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L-UteCIN: Adjuvant Chemotherapy in High-risk Localized Resected Uterine Leiomyosarcoma
NCT06524583Phase 2
Key facts
- Status
- Recruiting
- Start
- Jan 2025
- Primary completion
- Dec 2029
- Countries
- 1
- Sponsor
- Unicancer
- Modality
- Covalent Small Molecules, Classical Binding Small Molecules, Nucleic Acid-Directed Small Molecules
- Conditions
- uterine leiomyosarcoma (uLMS)
01
Overview
Phase 2, randomised, open-label trial of pegylated liposomal doxorubicin and trabectedin in uterine leiomyosarcoma (uLMS), sponsored by Unicancer. Primary endpoint: Relapse-free survival up to 5 years. Started Jan 2025; status: recruiting.
02
Design
- Study design
- RandomizedOpen-label
03
Who it enrols
Patients with completely resected FIGO stage I uterine leiomyosarcoma, ECOG PS 0-1, adequate organ function, and no prior chemotherapy for sarcoma. High-risk CINSARC signature patients are randomized; low-risk patients enter a prospective cohort.
04
Endpoints
Primary
Relapse-free survival
Secondary
Overall survival
Metastases-free survival
Incidence of adverse events
Quality of life questionnaire - Core 30
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