SENTInel Node Mapping Versus Comprehensive Lymphadenectomy in P53-Mutated Endometrial Cancer: a Non-Inferiority Randomized Trial

Launched by UNIVERSITY HOSPITAL, STRASBOURG, FRANCE · Mar 21, 2025

Keywords

ClinConnect Summary

The necessity of extensive lymph node dissection in endometrial cancer remains a subject of debate. Although systematic pelvic and para-aortic lymphadenectomy (PL+PALND) improves disease staging and influences adjuvant therapy, its impact on survival in high-risk endometrial cancer (EC) is still controversial. Recent evidence suggests that SLN mapping may provide comparable staging accuracy while reducing surgical complications. However, the oncological safety of replacing PL+PALND with SLN mapping in high-risk EC patients, particularly those with p53 mutations, remains uncertain.

This stu...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1 . ≥ 18 years old 2. High-risk endometrial cancer, as defined by the ESGO-ESTRO 20211 histological and molecular classification, with p53 mutation confirmed on endometrial biopsy or curettage in the two months before the surgery 3. Magnetic Resonance Imaging (MRI) confirmed FIGO 2023 stage I and II endometrial cancer, i.e., confined to the uterine corpus, ovary and the cervical stroma.
• • 4. Participant with a scheduled surgical intervention (total hysterectomy and bilateral salpingo-oophorectomy, with omentectomy in the case of serous, carcinosarcoma and undifferenciated type EC) 5. Eligible for comprehensive lymphadenectomy by laparoscopy 6. Participant with a negative Positron Emission Tomography scan (PET-CT scan) for lymph node involvement in the two months before the intervention 7. ECOG (Eastern Cooperative Oncology Group) performance status of 0-1 8. Participant able to provide written informed consent
• Exclusion Criteria:
• • 1. Recurrent EC
• • 2. Previous chemo-, radio, or endocrine therapy for EC
• • 3. Any contra-indication to lymphadenectomy and/or chemotherapy
• • 4. Any contraindication to laparoscopy
• • 5. Any criteria, based on the investigator's judgment, that would contraindicate the surgical procedure (e.g., but not limited to, anesthetic risk, bleeding, significant comorbidities)
• • 6. Any known disorder or circumstances making participation in trial and follow-up questionable
• • 7. Patients with other malignancies for whom the disease(s) and/or associated treatment(s) might have an impact on the patient's cancer prognosis
• • 8. Known HIV-infection or AIDS
• • 9. Simultaneous participation in another interventional clinical trial
• • 10. Within the exclusion period following participation in another interventional clinical trial
• • 11. Patients with difficulties in reading or understanding French, or an inability to understand the delivered information
• • 12. Patients in emergency medical situations
• • 13. Patient under guardianship or limited guardianship