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

Recruiting now · Phase 3

Conditions studied: Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8

In brief

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.

Key facts

Study ID: NCT05646316
Run by: NRG Oncology
People needed: 428
Starts: 2022-12-07
Expected to finish: 2026-10-31
Last updated by the study team: 2026-08-07

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables, Florida, United States (enrolling)
UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach, Florida, United States (enrolling)
UM Sylvester Comprehensive Cancer Center at Doral — Doral, Florida, United States (enrolling)
University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States (enrolling)
UM Sylvester Comprehensive Cancer Center at Kendall — Miami, Florida, United States (enrolling)
University of Miami Sylvester Comprehensive Cancer Center at Sole Mia — North Miami, Florida, United States (enrolling)
UM Sylvester Comprehensive Cancer Center at Plantation — Plantation, Florida, United States (enrolling)
Augusta University Medical Center — Augusta, Georgia, United States (enrolling)
Northwestern University — Chicago, Illinois, United States (enrolling)
Northwestern Medicine Cancer Center Warrenville — Warrenville, Illinois, United States (enrolling)
IU Health North Hospital — Carmel, Indiana, United States (enrolling)
Indiana University/Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States (enrolling)
West Jefferson Medical Center — Marrero, Louisiana, United States (enrolling)
East Jefferson General Hospital — Metairie, Louisiana, United States (enrolling)
LSU Healthcare Network / Metairie Multi-Specialty Clinic — Metairie, Louisiana, United States (enrolling)
Louisiana State University Health Science Center — New Orleans, Louisiana, United States (enrolling)
University Medical Center New Orleans — New Orleans, Louisiana, United States (enrolling)
University of Maryland/Greenebaum Cancer Center — Baltimore, Maryland, United States (enrolling)
UM Upper Chesapeake Medical Center — Bel Air, Maryland, United States (enrolling)
Wayne State University/Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
Weisberg Cancer Treatment Center — Farmington Hills, Michigan, United States (enrolling)
McLaren Cancer Institute-Flint — Flint, Michigan, United States (enrolling)
Fairview Southdale Hospital — Edina, Minnesota, United States (enrolling)
Fairview Clinics and Surgery Center Maple Grove — Maple Grove, Minnesota, United States (enrolling)
Saint John's Hospital - Healtheast — Maplewood, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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