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NCT06900582Not yet recruiting

SENTInel Node Mapping Versus Comprehensive Lymphadenectomy in p53-Mutated Endometrial Cancer: A Non-Inferiority Randomized Trial

Comparing SENTInel Node Mapping to Comprehensive Lymphadenectomy in p53-Mutated EndoMETRial Cancer: a Prospective, Open-label, Controlled, Randomized, Non-inferiority, De-escalation Trial

Source: ClinicalTrials.gov · Last updated 17 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
374 (estimated)
First submitted
10 Mar 2025
Start date
Jun 2026
Primary completion date
Oct 2031
Lead sponsor
University Hospital, Strasbourg, France
NCT number
NCT06900582

What you commit to

  • Study type: Interventional
  • Planned participants: 374
  • From Jun 2026 to the primary completion date, Oct 2031
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous chemo-, radio, or endocrine therapy for EC
  • Any contra-indication to lymphadenectomy and/or chemotherapy

Other illness

  • 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

Other

  • Recurrent EC
  • Any contraindication to laparoscopy
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

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This page is information, not medical advice. Discuss any trial with your doctor.