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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-27

Study Completion Date

2030-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Addition of postoperative chemotherapy to prevent or delay recurrence in patients newly diagnosed with localized uterine leiomyosarcoma and who have undergone complete tumor surgery.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

CytoreductiveSurgery & HIPEC w/Gemcitabine+Chemotherapy w/Dacarbazine in Uterine Leiomyosarcoma

NCT04727242

LMS - Leiomyosarcoma Uterine Leiomyosarcoma

ACTIVE_NOT_RECRUITING PHASE2

Molecular and Epidemiological Characteristics of Endometrial Cancer in Brazil

NCT06014580

Endometrial Cancer

ACTIVE_NOT_RECRUITING

Evaluation of Sentinel Node Policy in Early Stage Endometrial Carcinomas at Intermediate and High Risk of Recurrence.

NCT02598219

Non Endometrioid Carcinoma Endometrioid Carcinoma

ACTIVE_NOT_RECRUITING PHASE3

Contribution of Oncovascular Surgery in the Treatment of Gynecological Advanced Malignant Diseases.

NCT07267780

Ovarian Carcinoma Cervical Carcinoma Endometrial Carcinoma +3 more

NOT_YET_RECRUITING

Retrospective Study to Evaluate the Feasibility of Ovarian Preservation in Patients With Endometrial Carcinoma

NCT01560026

Endometrial Cancer

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a biological driven study comprising:

* a multicenter, randomized and comparative phase II trial designed to demonstrate whether adding 4 cycles of post-operative chemotherapy improves relapse-free survival as compared with follow-up (standard management) in patients with resected FIGO stage I uterine leiomyosarcoma, considered at high-risk according to CINSARC NanoCind® signature.
* a prospective cohort for patients with resected FIGO stage I uterine leiomyosarcoma, considered at low-risk according to CINSARC NanoCind® signature.

HIGH-RISK (HR) CINSARC patients will be randomized post-operatively between the two arms of treatment, i.e. standard treatment (active post-surgical surveillance) or chemotherapy, with a 1:1 randomization on one factor: morcellation versus no morcellation of uterine tumor.

LOW-RISK (LR) CINSARC patients' data will be prospectively collected

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Leiomyosarcoma Uterus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicenter, randomized and comparative phase II trial and prospective cohort

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm A

Standard of care : Active surveillance

Group Type NO_INTERVENTION

No interventions assigned to this group

Arm B

Experimental treatment: 4 cycle of Doxorubicine + trabectedin

Group Type EXPERIMENTAL

Doxorubicin

Intervention Type DRUG

60 mg/m² intravenous (IV) at Day 1 every 3 weeks (4 cycles)

Trabectedin

Intervention Type DRUG

1.1 mg/m² intravenous (IV) at Day 1 every 3 weeks (4 cycles)

Prospective Cohort

Standard of care : Active surveillance

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Doxorubicin

60 mg/m² intravenous (IV) at Day 1 every 3 weeks (4 cycles)

Intervention Type DRUG

Trabectedin

1.1 mg/m² intravenous (IV) at Day 1 every 3 weeks (4 cycles)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Yondelis

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

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

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.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Florence DUFFAUD, MD

Role: PRINCIPAL_INVESTIGATOR

La TIMONE University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.