Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
NCT ID: NCT05646316
Last Updated: 2025-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
428 participants
INTERVENTIONAL
2022-12-07
2026-10-31
Brief Summary
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Detailed Description
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I. To compare the rates of lower extremity limb dysfunction (defined as a \>= 4-point increase in Gynecologic Cancer Lymphedema Questionnaire \[GCLQ\] symptom score from baseline) in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy:
Ia. Sentinel lymph node mapping and excision followed by side-specific lymphadenectomy on sides without a sentinel lymph node (SLN) identified according to a National Comprehensive Cancer Network (NCCN) guidelines approved algorithm (Arm 1); Ib. Sentinel lymph node mapping and excision according to an NCCN Guidelines approved algorithm followed by bilateral pelvic +/- para-aortic lymphadenectomy (Arm 2).
SECONDARY OBJECTIVE:
I. To compare changes in lower extremity limb circumference in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy.
II. To validate the test characteristics of a SLN mapping algorithm including SLN detection rates, rate of perioperative complications, rate of identifying lymphatic metastases, and detection of micrometastases using pathologic ultra-staging.
EXPLORATORY OBJECTIVES:
I. To compare adjuvant therapy decisions in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy.
II. To explore the impact of patient characteristics (age, body mass index \[BMI\], race), extent of lymph node dissection, and adjuvant therapy decisions (radiation, chemotherapy) on the development of lower extremity limb dysfunction - as well as their interaction with lymph node assessment strategies.
III. To evaluate the cost-effectiveness of SLN mapping with or without completion of lymphadenectomy for endometrial cancer.
SAFETY OBJECTIVE:
I. To compare progression free and overall survival in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients receive ICG dye via injection and undergo sentinel lymph node mapping and excision during standard minimally invasive hysterectomy. Lymph nodes around the uterus may be removed if the mapping and excision cannot be completed. Successful mapping requires no additional removal of lymph nodes.
ARM 2: Patients receive ICG dye via injection and undergo sentinel lymph node mapping and excision during standard minimally invasive hysterectomy. Additional lymph nodes around the uterus are removed per standard of care.
Patients in both arms also undergo imaging as clinically indicated and optional blood sample collection throughout the study.
After completion of study intervention, patients are followed every 3 months for one year and at 18 and 24 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm 1 (sentinel lymph node mapping)
Patients receive ICG dye via injection and undergo sentinel lymph node mapping and excision during standard minimally invasive hysterectomy. Lymph nodes around the uterus may be removed if the mapping and excision cannot be completed. Successful mapping requires no additional removal of lymph nodes. Patients also undergo imaging as clinically indicated and optional blood sample collection throughout the study.
Biospecimen Collection
Undergo blood sample collection
Diagnostic Imaging Testing
Undergo imaging
Excisional Biopsy
Undergo sentinel lymph node excision
Indocyanine Green Solution
Given via injection
Minimally Invasive Surgery
Undergo minimally invasive hysterectomy
Pelvic Lymphadenectomy
Undergo pelvic lymphadenectomy
Questionnaire Administration
Ancillary studies
Sentinel Lymph Node Mapping
Undergo sentinel lymph node mapping
Arm 2 (sentinel lymph node mapping, pelvic lymphadenectomy)
Patients receive ICG dye via injection and undergo sentinel lymph node mapping and excision during standard minimally invasive hysterectomy. Additional lymph nodes around the uterus are removed per standard of care. Patients also undergo imaging as clinically indicated and optional blood sample collection throughout the study.
Biospecimen Collection
Undergo blood sample collection
Diagnostic Imaging Testing
Undergo imaging
Excisional Biopsy
Undergo sentinel lymph node excision
Indocyanine Green Solution
Given via injection
Minimally Invasive Surgery
Undergo minimally invasive hysterectomy
Pelvic Lymphadenectomy
Undergo pelvic lymphadenectomy
Questionnaire Administration
Ancillary studies
Sentinel Lymph Node Mapping
Undergo sentinel lymph node mapping
Interventions
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Biospecimen Collection
Undergo blood sample collection
Diagnostic Imaging Testing
Undergo imaging
Excisional Biopsy
Undergo sentinel lymph node excision
Indocyanine Green Solution
Given via injection
Minimally Invasive Surgery
Undergo minimally invasive hysterectomy
Pelvic Lymphadenectomy
Undergo pelvic lymphadenectomy
Questionnaire Administration
Ancillary studies
Sentinel Lymph Node Mapping
Undergo sentinel lymph node mapping
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
NRG Oncology
OTHER
Responsible Party
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Principal Investigators
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Edward J Tanner
Role: PRINCIPAL_INVESTIGATOR
NRG Oncology
Locations
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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
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
Countries
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Facility Contacts
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Site Public Contact
Role: primary
Site Public Contact
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Site Public Contact
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Site Public Contact
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Site Public Contact
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Other Identifiers
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NCI-2022-05090
Identifier Type: REGISTRY
Identifier Source: secondary_id
NRG-CC010
Identifier Type: OTHER
Identifier Source: secondary_id
NRG-CC010
Identifier Type: OTHER
Identifier Source: secondary_id
NRG-CC010
Identifier Type: OTHER
Identifier Source: secondary_id
NRG-CC010
Identifier Type: -
Identifier Source: org_study_id
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