RecruitingPhase 3NCT05646316

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

Sponsor

NRG Oncology

Enrollment

428 participants

Start Date

Dec 7, 2022

Study Type

INTERVENTIONAL

Conditions

Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether a less invasive technique called sentinel lymph node mapping — which checks only a few key lymph nodes instead of removing many — leads to less leg swelling and better quality of life after surgery for early-stage uterine cancer. **You may be eligible if...** - You have been diagnosed with Stage I endometrial (uterine) cancer - You are planning to have a laparoscopic or robotic hysterectomy - You are 18 or older and in generally good health - You speak English or Spanish **You may NOT be eligible if...** - You have had prior chemotherapy, radiation to the pelvis, or surgery on pelvic lymph nodes - Your surgeon believes lymph node surgery is too risky for you (e.g., due to severe obesity or prior surgeries) - You plan to have additional elective surgery at the same time as your hysterectomy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREDiagnostic Imaging Testing

Undergo imaging

PROCEDUREExcisional Biopsy

Undergo sentinel lymph node excision

DRUGIndocyanine Green Solution

Given via injection

PROCEDUREMinimally Invasive Surgery

Undergo minimally invasive hysterectomy

PROCEDUREPelvic Lymphadenectomy

Undergo pelvic lymphadenectomy

OTHERQuestionnaire Administration

Ancillary studies

PROCEDURESentinel Lymph Node Mapping

Undergo sentinel lymph node mapping

Locations(55)

George Washington University Medical Center

Washington D.C., District of Columbia, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

UM Sylvester Comprehensive Cancer Center at Doral

Doral, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, United States

University of Miami Sylvester Comprehensive Cancer Center at Sole Mia

North Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States

Augusta University Medical Center

Augusta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

IU Health North Hospital

Carmel, Indiana, United States

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

West Jefferson Medical Center

Marrero, Louisiana, United States

East Jefferson General Hospital

Metairie, Louisiana, United States

LSU Healthcare Network / Metairie Multi-Specialty Clinic

Metairie, Louisiana, United States

Louisiana State University Health Science Center

New Orleans, Louisiana, United States

University Medical Center New Orleans

New Orleans, Louisiana, United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States

UM Upper Chesapeake Medical Center

Bel Air, Maryland, United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States

McLaren Cancer Institute-Flint

Flint, Michigan, United States

Fairview Southdale Hospital

Edina, Minnesota, United States

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, United States

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Fairview Northland Medical Center

Princeton, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

Fairview Lakes Medical Center

Wyoming, Minnesota, United States

Mercy Hospital Springfield

Springfield, Missouri, United States

Saint Vincent Healthcare

Billings, Montana, United States

Saint Vincent Frontier Cancer Center

Billings, Montana, United States

Intermountain Health West End Clinic

Billings, Montana, United States

Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, United States

Fred and Pamela Buffett Cancer Center - Kearney

Kearney, Nebraska, United States

Nebraska Medicine-Village Pointe

Omaha, Nebraska, United States

Alegent Health Bergan Mercy Medical Center

Omaha, Nebraska, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Women's Cancer Center of Nevada

Las Vegas, Nevada, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States

Paoli Memorial Hospital

Paoli, Pennsylvania, United States

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Women and Infants Hospital

Providence, Rhode Island, United States

Parkland Memorial Hospital

Dallas, Texas, United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

UT Southwestern/Simmons Cancer Center-Fort Worth

Fort Worth, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

Memorial Hermann Texas Medical Center

Houston, Texas, United States

Methodist Willowbrook Hospital

Houston, Texas, United States

Houston Methodist West Hospital

Houston, Texas, United States

UT Southwestern Clinical Center at Richardson/Plano

Richardson, Texas, United States

Houston Methodist Sugar Land Hospital

Sugar Land, Texas, United States

Houston Methodist The Woodlands Hospital

The Woodlands, Texas, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT05646316