Effectiveness of Lymph Node Mapping to Reduce the Risk of Swelling in the Legs in Patients with Stage I Endometrial Cancer
https://www.facingourrisk.org/research-clinical-trials/study/310/effectiveness-of-lymph-node-mapping-to-reduce-the-risk-of-swelling-in-the-legs-in-patients-with-stage-i-endometrial-cancer
Clinicaltrials.gov identifier:
NCT05646316 (https://clinicaltrials.gov/show/NCT05646316)
Treatment
People with stage I endometrial cancer who are having a hysterectomy
Study Contact Information:
For additional information, please contact Dr. Edward Tanner, PI at etanner4@jh.edu
About the Study
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 a specific lymph node most likely to contain cancer cells. Comparing the results of the procedures may help doctors predict the risk of long-term swelling in the legs.
What the Study Involves
Participants will be divided into one of two groups.
Group A: Participants will receive a special dye injected into the vein and undergo lymph node mapping and removal during a hysterectomy. Lymph nodes around the uterus may be removed if the mapping and removal cannot be completed. Successful mapping requires no additional removal of lymph nodes.
Group B: Participants will receive a special dye injected into the vein and undergo lymph node mapping and removal during a hysterectomy. Additional lymph nodes around the uterus are removed per standard of care.
Participants in both groups also undergo imaging as needed and optional blood sample collection throughout the study.
After completion of study intervention, participants are followed every 3 months for one year and at 18 and 24 months.
Study Sites
District of Columbia
Washington University Medical Center
Contact: 202-741-2981
Principal Investigator: Nicole P. Chappell
Florida
Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Gables
Contact: 305-243-2647
Principal Investigator: Abdulrahman Sinno
Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Contact 305-243-2647
Principal Investigator: Abdulrahman Sinno
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Contact: 305-243-2647
Principal Investigator: Abdulrahman Sinno
Plantation
UM Sylvester Comprehensive Cancer Center at Plantation
Contact: 305-243-2647
Principal Investigator: Abdulrahman Sinno
Illinois
Chicago
Northwestern University
Contact: 312-695-1301 or cancer@northwestern.edu
Principal Investigator: Emily Hinchcliff
Warrenville
Northwestern Medicine Cancer Center Warrenville
Contact: 630-352-5360 Donald.Smith3@nm.org
Principal Investigator: Emily Hinchcliff
Indiana
Carmel
IU Health North Hospital
Contact: 317-278-5632 iutrials@iu.edu
Principal Investigator: Lisa M. Landrum
Indianapolis
Indiana University/Melvin and Bren Simon Cancer Center
Louisiana
Marrero
West Jefferson Medical Center
Contact: 504-210-3539 emede1@lsuhsc.edu
Principal Investigator: Tara Castellano
Metairie
East Jefferson General Hospital
Contact: 504-210-3539 emede1@lsuhsc.edu
Principal Investigator: Tara Castellano
New Orleans
Louisiana State University Health Science Center
Contact: 504-210-3539 emede1@lsuhsc.edu
Principal Investigator: Tara Castellano
University Medical Center New Orleans
Contact: 504-210-3539 emede1@lsuhsc.edu
Principal Investigator: Tara Castellano
Maryland
Baltimore
University of Maryland/Greenebaum Cancer Center
Contact: 800-888-8823
Principal Investigator: Gautam G. Rao
Michigan
Detroit
Wayne State University/Karmanos Cancer Institute
Contact: 313-576-9790 ctoadmin@karmanos.org
Principal Investigator: Robert T. Morris
Farmington Hills
Weisberg Cancer Treatment Center
Contact: 313-576-9790 ctoadmin@karmanos.org
Principal Investigator: Robert T. Morris
