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
NCT Number: NCT06524583
Acronym: L-UteCIN
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Leiomyosarcoma Uterus
Interventions: DRUG: Doxorubicin|DRUG: Trabectedin
Sponsor: UNICANCER
Collaborators: PharmaMar|Ligue contre le cancer, France|National Research Agency, France|University Hospital, Marseille|Institut Claudius Regaud|Institut Bergonié|Oncopole
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 198
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-10
Completion Date: 2030-12
Locations: Institut de Cancerologie de L'Ouest (Ico), Angers, 49100, France|Hopital Jean Minjoz, Besancon, 25030, France|Institut Bergonie, Bordeaux, 33076, France|Centre Francois Baclesse, Caen, 14176, France|Centre Jean Perrin, Clermont-Ferrand, 63011, France|Centre Georges Francois Leclerc, Dijon, 21079, France|Chu Limoges, Limoges, 87042, France|Centre Léon Berard, Lyon, 69373, France|Institut Paoli Calmettes, Marseille, 13273, France|La Timone University Hospital, Marseille, 13385, France|Centre Antoine Lacassagne, Nice, 06189, France|Hopital Saint Louis, Paris, 75010, France|Hôpital Cochin, Paris, 75014, France|Groupe Hospitalier Diaconesses Croix St Simon, Paris, 75020, France|Hopital Tenon, Paris, 75020, France|Institut Curie, Paris, France|Chu de Poitiers, Poitiers, 86000, France|Centre Eugene Marquis, Rennes, 35042, France|Centre Henri Becquerel, Rouen, 76038, France|Institut de cancerologie de l'ouest site Rene Gauducheau, Saint Herblain, 44805, France|Institut de Cancerologie Strasbourg Europe (Icans), Strasbourg, France|Institut Claudius Regaud, Toulouse, 31052, France|CHU Bretonneau, Tours, 37000, France|Centre Alexis Vautrin, Vandoeuvre-les-nancy, 54519, France|Gustave Roussy, Villejuif, 94800, France

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.

Primary Outcome Measures: 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., From randomization or enrollment to disease recurrence or death, up to 5 years
Secondary Outcome Measures: 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., 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., 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., 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., At baseline, end of treatment (up to week 12), 4 months, 6 months, 1 year and 2 years