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Spots Global Cancer Trial Database for Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer

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Trial Identification

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

Official Title: A Phase III Trial of the Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Endometrial Cancer

Study ID: NCT05646316

Study Description

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.

Detailed Description: PRIMARY OBJECTIVES: I. To compare the rates of lower extremity limb dysfunction (defined as a \>= 4-point increase in Gynecologic Cancer Lymphedema Questionnaire \[GCLQ\] symptom score from baseline) in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy: Ia. Sentinel lymph node mapping followed by side-specific lymphadenectomy on sides without a sentinel lymph node (SLN) identified according to a National Comprehensive Cancer Network (NCCN) guidelines approved algorithm (Arm 1); Ib. Sentinel lymph node mapping according to an NCCN Guidelines approved algorithm followed by bilateral pelvic +/- para-aortic lymphadenectomy (Arm 2). SECONDARY OBJECTIVE: I. To compare changes in lower extremity limb circumference in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy. II. To validate the test characteristics of a SLN mapping algorithm including SLN detection rates, rate of perioperative complications, rate of identifying lymphatic metastases, and detection of micrometastases using pathologic ultra-staging. EXPLORATORY OBJECTIVES: I. To compare adjuvant therapy decisions in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy. II. To explore the impact of patient characteristics (age, body mass index \[BMI\], race), extent of lymph node dissection, and adjuvant therapy decisions (radiation, chemotherapy) on the development of lower extremity limb dysfunction - as well as their interaction with lymph node assessment strategies. III. To evaluate the cost-effectiveness of SLN mapping with or without completion of lymphadenectomy for endometrial cancer. SAFETY OBJECTIVE: I. To compare progression free and overall survival in patients with apparent uterine confined endometrial cancer randomized to one of two lymphatic assessment strategies at time of hysterectomy. OUTLINE: Patients are randomized to 1 of 2 arms. ARM 1: Patients receive ICG dye via injection and undergo sentinel lymph node mapping during standard minimally invasive hysterectomy. Lymph nodes around the uterus may be removed if the mapping cannot be completed. Successful mapping requires no additional removal of lymph nodes. ARM 2: Patients receive ICG dye via injection and undergo sentinel lymph node mapping during standard minimally invasive hysterectomy. Additional lymph nodes around the uterus are removed per standard of care. Patients in both arms also undergo imaging as clinically indicated. After completion of study intervention, patients are followed every 3 months for one year and at 18 and 24 months.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

George Washington University Medical Center, Washington, District of Columbia, United States

Northwestern University, Chicago, Illinois, United States

Northwestern Medicine Cancer Center Warrenville, Warrenville, Illinois, United States

IU Health North Hospital, Carmel, Indiana, United States

Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States

West Jefferson Medical Center, Marrero, Louisiana, United States

East Jefferson General Hospital, Metairie, Louisiana, United States

Louisiana State University Health Science Center, New Orleans, Louisiana, United States

University Medical Center New Orleans, New Orleans, Louisiana, United States

University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States

Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States

Weisberg Cancer Treatment Center, Farmington Hills, Michigan, United States

McLaren Cancer Institute-Flint, Flint, Michigan, United States

Fairview Southdale Hospital, Edina, Minnesota, United States

Fairview Clinics and Surgery Center Maple Grove, Maple Grove, Minnesota, United States

Saint John's Hospital - Healtheast, Maplewood, Minnesota, United States

Fairview Northland Medical Center, Princeton, Minnesota, United States

Regions Hospital, Saint Paul, Minnesota, United States

Fairview Lakes Medical Center, Wyoming, Minnesota, United States

Mercy Hospital Springfield, Springfield, Missouri, United States

Alegent Health Bergan Mercy Medical Center, Omaha, Nebraska, United States

University of Nebraska Medical Center, Omaha, Nebraska, United States

Women's Cancer Center of Nevada, Las Vegas, Nevada, United States

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

Bryn Mawr Hospital, Bryn Mawr, Pennsylvania, United States

Paoli Memorial Hospital, Paoli, Pennsylvania, United States

Lankenau Medical Center, Wynnewood, Pennsylvania, United States

Women and Infants Hospital, Providence, Rhode Island, United States

Parkland Memorial Hospital, Dallas, Texas, United States

UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States

Houston Methodist Hospital, Houston, Texas, United States

Methodist Willowbrook Hospital, Houston, Texas, United States

Houston Methodist West Hospital, Houston, Texas, United States

UT Southwestern Clinical Center at Richardson/Plano, Richardson, Texas, United States

Houston Methodist Sugar Land Hospital, Sugar Land, Texas, United States

Houston Methodist The Woodlands Hospital, The Woodlands, Texas, United States

University of Virginia Cancer Center, Charlottesville, Virginia, United States

Contact Details

Name: Edward J Tanner

Affiliation: NRG Oncology

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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