Leiomyosarcoma UterusPhase 2L-UteCINNCT06524583

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

A Phase 2 study testing Doxorubicin and Trabectedin in people with Leiomyosarcoma Uterus, run by UNICANCER at 25 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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

Who is it for?: Ages 18 to 75 years, women only
Conditions the study is for: Leiomyosarcoma Uterus
What is being tested?: Doxorubicin and Trabectedin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 198 participants
Where: 25 sitesFrance
Study dates: 27 Jan 2025to Dec 2030
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

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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).
Additional inclusion criteria for randomization
Inclusion criteria checked at study entry are all still met at the time of randomization
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.

Who cannot join

All other histology types of uterine sarcoma (adenosarcoma, endometrial sarcoma, undifferentiated uterine sarcoma)
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
Planned pelvic post-operative radiation therapy
Metastatic or measurable disease on CT-Scan
Known hypersensitivity to doxorubicin or trabectedin or to any of the excipients
Any contra-indication for the use of doxorubicin and/or trabectedin treatment

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Participation in another therapeutic trial within the 30 days prior to inclusion in the study
Active viral hepatitis B or C or known human immunodeficiency virus (HIV) infection.
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)
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 :
Patient must have a diagnosis of uterine leiomyosarcoma confirmed by a sarcoma expert pathologist or by the study central pathologist
Patients with a low-risk CINSARC signature

Trial locations and contacts

25 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Amel MEKALICHE, MS contact

+33 761947045

a-mekaliche@unicancer.fr

City, postcode or hospital

Sites recruiting now only

25 sites in 1 country

France25 sites, 25 recruiting

Institut de Cancerologie de L'Ouest (Ico)
Angers, 49100
Patrick SOULIÉ, MD
Not yet recruiting
Hopital Jean Minjoz
Besançon, 25030
Loic CHAIGNEAU, MD
Not yet recruiting
Institut Bergonie
Bordeaux, 33076
Maud TOULMONDE, MD
Not yet recruiting
Centre Francois Baclesse
Caen, 14176
Zoé NEVIERE, MD
Not yet recruiting
Centre Jean Perrin
Clermont-Ferrand, 63011
Pascale DUBRAY-LONGERAS, MD
Not yet recruiting
Centre Georges Francois Leclerc
Dijon, 21079
Isabelle DESMOULINS, MD
Not yet recruiting
Chu Limoges
Limoges, 87042
Tiffany DARBAS, MD
Not yet recruiting
Centre Léon Berard
Lyon, 69373
Isabelle RAY-COCUARD, MD PhD
Not yet recruiting
Institut Paoli Calmettes
Marseille, 13273
François BERTUCCI, MD PhD
Not yet recruiting
La Timone University Hospital
Marseille, 13385
Florence DUFFAUD, MD PhD
Recruiting
Centre Antoine Lacassagne
Nice, 06189
Agnès DUCOULOMBIER, MD
Not yet recruiting
Hopital Saint Louis
Paris, 75010
Tiphaine LAMBERT, MD
Not yet recruiting
Hôpital Cochin
Paris, 75014
Sixtine DE PERCIN, MD
Not yet recruiting
Groupe Hospitalier Diaconesses Croix St Simon
Paris, 75020
Frédéric SELLE, MD
Not yet recruiting
Hopital Tenon
Paris, 75020
Laurent SEKNAZI, MD
Not yet recruiting
Institut Curie
Paris
Clément BONET, MD
Not yet recruiting
Chu de Poitiers
Poitiers, 86000
Nicolas ISAMBERT, MD PHD
Not yet recruiting
Centre Eugene Marquis
Rennes, 35042
Christophe PERRIN, MD
Not yet recruiting
Centre Henri Becquerel
Rouen, 76038
Cécile GUILLEMET, MD
Not yet recruiting
Institut de cancerologie de l'ouest site Rene Gauducheau
Saint-Herblain, 44805
Pierre KUBICEK, MD
Not yet recruiting
Institut de Cancerologie Strasbourg Europe (Icans)
Strasbourg
Jean-Emmanuel KURTZ, MD
Not yet recruiting
Institut Claudius Regaud
Toulouse, 31052
Thibaud VALENTIN, MD
Not yet recruiting
CHU Bretonneau
Tours, 37000
Mathilde CANCEL, MD
Not yet recruiting
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54519
Maria RIOS, MD
Not yet recruiting
Gustave Roussy
Villejuif, 94800
Patricia PAUTIER, MD
Recruiting

Other trials in France

About this study

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

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

Read the detailed description

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: Leiomyosarcoma Uterus
Being tested: Doxorubicin, Trabectedin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DoxorubicinDrug
60 mg/m² intravenous (IV) at Day 1 every 3 weeks (4 cycles)
TrabectedinDrug
Also called Yondelis
1.1 mg/m² intravenous (IV) at Day 1 every 3 weeks (4 cycles)

Study groups in NCT06524583
Study group	Role	What they receive
Arm A	No intervention	Standard of care : Active surveillance
Arm B	Experimental	Experimental treatment: 4 cycle of Doxorubicine + trabectedin Receives: Drug: Doxorubicin; Drug: Trabectedin
Prospective Cohort	No intervention	Standard of care : Active surveillance

What is being measured

The primary outcome is the main question the study is designed to answer.

Relapse-free survival
The relapse-free survival is defined as the time from the date of randomization assignment (or the date of enrollment for patients in the prospective cohort) to the date of first disease recurrence/relapse (local/regional recurrence and/or distant metastasis) or death from any cause whichever comes first.
Measured: From randomization or enrollment to disease recurrence or death, up to 5 years

Secondary outcomes (4)

Overall survival
The overall survival is the length of time from randomization (or enrollment for patients in the prospective cohort) that patients enrolled in the study are still alive.
Measured: From randomization or enrollment to death, up to 5 years
Metastases-free survival
The metastases-free survival is the length of time during and after the treatment for cancer that a patient is still alive and the cancer has not spread to other parts of the body.
Measured: From randomization or enrollment to metastases onset or death, up to 5 years
Incidence of adverse events
The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.
Safety and tolerability (NCI-CTCAE v5.0) will be assessed through the incidence of adverse events, treatment-related adverse events, serious adverse events (SAEs); and death.
Measured: Throughout study completion, up to 5 years
Quality of life questionnaire - Core 30 (QLQ-C30)
Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.
The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: At baseline, end of treatment (up to week 12), 4 months, 6 months, 1 year and 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jan 2025Dec 2030

First posted29 Jul 2024
Study start27 Jan 2025
Primary completionDec 2029 (estimated)
Study completionDec 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Leiomyosarcoma UterusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Multicenter, randomized and comparative phase II trial and prospective cohort
Masking: None (open label)
Enrolment: 198 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06524583
Sponsor's protocol ID: UC-SAR-2212
Other IDs: 2023-506350-21-00, 2023
Acronym: L-UteCIN
Status last verified: Aug 2026
First submitted: 23 Jul 2024
Last updated: 29 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.