Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in South Korea / NCT05646316
Recruiting Phase 3

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

NCT05646316 · tracked via the Priya Life Science South Korea tracker
Sponsor
NRG Oncology
Phase
Phase 3
Started
2022-12-07
Last updated
2026-08-07

Condition(s) studied

Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8

Investigational drug(s) / intervention(s)

Biospecimen CollectionDiagnostic Imaging TestingExcisional BiopsyIndocyanine Green Solution →Minimally Invasive SurgeryPelvic LymphadenectomyQuestionnaire AdministrationSentinel Lymph Node Mapping

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

Study 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
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Incidence of patient-reported lower extremity limb dysfunction — From 18 months post-hysterectomy after undergoing lymphatic assessment to 39 months
    The primary endpoint is the incidence of patient-reported lower extremity limb dysfunction at 18 months post-hysterectomy after undergoing lymphatic assessment according to a National Comprehensive Cancer Network guideline-based sentinel lymph node (SLN) mapping algorithm with or without completion of lymphadenectomy. The primary endpoint will be assessed using the Gynecologic Cancer Lymphedema Questionnaire (GCLQ) questionnaire. Surveys will be performed at enrollment (pre-surgery) and at 3, 6, 9, 12, and 18 months post-surgery. Patient-reported lower extremity limb dysfunction will be defined as an increase in GCLQ symptom score of at least four (4) points from baseline at any time during the 18 months follow-up. The primary null hypothesis will be evaluated with an intent-to-treat chi-squared test, adjusted for stratification factors. Proportional hazards modeling will be used to generate a hazard ratio and 95% confidence limits of Arm 1 versus Arm 2.

Trial sites (60)

FacilityCityRegionStatus
George Washington University Medical Center Washington D.C. District of Columbia Suspended
UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables Florida Recruiting
UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida Recruiting
UM Sylvester Comprehensive Cancer Center at Doral Doral Florida Recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida Recruiting
UM Sylvester Comprehensive Cancer Center at Kendall Miami Florida Recruiting
University of Miami Sylvester Comprehensive Cancer Center at Sole Mia North Miami Florida Recruiting
UM Sylvester Comprehensive Cancer Center at Plantation Plantation Florida Recruiting
Augusta University Medical Center Augusta Georgia Recruiting
Northwestern University Chicago Illinois Recruiting
Northwestern Medicine Cancer Center Warrenville Warrenville Illinois Recruiting
IU Health North Hospital Carmel Indiana Recruiting
Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana Recruiting
West Jefferson Medical Center Marrero Louisiana Recruiting
East Jefferson General Hospital Metairie Louisiana Recruiting
LSU Healthcare Network / Metairie Multi-Specialty Clinic Metairie Louisiana Recruiting
Louisiana State University Health Science Center New Orleans Louisiana Recruiting
University Medical Center New Orleans New Orleans Louisiana Recruiting
University of Maryland/Greenebaum Cancer Center Baltimore Maryland Recruiting
UM Upper Chesapeake Medical Center Bel Air Maryland Recruiting
Wayne State University/Karmanos Cancer Institute Detroit Michigan Recruiting
Weisberg Cancer Treatment Center Farmington Hills Michigan Recruiting
McLaren Cancer Institute-Flint Flint Michigan Recruiting
Fairview Southdale Hospital Edina Minnesota Recruiting
Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota Recruiting
Saint John's Hospital - Healtheast Maplewood Minnesota Recruiting
Fairview Northland Medical Center Princeton Minnesota Recruiting
Regions Hospital Saint Paul Minnesota Recruiting
Fairview Lakes Medical Center Wyoming Minnesota Recruiting
Mercy Hospital Springfield Springfield Missouri Recruiting
Saint Vincent Healthcare Billings Montana Active Not Recruiting
Saint Vincent Frontier Cancer Center Billings Montana Active Not Recruiting
Intermountain Health West End Clinic Billings Montana Active Not Recruiting
Saint James Community Hospital and Cancer Treatment Center Butte Montana Active Not Recruiting
Fred and Pamela Buffett Cancer Center - Kearney Kearney Nebraska Recruiting
Nebraska Medicine-Village Pointe Omaha Nebraska Recruiting
Alegent Health Bergan Mercy Medical Center Omaha Nebraska Active Not Recruiting
University of Nebraska Medical Center Omaha Nebraska Recruiting
Women's Cancer Center of Nevada Las Vegas Nevada Recruiting
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma Recruiting

+ 20 more sites — see the full list on the official registry below.

More NRG Oncology trials in South Korea

A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer Recruiting
Letrozole With or Without Paclitaxel and Carboplatin in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05646316 on ClinicalTrials.gov ↗ ← All trials in South Korea