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

NCT06900582 | Not Yet Recruiting

• 1 other identifier: 9423
• Study Type: interventional
• Target: 374
• Locations: 0 countries
• Sites: N/A

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 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

Lymphadenectomy; Endometrial Cancer; Gene, p53; Sentinel Lymph Node Biopsy (SLNB)

Keywords

Endometrial cancer; Sentinel lymph node biopsy; Lymphadenectomy; p53 mutation

Outcome Measures

Primary Outcomes (1)

• Disease-free-survival (DFS)

  Time from randomization to first recurrence or death from any cause, censored at last follow-up

  36 months

Secondary Outcomes (8)

• Overall survival (OS)

  36 months

• Disease-specific survival (DSS)

  36 Months

• Perioperative complications rate and postoperative complications rate

  At 30- and 90-days

• Return to intended oncologic treatment (RIOT)

  From the date of surgery (Day 0) until the first day of adjuvant treatment, assessed up to 90 days.

• Quality of life - EORTC QLQ-C30 questionnaire score

  At baseline, 1, 6 and 12 months

Study Arms (2)

Sentinel Lymph Node Mapping

EXPERIMENTAL

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.

Procedure: Sentinel Lymph Node Mapping

Complete lymphadenectomy

ACTIVE COMPARATOR

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.

Procedure: Comprehensive pelvic and para-aortic lymphadenectomy

Interventions

Sentinel Lymph Node Mapping PROCEDURE

The SLN mapping protocol will follow the EU guidelines and the consensus in competency assessment tool. Prior to SLN mapping, a full inspection of the pelvic areas with white light is performed to exclude the presence of extrauterine disease. The next surgical steps will be 1- identification of external iliac vessels, 2- identification of internal iliac artery, 3- dissection of the ureter, 4- development of paravesical space and 5- identification of obliterated umbilical ligament. The dissection technique must avoid disrupting lymphatic channels and isolate nodal tissue from the local anatomy. Indocyanine green (1.25mg/mL) will be injected in the cervix at the 3 and 9 o'clock positions, with 1mL superficial and 1mL deep, for a total of 4mL. All mapped SLNs must be completely excised, and any visually suspicious nodes should also be removed, regardless of the mapping results. If the SLN mapping appears to be unfeasible, a side-specific pelvic lymphadenectomy will be performed.

Sentinel Lymph Node Mapping

Comprehensive pelvic and para-aortic lymphadenectomy PROCEDURE

The resection of at least one lymph node in each of the 12 retroperitoneal regions is necessary: A: upper para-aortic region B: lower para-aortic region C: interaorto-caval region D: paracaval region E: right and left iliaca communis region F: right and left iliaca externa region G: right and left fossa obturatoria region: defined by external and internal arteria iliaca, pelvic sidewall H: right and left iliaca interna region: lymph nodes adjacent to or medial of the internal iliacal artery

Complete lymphadenectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.
• \. 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Related Publications (1)

• Akladios 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 DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 28, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2031
• Study Completion (Estimated): October 1, 2031
• Last Updated: February 17, 2026

Record last verified: 2026-02