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NCT Number: NCT06900582

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

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.

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Key information

Conditions

Lymphadenectomy Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gene, p53 Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Sentinel Lymph Node Biopsy (SLNB) Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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 study is designed as a prospective, multicenter, randomized controlled trial to evaluate the non-inferiority of SLN mapping versus PL+PALND in patients with high-risk EC characterized by p53 mutations. Patients will be stratified based on tumor histology and imaging findings before undergoing surgery. The trial will enroll 374 patients across 22 participating centers.

Key issues addressed include:

  • Oncological Safety: Assessing whether SLN mapping provides equivalent DFS compared to PL+PALND.
  • Survival Outcomes: Evaluating overall survival (OS) and disease-specific survival (DSS) at 36 months.
  • Surgical Morbidity: Comparing perioperative and postoperative complications
  • Quality of Life: Determining patient-reported outcomes related to surgical recovery and long-term functional status.

This study integrates modern molecular classifications, recognizing p53 mutations as a significant prognostic marker. If SLN mapping is proven non-inferior, it could lead to a paradigm shift, reducing the extent of surgical intervention for high-risk EC patients while maintaining oncological safety.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

  • 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

  • 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

Treatment and study plan

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.

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

Primary outcomes

  1. Disease-free-survival (DFS)

    Time frame: 36 months

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

Secondary outcomes

  1. Overall survival (OS)

    Time frame: 36 months

    Time from randomization to death due to endometrial cancer, censored for other deaths/last follow-up.

  2. Disease-specific survival (DSS)

    Time frame: 36 Months

    Time from randomization to death due to endometrial cancer,

  3. Perioperative complications rate and postoperative complications rate

    Time frame: At 30- and 90-days

    The classification of Clavien-Dindo will be used.

  4. Return to intended oncologic treatment (RIOT)

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

    Time in days between the date of surgery and the first day of adjuvant treatment.

  5. Quality of life - EORTC QLQ-C30 questionnaire score

    Time frame: At baseline, 1, 6 and 12 months

    EORTC QLQ-C30 questionnaire is a 30 item instrument meant to assess some of the different aspects that define the quality of life of cancer patients

  6. Quality of life - EORTC QLQ-EN24 questionnaire score

    Time frame: At baseline, 1, 6 and 12 months

    EORTC QLQ-EN24 questionnaire is designed to assess disease and treatment specific aspects of the quality of life of patients with endometrial cancer

  7. Accuracy of PET-CT scan in the detection of metastatic lymph nodes

    Time frame: From Day -60 to Day -1 before surgery (Day 0)

    Determination of the sensitivity, specificity, positive and negative predictive value

  8. Assessment of the rate of unsuccessful SLN mapping, requiring conversion to pelvic lymphadenectomy

    Time frame: At surgery time

    Rate of unsuccessful SLN mapping, requiring conversion to pelvic lymphadenectomy

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: SENTIMETREP53

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Mar 28, 2025
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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