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

Description

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.

Conditions

Stage I Uterine Corpus Cancer AJCC v8

Study Overview

Study Details

Study overview

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.

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

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

Condition
Stage I Uterine Corpus Cancer AJCC v8
Intervention / Treatment

-

Contacts and Locations

Washington

George Washington University Medical Center, Washington, District of Columbia, United States, 20037

Coral Gables

UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables, Florida, United States, 33146

Deerfield Beach

UM Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach, Florida, United States, 33442

Miami

University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States, 33136

Plantation

UM Sylvester Comprehensive Cancer Center at Plantation, Plantation, Florida, United States, 33324

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

Warrenville

Northwestern Medicine Cancer Center Warrenville, Warrenville, Illinois, United States, 60555

Carmel

IU Health North Hospital, Carmel, Indiana, United States, 46032

Indianapolis

Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States, 46202

Marrero

West Jefferson Medical Center, Marrero, Louisiana, United States, 70072

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 or Spanish
  • * 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
  • * For the bioimpedance sub study only: patients with implantable metal devices (i.e. defibrillator, metal joint replacements, etc.) will not be eligible to participate in the bioimpedance sub study but will be eligible to participate in the overall study

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

NRG Oncology,

Edward J Tanner, PRINCIPAL_INVESTIGATOR, NRG Oncology

Study Record Dates

2026-10-31