Actively Recruiting

Phase 3
Age: 18Years +
FEMALE
NCT05646316

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

Led by NRG Oncology · Updated on 2026-03-27

428

Participants Needed

55

Research Sites

203 weeks

Total Duration

On this page

Sponsors

N

NRG Oncology

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically proven diagnosis of endometrial cancer based on endometrial sampling with plan for laparoscopic or robotic hysterectomy and lymphatic assessment
  • Biopsy performed within 90 days prior to registration
  • Clinical stage I endometrial cancer with no signs of metastatic disease
  • Age 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  • Prior or concurrent malignancies allowed if they do not interfere with study safety or efficacy
  • Patient or authorized representative must provide informed consent
  • Patient must speak English, Spanish, or Korean
Not Eligible

You will not qualify if you...

  • Not a candidate for pelvic lymphadenectomy due to medical issues or technical challenges
  • Prior chemotherapy or immunotherapy for endometrial cancer (except certain progestin therapies)
  • History of radiation to pelvis, groin, lower extremities, or surgery to pelvic or inguinal lymph nodes
  • Scheduled for other elective surgery during the same operation as hysterectomy
  • Severe active conditions including history of lower extremity lymphedema, chronic swelling, recent deep vein thrombosis (within 90 days), or lower extremity cellulitis (within 90 days)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 55 locations

1

George Washington University Medical Center

Washington D.C., District of Columbia, United States, 20037

Suspended

2

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States, 33146

Actively Recruiting

3

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States, 33442

Actively Recruiting

4

UM Sylvester Comprehensive Cancer Center at Doral

Doral, Florida, United States, 33166

Actively Recruiting

5

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States, 33136

Actively Recruiting

6

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, United States, 33176

Actively Recruiting

7

University of Miami Sylvester Comprehensive Cancer Center at Sole Mia

North Miami, Florida, United States, 33181

Actively Recruiting

8

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States, 33324

Actively Recruiting

9

Augusta University Medical Center

Augusta, Georgia, United States, 30912

Actively Recruiting

10

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

11

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States, 60555

Actively Recruiting

12

IU Health North Hospital

Carmel, Indiana, United States, 46032

Actively Recruiting

13

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States, 46202

Actively Recruiting

14

West Jefferson Medical Center

Marrero, Louisiana, United States, 70072

Actively Recruiting

15

East Jefferson General Hospital

Metairie, Louisiana, United States, 70006

Actively Recruiting

16

LSU Healthcare Network / Metairie Multi-Specialty Clinic

Metairie, Louisiana, United States, 70006

Actively Recruiting

17

Louisiana State University Health Science Center

New Orleans, Louisiana, United States, 70112

Actively Recruiting

18

University Medical Center New Orleans

New Orleans, Louisiana, United States, 70112

Actively Recruiting

19

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, United States, 21201

Actively Recruiting

20

UM Upper Chesapeake Medical Center

Bel Air, Maryland, United States, 21014

Actively Recruiting

21

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

Actively Recruiting

22

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States, 48334

Actively Recruiting

23

McLaren Cancer Institute-Flint

Flint, Michigan, United States, 48532

Actively Recruiting

24

Fairview Southdale Hospital

Edina, Minnesota, United States, 55435

Actively Recruiting

25

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, United States, 55369

Actively Recruiting

26

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States, 55109

Actively Recruiting

27

Fairview Northland Medical Center

Princeton, Minnesota, United States, 55371

Actively Recruiting

28

Regions Hospital

Saint Paul, Minnesota, United States, 55101

Actively Recruiting

29

Fairview Lakes Medical Center

Wyoming, Minnesota, United States, 55092

Actively Recruiting

30

Mercy Hospital Springfield

Springfield, Missouri, United States, 65804

Actively Recruiting

31

Saint Vincent Healthcare

Billings, Montana, United States, 59101

Active, Not Recruiting

32

Saint Vincent Frontier Cancer Center

Billings, Montana, United States, 59102

Active, Not Recruiting

33

Intermountain Health West End Clinic

Billings, Montana, United States, 59106

Active, Not Recruiting

34

Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, United States, 59701

Active, Not Recruiting

35

Fred and Pamela Buffett Cancer Center - Kearney

Kearney, Nebraska, United States, 68845

Actively Recruiting

36

Nebraska Medicine-Village Pointe

Omaha, Nebraska, United States, 68118

Actively Recruiting

37

Alegent Health Bergan Mercy Medical Center

Omaha, Nebraska, United States, 68124

Active, Not Recruiting

38

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

Actively Recruiting

39

Women's Cancer Center of Nevada

Las Vegas, Nevada, United States, 89106

Actively Recruiting

40

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

41

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States, 19010

Suspended

42

Paoli Memorial Hospital

Paoli, Pennsylvania, United States, 19301

Suspended

43

Lankenau Medical Center

Wynnewood, Pennsylvania, United States, 19096

Suspended

44

Women and Infants Hospital

Providence, Rhode Island, United States, 02905

Actively Recruiting

45

Parkland Memorial Hospital

Dallas, Texas, United States, 75235

Actively Recruiting

46

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States, 75390

Actively Recruiting

47

UT Southwestern/Simmons Cancer Center-Fort Worth

Fort Worth, Texas, United States, 76104

Actively Recruiting

48

Houston Methodist Hospital

Houston, Texas, United States, 77030

Active, Not Recruiting

49

Memorial Hermann Texas Medical Center

Houston, Texas, United States, 77030

Actively Recruiting

50

Methodist Willowbrook Hospital

Houston, Texas, United States, 77070

Active, Not Recruiting

51

Houston Methodist West Hospital

Houston, Texas, United States, 77094

Active, Not Recruiting

52

UT Southwestern Clinical Center at Richardson/Plano

Richardson, Texas, United States, 75080

Actively Recruiting

53

Houston Methodist Sugar Land Hospital

Sugar Land, Texas, United States, 77479

Active, Not Recruiting

54

Houston Methodist The Woodlands Hospital

The Woodlands, Texas, United States, 77385

Active, Not Recruiting

55

University of Virginia Cancer Center

Charlottesville, Virginia, United States, 22908

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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