Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
A Phase III Trial Of The Impact Of Sentinel Lymph Node Mapping On Patient Reported Lower Extremity Limb Dysfunction In Endometrial Cancer
NRG Oncology
428 participants
Dec 7, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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
Exclusion Criteria10
- 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
- For the bioimpedance sub study only: patients with implantable metal devices (i.e. defibrillator, metal joint replacements, etc.) will not be eligible to participate in the bioimpedance sub study but will be eligible to participate in the overall study
Interventions
Undergo blood sample collection
Undergo imaging
Undergo sentinel lymph node excision
Given via injection
Undergo minimally invasive hysterectomy
Undergo pelvic lymphadenectomy
Ancillary studies
Undergo sentinel lymph node mapping
Locations(54)
View Full Details on ClinicalTrials.gov
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NCT05646316