RecruitingPhase 2NCT06524583

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

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


Sponsor

UNICANCER

Enrollment

198 participants

Start Date

Jan 27, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether chemotherapy given after surgery can reduce the chance of uterine leiomyosarcoma returning in patients identified as "high-risk" by a special biological tumor test. Uterine leiomyosarcoma is a rare and aggressive type of uterine cancer, and identifying who is most likely to benefit from additional treatment is a key challenge. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with uterine leiomyosarcoma confirmed by a specialist pathologist - Your surgery (total hysterectomy) was performed within the past 8 weeks and removed all visible cancer (stage I, complete resection) - You have not had chemotherapy before for this cancer - Your tumor tissue is available for a specialized biological risk test (CINSARC NanoCind®) - Your heart, blood, liver, and kidney function meet the required thresholds **You may NOT be eligible if...** - You have another type of uterine sarcoma (e.g., adenosarcoma or endometrial sarcoma) - You have evidence of remaining or measurable disease after surgery - You have had another cancer in the past 5 years (some treated cancers may be acceptable) - You have planned pelvic radiation after surgery - You have heart problems, active hepatitis B or C, or HIV - You are breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDoxorubicin

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

DRUGTrabectedin

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


Locations(25)

Institut de Cancerologie de L'Ouest (Ico)

Angers, France

Hopital Jean Minjoz

Besançon, France

Institut Bergonie

Bordeaux, France

Centre Francois Baclesse

Caen, France

Centre Jean Perrin

Clermont-Ferrand, France

Centre Georges Francois Leclerc

Dijon, France

Chu Limoges

Limoges, France

Centre Léon Berard

Lyon, France

Institut Paoli Calmettes

Marseille, France

La Timone University Hospital

Marseille, France

Centre Antoine Lacassagne

Nice, France

Hopital Saint Louis

Paris, France

Hôpital Cochin

Paris, France

Groupe Hospitalier Diaconesses Croix St Simon

Paris, France

Hopital Tenon

Paris, France

Institut Curie

Paris, France

Chu de Poitiers

Poitiers, France

Centre Eugene Marquis

Rennes, France

Centre Henri Becquerel

Rouen, France

Institut de cancerologie de l'ouest site Rene Gauducheau

Saint-Herblain, France

Institut de Cancerologie Strasbourg Europe (Icans)

Strasbourg, France

Institut Claudius Regaud

Toulouse, France

CHU Bretonneau

Tours, France

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, France

Gustave Roussy

Villejuif, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06524583