NCT05646316RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 7 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 428 (estimated)
- First submitted
- 2 Dec 2022
- Start date
- 7 Dec 2022
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- NRG Oncology
- Diseases
- Endometrial cancer, Sarcoma
- NCT number
- NCT05646316
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 428
- From 7 Dec 2022 to the primary completion date, 31 Oct 2026
- 60 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Patients who are going to undergo another elective surgery during the same operative event as their hysterectomy (i.e., sacrocolpopexy, cholecystectomy)
Other illness
- 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 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (60)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gachon University Gil Hospital Coordinator of this site? Confirm its status | Incheon | South Korea | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Ewha Woman's University Mokdong Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Changwon Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Suspended |
| Gangnam Severance Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Augusta University Medical Center Coordinator of this site? Confirm its status | Augusta | United States | Recruiting |
| University of Maryland/Greenebaum Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| UM Upper Chesapeake Medical Center Coordinator of this site? Confirm its status | Bel Air | United States | Recruiting |
| Intermountain Health West End Clinic Coordinator of this site? Confirm its status | Billings | United States | Active, not recruiting |
| Saint Vincent Frontier Cancer Center Coordinator of this site? Confirm its status | Billings | United States | Active, not recruiting |
| Saint Vincent Healthcare Coordinator of this site? Confirm its status | Billings | United States | Active, not recruiting |
| Bryn Mawr Hospital Coordinator of this site? Confirm its status | Bryn Mawr | United States | Suspended |
| Saint James Community Hospital and Cancer Treatment Center Coordinator of this site? Confirm its status | Butte | United States | Active, not recruiting |
| IU Health North Hospital Coordinator of this site? Confirm its status | Carmel | United States | Recruiting |
| University of Virginia Cancer Center Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| UM Sylvester Comprehensive Cancer Center at Coral Gables Coordinator of this site? Confirm its status | Coral Gables | United States | Recruiting |
| UT Southwestern/Simmons Cancer Center-Dallas Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Parkland Memorial Hospital Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach Coordinator of this site? Confirm its status | Deerfield Beach | United States | Recruiting |
| Wayne State University/Karmanos Cancer Institute Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
| UM Sylvester Comprehensive Cancer Center at Doral Coordinator of this site? Confirm its status | Doral | United States | Recruiting |
| Fairview Southdale Hospital Coordinator of this site? Confirm its status | Edina | United States | Recruiting |
| Weisberg Cancer Treatment Center Coordinator of this site? Confirm its status | Farmington Hills | United States | Recruiting |
| McLaren Cancer Institute-Flint Coordinator of this site? Confirm its status | Flint | United States | Recruiting |
| UT Southwestern/Simmons Cancer Center-Fort Worth Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| Memorial Hermann Texas Medical Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Houston Methodist Hospital Coordinator of this site? Confirm its status | Houston | United States | Active, not recruiting |
| Methodist Willowbrook Hospital Coordinator of this site? Confirm its status | Houston | United States | Active, not recruiting |
| Houston Methodist West Hospital Coordinator of this site? Confirm its status | Houston | United States | Active, not recruiting |
| Indiana University/Melvin and Bren Simon Cancer Center Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| Fred and Pamela Buffett Cancer Center - Kearney Coordinator of this site? Confirm its status | Kearney | United States | Recruiting |
| Women's Cancer Center of Nevada Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Fairview Clinics and Surgery Center Maple Grove Coordinator of this site? Confirm its status | Maple Grove | United States | Recruiting |
| Saint John's Hospital - Healtheast Coordinator of this site? Confirm its status | Maplewood | United States | Recruiting |
| West Jefferson Medical Center Coordinator of this site? Confirm its status | Marrero | United States | Recruiting |
| East Jefferson General Hospital Coordinator of this site? Confirm its status | Metairie | United States | Recruiting |
| LSU Healthcare Network / Metairie Multi-Specialty Clinic Coordinator of this site? Confirm its status | Metairie | United States | Recruiting |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| UM Sylvester Comprehensive Cancer Center at Kendall Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| University Medical Center New Orleans Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
| Louisiana State University Health Science Center Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
| University of Miami Sylvester Comprehensive Cancer Center at Sole Mia Coordinator of this site? Confirm its status | North Miami | United States | Recruiting |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Recruiting |
| Nebraska Medicine-Village Pointe Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Alegent Health Bergan Mercy Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Active, not recruiting |
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Paoli Memorial Hospital Coordinator of this site? Confirm its status | Paoli | United States | Suspended |
| UM Sylvester Comprehensive Cancer Center at Plantation Coordinator of this site? Confirm its status | Plantation | United States | Recruiting |
| Fairview Northland Medical Center Coordinator of this site? Confirm its status | Princeton | United States | Recruiting |
| Women and Infants Hospital Coordinator of this site? Confirm its status | Providence | United States | Recruiting |
| UT Southwestern Clinical Center at Richardson/Plano Coordinator of this site? Confirm its status | Richardson | United States | Recruiting |
| Regions Hospital Coordinator of this site? Confirm its status | Saint Paul | United States | Recruiting |
| Mercy Hospital Springfield Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
| Houston Methodist Sugar Land Hospital Coordinator of this site? Confirm its status | Sugar Land | United States | Active, not recruiting |
| Houston Methodist The Woodlands Hospital Coordinator of this site? Confirm its status | The Woodlands | United States | Active, not recruiting |
| Northwestern Medicine Cancer Center Warrenville Coordinator of this site? Confirm its status | Warrenville | United States | Recruiting |
| George Washington University Medical Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Suspended |
| Lankenau Medical Center Coordinator of this site? Confirm its status | Wynnewood | United States | Suspended |
| Fairview Lakes Medical Center Coordinator of this site? Confirm its status | Wyoming | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.