Flint
McLaren Cancer Institute-Flint
Contact: 313-576-9790 ctoadmin@karmanos.org
Principal Investigator: Robert T. Morris
Minnesota
Edina
Fairview Southdale Hospital
Contact: 952-993-1517 mmcorc@healthpartners.com
Principal Investigator: Britt K. Erickson
Maple Grove
Fairview Clinics and Surgery Center Maple Grove
Contact: 952-993-1517 mmcorc@healthpartners.com
Principal Investigator: Britt K. Erickson
Maplewood
Saint John's Hospital - Healtheast
Contact: 952-993-1517 mmcorc@healthpartners.com
Principal Investigator: Britt K. Erickson
Princeton
Fairview Northland Medical Center
Contact: 952-993-1517 mmcorc@healthpartners.com
Principal Investigator: Britt K. Erickson
Saint Paul
Regions Hospital
Contact: 952-993-1517 mmcorc@healthpartners.com
Principal Investigator: Britt K. Erickson
Wyoming
Fairview Lakes Medical Center
Contact: 952-993-1517 mmcorc@healthpartners.com
Principal Investigator: Britt K. Erickson
Missouri
Springfield
Mercy Hospital Springfield
Contact: 417-269-4520
Principal Investigator: Jay W. Carlson
Nebraska
Omaha
University of Nebraska Medical Center
Contact: 402-559-6941 unmcrsa@unmc.edu
Principal Investigator: Kerry J. Rodabaugh
Nevada
Las Vegas
Women's Cancer Center of Nevada
Contact: 702-693-6870 jamador@wccenter.com
Principal Investigator: Nicola M. Spirtos
Oklahoma
Oklahoma City
University of Oklahoma Health Sciences Center
Contact: 405-271-8777 ou-clinical-trials@ouhsc.edu
Principal Investigator: Joan L. Walker
Pennsylvania
Bryn Mawr
Bryn Mawr Hospital
Contact: 484-476-2649 turzoe@mlhs.org
Principal Investigator: Deric C. Savior
Paoli
Paoli Memorial Hospital
Contact: 484-476-2649 turzoe@mlhs.org
Principal Investigator: Deric C. Savior
Wynnewood
Lankenau Medical Center
Contact: 484-476-2649 turzoe@mlhs.org
Principal Investigator: Deric C. Savior
Rhode Island
Providence
Women and Infants Hospital
Contact: 401-274-1122
Principal Investigator: Matthew T. Oliver
Texas
Dallas
Parkland Memorial Hospital
Contact: 214-590-5582 canceranswerline@UTSouthwestern.edu
Principal Investigator: Jayanthi S. Lea
UT Southwestern/Simmons Cancer Center-Dallas
Contact: 214-590-5582 canceranswerline@UTSouthwestern.edu
Principal Investigator: Jayanthi S. Lea
Richardson
UT Southwestern Clinical Center at Richardson/Plano
Contact: 972-669-7044 Suzanne.cole@utsouthwestern.edu
Principal Investigator: Jayanthi S. Lea
Virginia
Charlottesville
University of Virginia Cancer Center
Contact: 434-243-6303 uvacancertrials@hscmail.mcc.virginia.edu
Principal Investigator: Kari L. Ring
This Study is Open To:
People, aged 18 years and older, who meet the following criteria:
- Diagnosed with stage I endometrial cancer and plan to have a laparoscopic or robotic hysterectomy and lymphatic assessment as part of their primary management.
- Speak English or Spanish.
This Study is Not Open To:
People who are under the age of 18 and who:
- Had chemotherapy or immunotherapy for endometrial cancer except progestin-containing therapies and levonorgestrel-containing intrauterine device (IUD).
- Had radiation to the pelvis, groin, or lower extremities or surgery to lymph nodes in the pelvis or groin area.
- Will undergo another surgery at the same time as endometrial surgery.
- Have another disease or medical condition such as lower extremity lymphedema or chronic lower extremity swelling.
- Have lower extremity or pelvic deep venous thromboembolism (occurs when a blood clot breaks off and travels through the bloodstream, blocking a blood vessel) or lower extremity cellulitis (a bacterial skin infection) within 90 days of registration.
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.