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Comparing lymph node mapping techniques for endometrial cancer treatment

A Phase III Trial Of The Impact Of Sentinel Lymph Node Mapping On Patient Reported Lower Extremity Limb Dysfunction In Endometrial Cancer

PHASE3 · NRG Oncology · NCT05646316

This study is testing whether a new way of mapping lymph nodes during surgery for early-stage endometrial cancer can help reduce leg swelling compared to the standard method.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment428 (estimated)
Ages18 Years and up
SexFemale
SponsorNRG Oncology (other)
Drugs / interventionschemotherapy, immunotherapy, radiation
Locations55 sites (Washington D.C., District of Columbia and 54 other locations)
Trial IDNCT05646316 on ClinicalTrials.gov

What this trial studies

This phase III trial evaluates the effectiveness of sentinel lymph node mapping versus standard lymph node dissection in reducing leg swelling (lymphedema) in patients undergoing hysterectomy for stage I endometrial cancer. Participants will be randomized to receive either technique during their surgery, with the primary goal of assessing lower extremity limb dysfunction through patient-reported outcomes. Secondary objectives include measuring changes in limb circumference and validating the sentinel lymph node mapping algorithm's effectiveness. The study aims to provide insights into the long-term impacts of these surgical approaches on patient quality of life.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of stage I endometrial cancer planning to undergo laparoscopic or robotic hysterectomy.

Not a fit: Patients with metastatic disease or those whose concurrent malignancies may interfere with the study's safety or efficacy assessments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical techniques that minimize the risk of lymphedema in patients with endometrial cancer.

How similar studies have performed: Previous studies have shown promise in using sentinel lymph node mapping for various cancers, suggesting potential success for this approach in endometrial cancer.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Histologically proven diagnosis of endometrial cancer based on endometrial sampling with a plan to undergo laparoscopic or robotic hysterectomy and lymphatic assessment as part of primary management. Biopsy must be performed within 90 days prior to registration
* Clinical stage I endometrial cancer based on the following diagnostic workup:

  * History/physical examination within 30 days prior to registration is reassuring for the absence of metastatic disease
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
* Patients must speak English, Spanish, or Korean

Exclusion Criteria:

* Patients whom the surgeon believes is not a candidate for pelvic lymphadenectomy due to medical comorbidities or other technical challenges (i.e. morbid obesity or prior surgery)
* History of chemotherapy or immunotherapy for the treatment of endometrial cancer. Progestin-containing therapies such as megestrol, medroxyprogesterone, or levonorgestrel-containing intrauterine device (IUD) are acceptable
* History of radiation to the pelvis, groin or lower extremities, or surgery to the pelvic lymph nodes or inguinal lymph nodes
* Patients who are going to undergo another elective surgery during the same operative event as their hysterectomy (i.e., sacrocolpopexy, cholecystectomy)
* Patients with severe, active co-morbidity defined as follows:

  * History of patient or provider identified lower extremity lymphedema
  * History of patient or provider identified chronic lower extremity swelling
  * History of lower extremity or pelvic deep venous thromboembolism within 90 days of registration
  * History of lower extremity cellulitis within 90 days of registration

Where this trial is running

Washington D.C., District of Columbia and 54 other locations

+5 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.