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