RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2022-12-07

Study Completion:2026-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05646316

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Edward J Tanner

PRINCIPAL_INVESTIGATOR

NRG Oncology

Study Locations (Sites)

George Washington University Medical Center

Washington, District of Columbia, 20037

United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146

United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442

United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136

United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, 33324

United States

Northwestern University

Chicago, Illinois, 60611

United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555

United States

IU Health North Hospital

Carmel, Indiana, 46032

United States

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202

United States

West Jefferson Medical Center

Marrero, Louisiana, 70072

United States

East Jefferson General Hospital

Metairie, Louisiana, 70006

United States

Louisiana State University Health Science Center

New Orleans, Louisiana, 70112

United States

University Medical Center New Orleans

New Orleans, Louisiana, 70112

United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201

United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201

United States

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 48334

United States

McLaren Cancer Institute-Flint

Flint, Michigan, 48532

United States

Fairview Southdale Hospital

Edina, Minnesota, 55435

United States

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, 55369

United States

Saint John's Hospital - Healtheast

Maplewood, Minnesota, 55109

United States

Fairview Northland Medical Center

Princeton, Minnesota, 55371

United States

Regions Hospital

Saint Paul, Minnesota, 55101

United States

Fairview Lakes Medical Center

Wyoming, Minnesota, 55092

United States

Mercy Hospital Springfield

Springfield, Missouri, 65804

United States

Alegent Health Bergan Mercy Medical Center

Omaha, Nebraska, 68124

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

Women's Cancer Center of Nevada

Las Vegas, Nevada, 89106

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010

United States

Paoli Memorial Hospital

Paoli, Pennsylvania, 19301

United States

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096

United States

Women and Infants Hospital

Providence, Rhode Island, 02905

United States

Parkland Memorial Hospital

Dallas, Texas, 75235

United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390

United States

Houston Methodist Hospital

Houston, Texas, 77030

United States

Methodist Willowbrook Hospital

Houston, Texas, 77070

United States

Houston Methodist West Hospital

Houston, Texas, 77094

United States

UT Southwestern Clinical Center at Richardson/Plano

Richardson, Texas, 75080

United States

Houston Methodist Sugar Land Hospital

Sugar Land, Texas, 77479

United States

Houston Methodist The Woodlands Hospital

The Woodlands, Texas, 77385

United States

University of Virginia Cancer Center

Charlottesville, Virginia, 22908

United States

Collaborators and Investigators

Sponsor: NRG Oncology

Edward J Tanner, PRINCIPAL_INVESTIGATOR, NRG Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-07

Study Completion Date2026-10-31

Study Record Updates

Study Start Date2022-12-07

Study Completion Date2026-10-31

Terms related to this study

Additional Relevant MeSH Terms

Stage I Uterine Corpus Cancer AJCC v8