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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
198
60 mg/m² intravenous (IV) at Day 1 every 3 weeks (4 cycles)
1.1 mg/m² intravenous (IV) at Day 1 every 3 weeks (4 cycles)
Institut de Cancerologie de L'Ouest (Ico)
Angers, France
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.
Time frame: From randomization or enrollment to disease recurrence or death, up to 5 years
Overall survival
The overall survival is the length of time from randomization (or enrollment for patients in the prospective cohort) that patients enrolled in the study are still alive.
Time frame: From randomization or enrollment to death, up to 5 years
Metastases-free survival
The metastases-free survival is the length of time during and after the treatment for cancer that a patient is still alive and the cancer has not spread to other parts of the body.
Time frame: From randomization or enrollment to metastases onset or death, up to 5 years
Incidence of adverse events
The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders. Safety and tolerability (NCI-CTCAE v5.0) will be assessed through the incidence of adverse events, treatment-related adverse events, serious adverse events (SAEs); and death.
Time frame: Throughout study completion, up to 5 years
Quality of life questionnaire - Core 30 (QLQ-C30)
Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
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Hopital Jean Minjoz
Besançon, France
NOT_YET_RECRUITINGInstitut Bergonie
Bordeaux, France
NOT_YET_RECRUITINGCentre Francois Baclesse
Caen, France
NOT_YET_RECRUITINGCentre Jean Perrin
Clermont-Ferrand, France
NOT_YET_RECRUITINGCentre Georges Francois Leclerc
Dijon, France
NOT_YET_RECRUITINGChu Limoges
Limoges, France
NOT_YET_RECRUITINGCentre Léon Berard
Lyon, France
NOT_YET_RECRUITINGInstitut Paoli Calmettes
Marseille, France
NOT_YET_RECRUITINGLa Timone University Hospital
Marseille, France
RECRUITING...and 15 more locations
Time frame: At baseline, end of treatment (up to week 12), 4 months, 6 months, 1 year and 2 years