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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.
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
Age
18 - 75 years
Sex
FEMALE
Healthy Volunteers
No
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
Start Date
January 27, 2025
Primary Completion Date
December 1, 2029
Completion Date
December 1, 2030
Last Updated
March 30, 2025
198
ESTIMATED participants
Doxorubicin
DRUG
Trabectedin
DRUG
Lead Sponsor
UNICANCER
Collaborators
Data Source & Attribution
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