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

This clinical trial is studying two different surgical methods for treating women with high-risk endometrial cancer that has a specific genetic mutation called p53. The main goal is to see if a less invasive approach called sentinel lymph node mapping (SLN mapping) can provide similar cancer control compared to the standard method, which involves a more extensive surgery known as comprehensive lymphadenectomy. By using SLN mapping, the hope is to reduce complications and recovery time while still effectively managing the cancer. Participants will be randomly assigned to one of the two surgical methods, followed by a standard procedure to remove the uterus and ovaries.

To be eligible for this trial, women must be at least 18 years old and diagnosed with high-risk endometrial cancer at specific early stages. They should have a confirmed p53 mutation and not have had previous treatments like chemotherapy or radiation. Participants will need to provide informed consent and will be monitored over 36 months to track their recovery, any complications, and overall quality of life. This study aims to find a safer, effective alternative to the traditional surgery, which could benefit many women facing this type of cancer.

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