A Phase III Trial Of The Impact Of Sentinel Lymph Node Mapping On Patient Reported Lower Extremity Limb Dysfunction In Endometrial Cancer

Status: Recruiting
Location: See all (54) locations...
Intervention Type: Procedure, Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 or Spanish

Locations
United States
Washington, D.c.
George Washington University Medical Center
SUSPENDED
Washington D.c.
Florida
UM Sylvester Comprehensive Cancer Center at Coral Gables
RECRUITING
Coral Gables
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
RECRUITING
Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Doral
RECRUITING
Doral
UM Sylvester Comprehensive Cancer Center at Kendall
RECRUITING
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
RECRUITING
Miami
UM Sylvester Comprehensive Cancer Center at Plantation
RECRUITING
Plantation
Georgia
Augusta University Medical Center
RECRUITING
Augusta
Illinois
Northwestern University
RECRUITING
Chicago
Northwestern Medicine Cancer Center Warrenville
RECRUITING
Warrenville
Indiana
IU Health North Hospital
RECRUITING
Carmel
Indiana University/Melvin and Bren Simon Cancer Center
RECRUITING
Indianapolis
Louisiana
West Jefferson Medical Center
RECRUITING
Marrero
East Jefferson General Hospital
RECRUITING
Metairie
LSU Healthcare Network / Metairie Multi-Specialty Clinic
RECRUITING
Metairie
Louisiana State University Health Science Center
RECRUITING
New Orleans
University Medical Center New Orleans
RECRUITING
New Orleans
Maryland
University of Maryland/Greenebaum Cancer Center
RECRUITING
Baltimore
UM Upper Chesapeake Medical Center
RECRUITING
Bel Air
Michigan
Wayne State University/Karmanos Cancer Institute
RECRUITING
Detroit
Weisberg Cancer Treatment Center
RECRUITING
Farmington Hills
McLaren Cancer Institute-Flint
RECRUITING
Flint
Minnesota
Fairview Southdale Hospital
RECRUITING
Edina
Fairview Clinics and Surgery Center Maple Grove
RECRUITING
Maple Grove
Saint John's Hospital - Healtheast
RECRUITING
Maplewood
Fairview Northland Medical Center
RECRUITING
Princeton
Regions Hospital
RECRUITING
Saint Paul
Fairview Lakes Medical Center
RECRUITING
Wyoming
Missouri
Mercy Hospital Springfield
RECRUITING
Springfield
Montana
Intermountain Health West End Clinic
SUSPENDED
Billings
Saint Vincent Frontier Cancer Center
SUSPENDED
Billings
Saint Vincent Healthcare
SUSPENDED
Billings
Saint James Community Hospital and Cancer Treatment Center
SUSPENDED
Butte
Nebraska
Fred and Pamela Buffett Cancer Center - Kearney
RECRUITING
Kearney
Alegent Health Bergan Mercy Medical Center
ACTIVE_NOT_RECRUITING
Omaha
Nebraska Medicine-Village Pointe
RECRUITING
Omaha
University of Nebraska Medical Center
RECRUITING
Omaha
Nevada
Women's Cancer Center of Nevada
RECRUITING
Las Vegas
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Pennsylvania
Bryn Mawr Hospital
SUSPENDED
Bryn Mawr
Paoli Memorial Hospital
SUSPENDED
Paoli
Lankenau Medical Center
SUSPENDED
Wynnewood
Rhode Island
Women and Infants Hospital
RECRUITING
Providence
Texas
Parkland Memorial Hospital
RECRUITING
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
RECRUITING
Dallas
UT Southwestern/Simmons Cancer Center-Fort Worth
RECRUITING
Fort Worth
Houston Methodist Hospital
ACTIVE_NOT_RECRUITING
Houston
Houston Methodist West Hospital
ACTIVE_NOT_RECRUITING
Houston
Memorial Hermann Texas Medical Center
SUSPENDED
Houston
Methodist Willowbrook Hospital
ACTIVE_NOT_RECRUITING
Houston
UT Southwestern Clinical Center at Richardson/Plano
RECRUITING
Richardson
Houston Methodist Sugar Land Hospital
ACTIVE_NOT_RECRUITING
Sugar Land
Houston Methodist The Woodlands Hospital
ACTIVE_NOT_RECRUITING
The Woodlands
Virginia
University of Virginia Cancer Center
SUSPENDED
Charlottesville
Time Frame
Start Date: 2022-12-07
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 428
Treatments
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.
Sponsors
Leads: NRG Oncology
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov