Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Gene, p53 | — | UNRESOLVED | — |
| Lymphadenectomy | — | UNRESOLVED | — |
| Sentinel Lymph Node Biopsy (SLNB) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comprehensive pelvic and para-aortic lymphadenectomy | Procedure | — | UNRESOLVED |
| Sentinel Lymph Node Mapping | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sentinel Lymph Node Mapping
- description
- Patients in this arm will undergo sentinel lymph node (SLN) mapping, followed by total hysterectomy, bilateral salpingo-oophorectomy, and, for serous, carcinosarcoma and undifferentiated type EC, infracolic omentectomy. The determination to perform para-aortic lymphadenectomy on SLN+ patients is left to the clinical team. Adjuvant treatment will depend of the status.
- interventionNames
- Procedure: Sentinel Lymph Node Mapping
- type
- ACTIVE_COMPARATOR
- label
- Complete lymphadenectomy
- description
- Patients in this arm will undergo comprehensive pelvic and para-aortic lymphadenectomy that extends up to the left renal vein, followed by total hysterectomy and bilateral salpingo-oophorectomy, with omentectomy for serous, carcinosarcoma and undifferentiated type EC. Adjuvant treatment will depend of the status.
- interventionNames
- Procedure: Comprehensive pelvic and para-aortic lymphadenectomy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDAkladios C, Lecointre L, Lefebvre F, Eberst L, Menoux I, Ouldamer L, Lavoue V, Huchon C, Dabi Y, Gertych W, Guyon F, Laas E, Bonneau C, Kerbage Y, Chauleur C, Fauvet R, Brun JL, Raimond E, Gauthier T, Costaz H, Rouzier R, Hotton J, Marchal F, Loaec C, Ramanah R, Chopin N, Querleu D, Jochum F. Comparison of sentinel lymph node mapping with comprehensive lymphadenectomy in p53-mutated endometrial cancer: a prospective, multi-center, non-inferiority, open-label, de-escalation, randomized, controlled trial (Study Protocol - SENTIMETREP53). Int J Gynecol Cancer. 2026 Feb 6:104547. doi: 10.1016/j.ijgc.2026.104547. Online ahead of print. PMID 41796475