SENTInel Node Mapping Versus Comprehensive Lymphadenectomy in p53-Mutated Endometrial Cancer: A Non-Inferiority Randomized Trial

This study evaluates surgical strategies for treating patients with FIGO 2023 stage I and II high-risk endometrial cancer (EC) exhibiting p53 mutations. The trial aims to assess whether a less invasive sentinel lymph node (SLN) mapping approach provides non-inferior oncological outcomes compared to the current standard of systematic pelvic and para-aortic lymphadenectomy (PL+PALND). By minimizing surgical morbidity, this study seeks to determine if SLN mapping can safely replace comprehensive lymphadenectomy without compromising disease-free survival (DFS). Eligible patients will be randomized to undergo either sentinel lymph node mapping or complete lymphadenectomy, followed by standard hysterectomy and bilateral salpingo-oophorectomy. The primary outcome is DFS at 36 months, with secondary outcomes including overall survival, disease-specific survival, perioperative complications, and quality of life.

NCT Number	NCT06900582
Lead Sponsor	University Hospital, Strasbourg, France
Conditions	Lymphadenectomy, Endometrial Cancer, Gene, p53, Sentinel Lymph Node Biopsy (SLNB)
Enrollment	374 participants
Start Date	2026-06
Primary Completion	2031-10 (estimated)
Study Completion	2031-10 (estimated)
Updated on ClinicalTrials.gov	2026-02-17