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
Trial Information
Current as of April 23, 2025
Not yet recruiting
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
About University Hospital, Strasbourg, France
The University Hospital of Strasbourg, France, is a leading academic medical center renowned for its commitment to advancing healthcare through innovative clinical research and patient-centered care. As a prominent sponsor of clinical trials, the institution collaborates with a diverse range of healthcare professionals and research teams to explore cutting-edge therapies and treatment modalities. With state-of-the-art facilities and a multidisciplinary approach, the University Hospital of Strasbourg plays a pivotal role in translating scientific discoveries into effective clinical applications, contributing significantly to the advancement of medical knowledge and improved patient outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported