Recruiting
Phase 3

Observational Study

Sponsor:

NRG Oncology

Code:

NCT05646316

Conditions

Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Diagnostic Imaging Testing

Excisional Biopsy

Indocyanine Green Solution

Minimally Invasive Surgery

Study Details

Brief 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.

Conditions

Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8

Study ID

NCT05646316

Start date

Dec 7, 2022

Status verified date

Aug, 2026

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

428 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

Interventions

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

Primary outcome measure

  • Incidence of patient-reported lower extremity limb dysfunction [ Time Frame: From 18 months post-hysterectomy after undergoing lymphatic assessment to 39 months ]

Central Contacts and Locations

Locations

UM Sylvester Comprehensive Cancer Center at Coral Gables

Recruiting

Coral Gables, Florida, United States, 33146

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Abdulrahman Sinno

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Recruiting

Deerfield Beach, Florida, United States, 33442

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Abdulrahman Sinno

UM Sylvester Comprehensive Cancer Center at Doral

Recruiting

Doral, Florida, United States, 33166

Contacts

Site Public Contact

kginnity@med.miami.edu

Principal Investigator:

Abdulrahman Sinno

University of Miami Miller School of Medicine-Sylvester Cancer Center

Recruiting

Miami, Florida, United States, 33136

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Abdulrahman Sinno

UM Sylvester Comprehensive Cancer Center at Kendall

Recruiting

Miami, Florida, United States, 33176

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Abdulrahman Sinno

University of Miami Sylvester Comprehensive Cancer Center at Sole Mia

Recruiting

North Miami, Florida, United States, 33181

Contacts

Site Public Contact

kginnity@med.miami.edu

Principal Investigator:

Abdulrahman Sinno

UM Sylvester Comprehensive Cancer Center at Plantation

Recruiting

Plantation, Florida, United States, 33324

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Abdulrahman Sinno

Augusta University Medical Center

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Site Public Contact

706-721-2388ga_cares@augusta.edu

Principal Investigator:

Robert V. Higgins

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Site Public Contact

312-695-1301cancer@northwestern.edu

Principal Investigator:

Emily Hinchcliff

Northwestern Medicine Cancer Center Warrenville

Recruiting

Warrenville, Illinois, United States, 60555

Contacts

Site Public Contact

630-352-5360Donald.Smith3@nm.org

Principal Investigator:

Emily Hinchcliff

IU Health North Hospital

Recruiting

Carmel, Indiana, United States, 46032

Contacts

Site Public Contact

317-278-5632iutrials@iu.edu

Principal Investigator:

Jessica E. Parker

Indiana University/Melvin and Bren Simon Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Site Public Contact

317-278-5632iutrials@iu.edu

Principal Investigator:

Jessica E. Parker

West Jefferson Medical Center

Recruiting

Marrero, Louisiana, United States, 70072

Contacts

Site Public Contact

504-210-3539emede1@lsuhsc.edu

Principal Investigator:

Tara Castellano

East Jefferson General Hospital

Recruiting

Metairie, Louisiana, United States, 70006

Contacts

Site Public Contact

504-210-3539emede1@lsuhsc.edu

Principal Investigator:

Tara Castellano

LSU Healthcare Network / Metairie Multi-Specialty Clinic

Recruiting

Metairie, Louisiana, United States, 70006

Contacts

Site Public Contact

504-210-3539emede1@lsuhsc.edu

Principal Investigator:

Tara Castellano

Louisiana State University Health Science Center

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Site Public Contact

504-210-3539emede1@lsuhsc.edu

Principal Investigator:

Tara Castellano

University Medical Center New Orleans

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Site Public Contact

504-210-3539emede1@lsuhsc.edu

Principal Investigator:

Tara Castellano

University of Maryland/Greenebaum Cancer Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Site Public Contact

800-888-8823

Principal Investigator:

Gautam G. Rao

UM Upper Chesapeake Medical Center

Recruiting

Bel Air, Maryland, United States, 21014

Contacts

Site Public Contact

443-643-3010

Principal Investigator:

Gautam G. Rao

Wayne State University/Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Site Public Contact

800-527-6266ctoadmin@karmanos.org

Principal Investigator:

Robert T. Morris

Weisberg Cancer Treatment Center

Recruiting

Farmington Hills, Michigan, United States, 48334

Contacts

Site Public Contact

313-576-9790ctoadmin@karmanos.org

Principal Investigator:

Robert T. Morris

McLaren Cancer Institute-Flint

Recruiting

Flint, Michigan, United States, 48532

Contacts

Site Public Contact

313-576-9790ctoadmin@karmanos.org

Principal Investigator:

Robert T. Morris

Fairview Southdale Hospital

Recruiting

Edina, Minnesota, United States, 55435

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Britt K. Erickson

Fairview Clinics and Surgery Center Maple Grove

Recruiting

Maple Grove, Minnesota, United States, 55369

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Britt K. Erickson

Saint John's Hospital - Healtheast

Recruiting

Maplewood, Minnesota, United States, 55109

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Britt K. Erickson

Fairview Northland Medical Center

Recruiting

Princeton, Minnesota, United States, 55371

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Britt K. Erickson

Regions Hospital

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Britt K. Erickson

Fairview Lakes Medical Center

Recruiting

Wyoming, Minnesota, United States, 55092

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Britt K. Erickson

Mercy Hospital Springfield

Recruiting

Springfield, Missouri, United States, 65804

Contacts

Site Public Contact

417-269-4520

Principal Investigator:

Jay W. Carlson

Fred and Pamela Buffett Cancer Center - Kearney

Recruiting

Kearney, Nebraska, United States, 68845

Contacts

Site Public Contact

402-559-6941unmcrsa@unmc.edu

Principal Investigator:

Kerry J. Rodabaugh

Nebraska Medicine-Village Pointe

Recruiting

Omaha, Nebraska, United States, 68118

Contacts

Site Public Contact

402-559-5600

Principal Investigator:

Kerry J. Rodabaugh

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Site Public Contact

402-559-6941unmcrsa@unmc.edu

Principal Investigator:

Kerry J. Rodabaugh

Women's Cancer Center of Nevada

Recruiting

Las Vegas, Nevada, United States, 89106

Contacts

Site Public Contact

702-851-4672

Principal Investigator:

Nicola M. Spirtos

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Site Public Contact

405-271-8777ou-clinical-trials@ouhsc.edu

Principal Investigator:

Christina Washington

Women and Infants Hospital

Recruiting

Providence, Rhode Island, United States, 02905

Contacts

Site Public Contact

401-274-1122

Principal Investigator:

Matthew T. Oliver

Parkland Memorial Hospital

Recruiting

Dallas, Texas, United States, 75235

Contacts

Site Public Contact

214-590-5582canceranswerline@UTSouthwestern.edu

Principal Investigator:

Jayanthi S. Lea

UT Southwestern/Simmons Cancer Center-Dallas

Recruiting

Dallas, Texas, United States, 75390

Contacts

Site Public Contact

214-648-7097canceranswerline@UTSouthwestern.edu

Principal Investigator:

Jayanthi S. Lea

UT Southwestern/Simmons Cancer Center-Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Site Public Contact

214-648-7097canceranswerline@UTSouthwestern.edu

Principal Investigator:

Jayanthi S. Lea

Memorial Hermann Texas Medical Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Site Public Contact

713-792-3245

Principal Investigator:

Joseph A. Lucci

UT Southwestern Clinical Center at Richardson/Plano

Recruiting

Richardson, Texas, United States, 75080

Contacts

Site Public Contact

972-669-7044Suzanne.cole@utsouthwestern.edu

Principal Investigator:

Jayanthi S. Lea

University of Virginia Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Site Public Contact

434-243-6303uvacancertrials@hscmail.mcc.virginia.edu

Principal Investigator:

Kari L. Ring

More Information

Sponsor

NRG Oncology

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by NRG Oncology on 2026-08-07.