patients With CINSARC High-risk Localized Resected Uterine Leiomyosarcoma - Sarcome 15

Phase 2 Interventional Unicancer · NCT06524583

This study is testing if adding four cycles of chemotherapy after surgery can help high-risk uterine leiomyosarcoma patients stay cancer-free longer compared to just regular follow-up care.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment198 (estimated)
Ages18 Years to 75 Years
SexFemale
SponsorUnicancer Academic / other
Drugs / interventionschemotherapy, immunotherapy, radiation, doxorubicin
Locations25 sites (Angers and 24 other locations)
Trial IDNCT06524583 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of adding four cycles of post-operative chemotherapy to improve relapse-free survival in patients with localized uterine leiomyosarcoma who are at high risk of recurrence based on a biological test. The study is a multicenter, randomized phase II trial comparing the outcomes of chemotherapy versus standard follow-up care in patients who have undergone complete tumor resection. Additionally, it includes a prospective cohort of low-risk patients whose data will be collected for further analysis. The chemotherapy agents used in this trial are Doxorubicin and Trabectedin.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of FIGO stage I uterine leiomyosarcoma who have undergone complete surgical resection.

Not a fit: Patients with advanced disease or those who have previously received chemotherapy for sarcoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of cancer recurrence in high-risk patients after surgery.

How similar studies have performed: Previous studies have shown promising results with post-operative chemotherapy in similar sarcoma cases, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Patient must have a histologically confirmed diagnosis of uterine leiomyosarcoma obtained less than 8 weeks from the surgery
2. Eastern cooperative oncology group (ECOG) performance status (PS) 0 or 1
3. Patient was previously untreated with chemotherapy for a sarcoma, and did not receive anthracyclines and/or trabectedin for another cancer
4. Available Formalin Fixed Paraffin Embedded (FFPE) tumor blocks in sufficient quantity and quality to allow CINSARC NanoCind® qualification (low-risk or high-risk)
5. Age ≥ 18 years and ≤ 75 years
6. 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)
7. 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
8. Signed informed consent form prior to any trial specific procedures consistent with international conference on harmonisation - good clinical practice (ICH-GCP) and local legislation
9. 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).

   Additional inclusion criteria for randomization
10. Inclusion criteria checked at study entry are all still met at the time of randomization
11. High-risk CINSARC signature
12. 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.
13. Adequate hematologic organ function:

    * absolute neutrophil count ≥ 1.5 Giga/ L
    * hemoglobin ≥ 9 g/dL
    * platelets ≥ 100 Giga/L
14. 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)
15. Adequate liver function: total bilirubin ≤ upper limit of normal (ULN), transaminases ≤ 2.5 x ULN, alkaline phosphatases ≤ 1.5 x ULN
16. Adequate cardiac function: cardiac ultrasound and/or isotopic ventriculography, shortening fraction (SF) \> 30%, Left Ventricular Ejection Fraction (LVEF) (per ultrasound or scintigraphy) \> 50%
17. Creatine phosphokinase (CPK) ≤ 2,5 x ULN
18. Albumin ≥ 25 g/L
19. Signed informed consent form for the randomized phase, consistent with ICH-GCP and local legislation.

Exclusion Criteria:

* Exclusion criteria:

  1. All other histology types of uterine sarcoma (adenosarcoma, endometrial sarcoma, undifferentiated uterine sarcoma)
  2. Prior or concurrent malignant disease diagnosed or treated in the last 5 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma
  3. Planned pelvic post-operative radiation therapy
  4. Metastatic or measurable disease on CT-Scan
  5. Known hypersensitivity to doxorubicin or trabectedin or to any of the excipients
  6. Any contra-indication for the use of doxorubicin and/or trabectedin treatment
  7. Participation in another therapeutic trial within the 30 days prior to inclusion in the study
  8. Active viral hepatitis B or C or known human immunodeficiency virus (HIV) infection.
  9. Prior anticancer therapy, including radiotherapy, endocrine therapy, immunotherapy, chemotherapy (CT) or other investigational agents within the last 4 weeks (6 weeks for nitrosoureas and mitomycin C)
  10. Cardiovascular dysfunction:
* Congestive heart failure (New York Heart Association \[NYHA\]) ≥ 2)
* Myocardial infarction \<6 months before study
* Poorly controlled cardiac arrhythmias
* Uncontrolled hypertension
* Unstable (angina symptoms at rest) or new-onset angina (begun within the last 3 months) 11. Ongoing infection \> Grade 2 according to NCI-CTCAE v5.0 12. Breastfeeding woman 13. Patients unwilling or unable to comply with the medical procedures and follow-up required by the trial because of geographic, familial, social, or psychological reasons 14. Persons deprived of their liberty or under protective custody or guardianship.

Additional exclusion criteria for randomization 15. At least one of the exclusion criteria check at study entry is met at the time of randomization 16. Unknown risk for CINSARC signature 17. For patients who require a pathological review by the study central pathologist, failure to obtain a confirmed diagnosis at randomization 18. More than 13 weeks have elapsed since the surgery procedure. 19. Patient receiving phenytoin within 88 hours prior to randomisation and or live attenuated vaccines within 14 days prior to randomisation and or CYP3A4 inhibitors (e.g. oral ketoconazole, fluconazole, ritonavir, clarithromycin or aprepitant) and or strong CYP3A4 inducers (e.g. rifampicin, phenobarbital, St John's wort).

Criteria for continuing in the prospective cohort :

1. Patient must have a diagnosis of uterine leiomyosarcoma confirmed by a sarcoma expert pathologist or by the study central pathologist
2. Patients with a low-risk CINSARC signature

Where this trial is running

Angers and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Leiomyosarcoma Uterus
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.