Status:
NOT_YET_RECRUITING
SENTInel Node Mapping Versus Comprehensive Lymphadenectomy in P53-Mutated Endometrial Cancer: a Non-Inferiority Randomized Trial
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Lymphadenectomy
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 invasiv...
Detailed Description
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 i...
Eligibility Criteria
Inclusion
- 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
- Recurrent EC
- Previous chemo-, radio, or endocrine therapy for EC
- Any contra-indication to lymphadenectomy and/or chemotherapy
- Any contraindication to laparoscopy
- 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)
- Any known disorder or circumstances making participation in trial and follow-up questionable
- Patients with other malignancies for whom the disease(s) and/or associated treatment(s) might have an impact on the patient's cancer prognosis
- Known HIV-infection or AIDS
- Simultaneous participation in another interventional clinical trial
- Within the exclusion period following participation in another interventional clinical trial
- Patients with difficulties in reading or understanding French, or an inability to understand the delivered information
- Patients in emergency medical situations
- Patient under guardianship or limited guardianship
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2031
Estimated Enrollment :
374 Patients enrolled
Trial Details
Trial ID
NCT06900582
Start Date
October 1 2025
End Date
October 1 2031
Last Update
March 28 2025
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