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

NCT06524583 | Recruiting Phase 2 DMC

• 2 other identifiers: UC-SAR-22122023-506350-21-00
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 25

Brief 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.

Conditions

Leiomyosarcoma Uterus

Outcome Measures

Primary Outcomes (1)

• 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.

  From randomization or enrollment to disease recurrence or death, up to 5 years

Secondary Outcomes (4)

• Overall survival

  From randomization or enrollment to death, up to 5 years

• Metastases-free survival

  From randomization or enrollment to metastases onset or death, up to 5 years

• Incidence of adverse events

  Throughout study completion, up to 5 years

• Quality of life questionnaire - Core 30 (QLQ-C30)

  At baseline, end of treatment (up to week 12), 4 months, 6 months, 1 year and 2 years

Study Arms (3)

Arm A

NO INTERVENTION

Standard of care : Active surveillance

Arm B

EXPERIMENTAL

Experimental treatment: 4 cycle of Doxorubicine + trabectedin

Drug: Doxorubicin; Drug: Trabectedin

Prospective Cohort

NO INTERVENTION

Standard of care : Active surveillance

Interventions

Doxorubicin DRUG

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

Arm B

Trabectedin DRUG

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

Also known as: Yondelis

Arm B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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)

You may not qualify if:

• 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
• 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.
• Criteria for continuing in the prospective cohort :

Sponsors & Collaborators

• UNICANCER: lead
• PharmaMar: collaborator
• Ligue contre le cancer, France: collaborator
• National Research Agency, France: collaborator
• University Hospital, Marseille: collaborator
• Institut Claudius Regaud: collaborator
• Institut Bergonié: collaborator
• Oncopole: collaborator

Study Sites (25)

Institut de Cancerologie de L'Ouest (Ico)

Angers, 49100, France

NOT YET RECRUITING

Hopital Jean Minjoz

Besançon, 25030, France

NOT YET RECRUITING

Institut Bergonie

Bordeaux, 33076, France

NOT YET RECRUITING

Centre Francois Baclesse

Caen, 14176, France

NOT YET RECRUITING

Centre Jean Perrin

Clermont-Ferrand, 63011, France

NOT YET RECRUITING

Centre Georges Francois Leclerc

Dijon, 21079, France

NOT YET RECRUITING

Chu Limoges

Limoges, 87042, France

NOT YET RECRUITING

Centre Léon Berard

Lyon, 69373, France

NOT YET RECRUITING

Institut Paoli Calmettes

Marseille, 13273, France

NOT YET RECRUITING

La Timone University Hospital

Marseille, 13385, France

RECRUITING

Centre Antoine Lacassagne

Nice, 06189, France

NOT YET RECRUITING

Hopital Saint Louis

Paris, 75010, France

NOT YET RECRUITING

Hôpital Cochin

Paris, 75014, France

NOT YET RECRUITING

Groupe Hospitalier Diaconesses Croix St Simon

Paris, 75020, France

NOT YET RECRUITING

Hopital Tenon

Paris, 75020, France

NOT YET RECRUITING

Institut Curie

Paris, France

NOT YET RECRUITING

Chu de Poitiers

Poitiers, 86000, France

NOT YET RECRUITING

Centre Eugene Marquis

Rennes, 35042, France

NOT YET RECRUITING

Centre Henri Becquerel

Rouen, 76038, France

NOT YET RECRUITING

Institut de cancerologie de l'ouest site Rene Gauducheau

Saint-Herblain, 44805, France

NOT YET RECRUITING

Institut de Cancerologie Strasbourg Europe (Icans)

Strasbourg, France

NOT YET RECRUITING

Institut Claudius Regaud

Toulouse, 31052, France

NOT YET RECRUITING

CHU Bretonneau

Tours, 37000, France

NOT YET RECRUITING

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54519, France

NOT YET RECRUITING

Gustave Roussy

Villejuif, 94800, France

RECRUITING

MeSH Terms

Interventions

Doxorubicin; Trabectedin

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Florence DUFFAUD, MD

  La TIMONE University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amel MEKALICHE, MS

CONTACT

+33 761947045; a-mekaliche@unicancer.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, randomized and comparative phase II trial and prospective cohort

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: January 27, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (25)