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

RecruitingPhase 3

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

Who can join

Ages 18 and older · Women

Full eligibility 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

About the study

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.

What is being tested

Sponsor: NRG Oncology · Participants: 428 · Started: Dec 7, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05646316

Locations in the U.S.

FloridaUM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables
UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Doral, Doral
UM Sylvester Comprehensive Cancer Center at Kendall, Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami
University of Miami Sylvester Comprehensive Cancer Center at Sole Mia, North Miami
UM Sylvester Comprehensive Cancer Center at Plantation, Plantation
GeorgiaAugusta University Medical Center, Augusta
IllinoisNorthwestern University, Chicago
Northwestern Medicine Cancer Center Warrenville, Warrenville
IndianaIU Health North Hospital, Carmel
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis
LouisianaWest Jefferson Medical Center, Marrero
East Jefferson General Hospital, Metairie
LSU Healthcare Network / Metairie Multi-Specialty Clinic, Metairie
Louisiana State University Health Science Center, New Orleans
University Medical Center New Orleans, New Orleans
MarylandUniversity of Maryland/Greenebaum Cancer Center, Baltimore
UM Upper Chesapeake Medical Center, Bel Air
MichiganWayne State University/Karmanos Cancer Institute, Detroit
Weisberg Cancer Treatment Center, Farmington Hills
McLaren Cancer Institute-Flint, Flint
MinnesotaFairview Southdale Hospital, Edina
Fairview Clinics and Surgery Center Maple Grove, Maple Grove
Saint John's Hospital - Healtheast, Maplewood
Fairview Northland Medical Center, Princeton
Regions Hospital, Saint Paul
Fairview Lakes Medical Center, Wyoming
MissouriMercy Hospital Springfield, Springfield
NebraskaFred and Pamela Buffett Cancer Center - Kearney, Kearney
Nebraska Medicine-Village Pointe, Omaha
University of Nebraska Medical Center, Omaha
NevadaWomen's Cancer Center of Nevada, Las Vegas
OklahomaUniversity of Oklahoma Health Sciences Center, Oklahoma City
Rhode IslandWomen and Infants Hospital, Providence
TexasParkland Memorial Hospital, Dallas
UT Southwestern/Simmons Cancer Center-Dallas, Dallas
UT Southwestern/Simmons Cancer Center-Fort Worth, Fort Worth
Memorial Hermann Texas Medical Center, Houston
UT Southwestern Clinical Center at Richardson/Plano, Richardson
VirginiaUniversity of Virginia Cancer Center, Charlottesville

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.