NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT05646316

RecruitingPhase 3

Sponsor: NRG Oncology

Conditions: Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8

Interventions: Biospecimen Collection, Diagnostic Imaging Testing, Excisional Biopsy, Indocyanine Green Solution, Minimally Invasive Surgery

Countries: United States, South Korea

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 overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (60)

Washington D.C., District of Columbia, United States
Coral Gables, Florida, United States
Deerfield Beach, Florida, United States
Doral, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
North Miami, Florida, United States
Plantation, Florida, United States
Augusta, Georgia, United States
Chicago, Illinois, United States
Warrenville, Illinois, United States
Carmel, Indiana, United States
Indianapolis, Indiana, United States
Marrero, Louisiana, United States
Metairie, Louisiana, United States
Metairie, Louisiana, United States
New Orleans, Louisiana, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Bel Air, Maryland, United States
Detroit, Michigan, United States
Farmington Hills, Michigan, United States
Flint, Michigan, United States
Edina, Minnesota, United States
Maple Grove, Minnesota, United States
Maplewood, Minnesota, United States
Princeton, Minnesota, United States
Saint Paul, Minnesota, United States
Wyoming, Minnesota, United States
Springfield, Missouri, United States
+ 30 more on CT.gov