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Sentinel Lymph Node Mapping for Stage I Endometrial Cancer

This study is comparing two ways to check for cancer spread in people with Stage I endometrial cancer (cancer of the uterus lining). You would have a hysterectomy (surgery to remove the uterus) and then either sentinel lymph node mapping or standard lymph node dissection. Sentinel lymph node mapping uses a special dye called Indocyanine Green Solution and a camera to find lymph nodes that might have cancer. Standard lymph node dissection removes lymph nodes around the uterus. Researchers want to see if sentinel lymph node mapping can reduce the risk of swelling in the legs (lymphedema) compared to the standard approach. They will measure how often people report lower extremity limb dysfunction (problems with leg function) for up to 39 months after surgery. This study aims to enroll 428 women aged 18 and older with a confirmed diagnosis of Stage I endometrial cancer.

Study design
This is an interventional study comparing two different surgical approaches for assessing lymph nodes. It plans to enroll 428 participants.
What's involved
You would undergo blood sample collection, imaging, a minimally invasive hysterectomy, and a sentinel lymph node excision using Indocyanine Green Solution.
Compensation
Not stated in the trial record.
Follow-up
Your lower extremity limb dysfunction will be measured from 18 months to 39 months after your hysterectomy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05646316

Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer

Recruiting
PHASE3Ages 18+InterventionalSupportive care
NRG Oncology
~428 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:Biospecimen CollectionDiagnostic Imaging TestingExcisional BiopsyIndocyanine Green SolutionMinimally Invasive SurgeryPelvic Lymphadenectomy

At a glance

Recruiting sites
45 of 60 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of patient-reported lower extremity limb dysfunction
Measured over From 18 months post-hysterectomy after undergoing lymphatic assessment to 39 months

Conditions

Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8

Explore related trials

CarcinosarcomaEndometrial Carcinoma

Where it's being run

60 sites across 20 states
Texas10
Florida7
Minnesota6
Louisiana5
Montana4
Nebraska4
South Korea4
Michigan3

Study leadership

  • Edward J Tanner · PRINCIPAL_INVESTIGATOR · NRG Oncology

Who to contact

Site Public Contact
305-243-2647
Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence of patient-reported lower extremity limb dysfunctionFrom 18 months post-hysterectomy after undergoing lymphatic assessment to 39 months

    The primary endpoint is the incidence of patient-reported lower extremity limb dysfunction at 18 months post-hysterectomy after undergoing lymphatic assessment according to a National Comprehensive Cancer Network guideline-based sentinel lymph node (SLN) mapping algorithm with or without completion of lymphadenectomy. The primary endpoint will be assessed using the Gynecologic Cancer Lymphedema Questionnaire (GCLQ) questionnaire. Surveys will be performed at enrollment (pre-surgery) and at 3, 6, 9, 12, and 18 months post-surgery. Patient-reported lower extremity limb dysfunction will be defined as an increase in GCLQ symptom score of at least four (4) points from baseline at any time during the 18 months follow-up. The primary null hypothesis will be evaluated with an intent-to-treat chi-squared test, adjusted for stratification factors. Proportional hazards modeling will be used to generate a hazard ratio and 95% confidence limits of Arm 1 versus Arm 2.