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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Strasbourg, France

About this 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.

Eligibility criteria

Qualifiers

None

Disqualifiers

Recurrent EC

Previous chemo-, radio, or endocrine therapy for EC

Any contra-indication to lymphadenectomy and/or chemotherapy

Any contraindication to laparoscopy

Trial design

Treatments tested in this trial

  • Sentinel Lymph Node Mapping
  • Comprehensive pelvic and para-aortic lymphadenectomy

Treatment groups

374 Participants
are divided into 2 treatment groups

Locations

This trial has no locations