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New study aims to reduce leg swelling in endometrial cancer surgery

NCT ID NCT05646316

Symptom relief Sponsor: NRG Oncology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This study tests whether a less invasive lymph node procedure (sentinel mapping) can lower the risk of long-term leg swelling compared to standard lymph node removal. About 428 women with stage I endometrial cancer will be followed for 18 months after hysterectomy. The goal is to find which method better preserves leg function and quality of life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 428 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

carcinosarcoma stage I endometrioid carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stage I uterine corpus carcinoma or carcinosarcoma ajcc V8

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    50 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alegent Health Bergan Mercy Medical Center

    ACTIVE_NOT_RECRUITING

    Omaha, Nebraska, 68124, United States

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Augusta University Medical Center

    RECRUITING

    Augusta, Georgia, 30912, United States

  • Bryn Mawr Hospital

    SUSPENDED

    Bryn Mawr, Pennsylvania, 19010, United States

  • East Jefferson General Hospital

    RECRUITING

    Metairie, Louisiana, 70006, United States

  • Ewha Woman's University Mokdong Hospital

    RECRUITING

    Seoul, 07985, South Korea

  • Fairview Clinics and Surgery Center Maple Grove

    RECRUITING

    Maple Grove, Minnesota, 55369, United States

  • Fairview Lakes Medical Center

    RECRUITING

    Wyoming, Minnesota, 55092, United States

  • Fairview Northland Medical Center

    RECRUITING

    Princeton, Minnesota, 55371, United States

  • Fairview Southdale Hospital

    RECRUITING

    Edina, Minnesota, 55435, United States

  • Fred and Pamela Buffett Cancer Center - Kearney

    RECRUITING

    Kearney, Nebraska, 68845, United States

  • Gachon University Gil Hospital

    RECRUITING

    Incheon, 405-760, South Korea

  • Gangnam Severance Hospital

    RECRUITING

    Seoul, 06273, South Korea

  • George Washington University Medical Center

    SUSPENDED

    Washington D.C., District of Columbia, 20037, United States

  • Houston Methodist Hospital

    ACTIVE_NOT_RECRUITING

    Houston, Texas, 77030, United States

  • Houston Methodist Sugar Land Hospital

    ACTIVE_NOT_RECRUITING

    Sugar Land, Texas, 77479, United States

  • Houston Methodist The Woodlands Hospital

    ACTIVE_NOT_RECRUITING

    The Woodlands, Texas, 77385, United States

  • Houston Methodist West Hospital

    ACTIVE_NOT_RECRUITING

    Houston, Texas, 77094, United States

  • IU Health North Hospital

    RECRUITING

    Carmel, Indiana, 46032, United States

    Contact Email: •••••@•••••

  • Indiana University/Melvin and Bren Simon Cancer Center

    RECRUITING

    Indianapolis, Indiana, 46202, United States

    Contact Email: •••••@•••••

  • Intermountain Health West End Clinic

    ACTIVE_NOT_RECRUITING

    Billings, Montana, 59106, United States

  • LSU Healthcare Network / Metairie Multi-Specialty Clinic

    RECRUITING

    Metairie, Louisiana, 70006, United States

  • Lankenau Medical Center

    SUSPENDED

    Wynnewood, Pennsylvania, 19096, United States

  • Louisiana State University Health Science Center

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • McLaren Cancer Institute-Flint

    RECRUITING

    Flint, Michigan, 48532, United States

    Contact Email: •••••@•••••

  • Memorial Hermann Texas Medical Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Mercy Hospital Springfield

    RECRUITING

    Springfield, Missouri, 65804, United States

  • Methodist Willowbrook Hospital

    ACTIVE_NOT_RECRUITING

    Houston, Texas, 77070, United States

  • Nebraska Medicine-Village Pointe

    RECRUITING

    Omaha, Nebraska, 68118, United States

  • Northwestern Medicine Cancer Center Warrenville

    RECRUITING

    Warrenville, Illinois, 60555, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

    Contact Email: •••••@•••••

  • Paoli Memorial Hospital

    SUSPENDED

    Paoli, Pennsylvania, 19301, United States

  • Parkland Memorial Hospital

    RECRUITING

    Dallas, Texas, 75235, United States

    Contact Email: •••••@•••••

  • Regions Hospital

    RECRUITING

    Saint Paul, Minnesota, 55101, United States

  • Saint James Community Hospital and Cancer Treatment Center

    ACTIVE_NOT_RECRUITING

    Butte, Montana, 59701, United States

  • Saint John's Hospital - Healtheast

    RECRUITING

    Maplewood, Minnesota, 55109, United States

  • Saint Vincent Frontier Cancer Center

    ACTIVE_NOT_RECRUITING

    Billings, Montana, 59102, United States

  • Saint Vincent Healthcare

    ACTIVE_NOT_RECRUITING

    Billings, Montana, 59101, United States

  • Samsung Changwon Hospital

    SUSPENDED

    Seoul, Gyeongsangnam-do, 51353, South Korea

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    RECRUITING

    Coral Gables, Florida, 33146, United States

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    RECRUITING

    Deerfield Beach, Florida, 33442, United States

  • UM Sylvester Comprehensive Cancer Center at Doral

    RECRUITING

    Doral, Florida, 33166, United States

  • UM Sylvester Comprehensive Cancer Center at Kendall

    RECRUITING

    Miami, Florida, 33176, United States

  • UM Sylvester Comprehensive Cancer Center at Plantation

    RECRUITING

    Plantation, Florida, 33324, United States

  • UM Upper Chesapeake Medical Center

    RECRUITING

    Bel Air, Maryland, 21014, United States

  • UT Southwestern Clinical Center at Richardson/Plano

    RECRUITING

    Richardson, Texas, 75080, United States

  • UT Southwestern/Simmons Cancer Center-Dallas

    RECRUITING

    Dallas, Texas, 75390, United States

    Contact Email: •••••@•••••

  • UT Southwestern/Simmons Cancer Center-Fort Worth

    RECRUITING

    Fort Worth, Texas, 76104, United States

    Contact Email: •••••@•••••

  • University Medical Center New Orleans

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • University of Maryland/Greenebaum Cancer Center

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Miami Sylvester Comprehensive Cancer Center at Sole Mia

    RECRUITING

    North Miami, Florida, 33181, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Virginia Cancer Center

    RECRUITING

    Charlottesville, Virginia, 22908, United States

    Contact Email: •••••@•••••

  • Wayne State University/Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

    Contact Email: •••••@•••••

  • Weisberg Cancer Treatment Center

    RECRUITING

    Farmington Hills, Michigan, 48334, United States

    Contact Email: •••••@•••••

  • West Jefferson Medical Center

    RECRUITING

    Marrero, Louisiana, 70072, United States

  • Women and Infants Hospital

    RECRUITING

    Providence, Rhode Island, 02905, United States

  • Women's Cancer Center of Nevada

    RECRUITING

    Las Vegas, Nevada, 89106, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.