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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 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2025-03-30

No results posted yet for this study

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

Interventions

DRUG

Doxorubicin

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

DRUG

Trabectedin

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

Sponsors & Collaborators

  • PharmaMar

    collaborator INDUSTRY

  • Ligue contre le cancer, France

    collaborator OTHER

  • National Research Agency, France

    collaborator OTHER

  • University Hospital, Marseille

    collaborator OTHER

  • Institut Claudius Regaud

    collaborator OTHER

  • Institut Bergonié

    collaborator OTHER

  • Oncopole

    collaborator UNKNOWN

  • UNICANCER

    lead OTHER

Principal Investigators

  • Florence DUFFAUD, MD · La TIMONE University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-27
Primary Completion
2029-12-31
Completion
2030-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06524583 on ClinicalTrials.gov