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NCT05646316RecruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 7 Aug 2026

Brief summary (registry, in English)

This phase III trial compares the effect of sentinel lymph node mapping to standard lymph node dissection in reducing the risk of swelling in the legs (lymphedema) in patients undergoing a hysterectomy for stage I endometrial cancer. Standard lymph node dissection removes lymph nodes around the uterus during a hysterectomy to look for spread of cancer from the uterus to nearby lymph nodes. Sentinel lymph node mapping uses a special dye and camera to look for cancer that may have spread to nearby lymph nodes. Comparing the results of the procedures may help doctors predict the risk of long-term swelling in the legs.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
428 (estimated)
First submitted
2 Dec 2022
Start date
7 Dec 2022
Primary completion date
31 Oct 2026
Lead sponsor
NRG Oncology
NCT number
NCT05646316

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 428
  • From 7 Dec 2022 to the primary completion date, 31 Oct 2026
  • 60 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)
  • Patients who are going to undergo another elective surgery during the same operative event as their hysterectomy (i.e., sacrocolpopexy, cholecystectomy)

Other illness

  • 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 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (60)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Gachon University Gil Hospital
Coordinator of this site? Confirm its status
IncheonSouth KoreaRecruiting
Asan Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Ewha Woman's University Mokdong Hospital
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SeoulSouth KoreaRecruiting
Samsung Changwon Hospital
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SeoulSouth KoreaSuspended
Gangnam Severance Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Augusta University Medical Center
Coordinator of this site? Confirm its status
AugustaUnited StatesRecruiting
University of Maryland/Greenebaum Cancer Center
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BaltimoreUnited StatesRecruiting
UM Upper Chesapeake Medical Center
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Bel AirUnited StatesRecruiting
Intermountain Health West End Clinic
Coordinator of this site? Confirm its status
BillingsUnited StatesActive, not recruiting
Saint Vincent Frontier Cancer Center
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BillingsUnited StatesActive, not recruiting
Saint Vincent Healthcare
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BillingsUnited StatesActive, not recruiting
Bryn Mawr Hospital
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Bryn MawrUnited StatesSuspended
Saint James Community Hospital and Cancer Treatment Center
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ButteUnited StatesActive, not recruiting
IU Health North Hospital
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CarmelUnited StatesRecruiting
University of Virginia Cancer Center
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CharlottesvilleUnited StatesRecruiting
Northwestern University
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ChicagoUnited StatesRecruiting
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coordinator of this site? Confirm its status
Coral GablesUnited StatesRecruiting
UT Southwestern/Simmons Cancer Center-Dallas
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DallasUnited StatesRecruiting
Parkland Memorial Hospital
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DallasUnited StatesRecruiting
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
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Deerfield BeachUnited StatesRecruiting
Wayne State University/Karmanos Cancer Institute
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DetroitUnited StatesRecruiting
UM Sylvester Comprehensive Cancer Center at Doral
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DoralUnited StatesRecruiting
Fairview Southdale Hospital
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EdinaUnited StatesRecruiting
Weisberg Cancer Treatment Center
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Farmington HillsUnited StatesRecruiting
McLaren Cancer Institute-Flint
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FlintUnited StatesRecruiting
UT Southwestern/Simmons Cancer Center-Fort Worth
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Fort WorthUnited StatesRecruiting
Memorial Hermann Texas Medical Center
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HoustonUnited StatesRecruiting
Houston Methodist Hospital
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HoustonUnited StatesActive, not recruiting
Methodist Willowbrook Hospital
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HoustonUnited StatesActive, not recruiting
Houston Methodist West Hospital
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HoustonUnited StatesActive, not recruiting
Indiana University/Melvin and Bren Simon Cancer Center
Coordinator of this site? Confirm its status
IndianapolisUnited StatesRecruiting
Fred and Pamela Buffett Cancer Center - Kearney
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KearneyUnited StatesRecruiting
Women's Cancer Center of Nevada
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Las VegasUnited StatesRecruiting
Fairview Clinics and Surgery Center Maple Grove
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Maple GroveUnited StatesRecruiting
Saint John's Hospital - Healtheast
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MaplewoodUnited StatesRecruiting
West Jefferson Medical Center
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MarreroUnited StatesRecruiting
East Jefferson General Hospital
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MetairieUnited StatesRecruiting
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Coordinator of this site? Confirm its status
MetairieUnited StatesRecruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center
Coordinator of this site? Confirm its status
MiamiUnited StatesRecruiting
UM Sylvester Comprehensive Cancer Center at Kendall
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MiamiUnited StatesRecruiting
University Medical Center New Orleans
Coordinator of this site? Confirm its status
New OrleansUnited StatesRecruiting
Louisiana State University Health Science Center
Coordinator of this site? Confirm its status
New OrleansUnited StatesRecruiting
University of Miami Sylvester Comprehensive Cancer Center at Sole Mia
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North MiamiUnited StatesRecruiting
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesRecruiting
Nebraska Medicine-Village Pointe
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OmahaUnited StatesRecruiting
Alegent Health Bergan Mercy Medical Center
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OmahaUnited StatesActive, not recruiting
University of Nebraska Medical Center
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OmahaUnited StatesRecruiting
Paoli Memorial Hospital
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PaoliUnited StatesSuspended
UM Sylvester Comprehensive Cancer Center at Plantation
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PlantationUnited StatesRecruiting
Fairview Northland Medical Center
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PrincetonUnited StatesRecruiting
Women and Infants Hospital
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ProvidenceUnited StatesRecruiting
UT Southwestern Clinical Center at Richardson/Plano
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RichardsonUnited StatesRecruiting
Regions Hospital
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Saint PaulUnited StatesRecruiting
Mercy Hospital Springfield
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SpringfieldUnited StatesRecruiting
Houston Methodist Sugar Land Hospital
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Sugar LandUnited StatesActive, not recruiting
Houston Methodist The Woodlands Hospital
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The WoodlandsUnited StatesActive, not recruiting
Northwestern Medicine Cancer Center Warrenville
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WarrenvilleUnited StatesRecruiting
George Washington University Medical Center
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Washington D.C.United StatesSuspended
Lankenau Medical Center
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WynnewoodUnited StatesSuspended
Fairview Lakes Medical Center
Coordinator of this site? Confirm its status
WyomingUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.