Health Trials

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

ConditionStage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNRG Oncology

About this trial

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 criteria

Qualifiers

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

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Diagnostic Imaging Testing
  • Excisional Biopsy
  • Indocyanine Green Solution
  • Minimally Invasive Surgery
  • Pelvic Lymphadenectomy
  • Questionnaire Administration
  • Sentinel Lymph Node Mapping

Treatment groups

428 Participants
are divided into 2 treatment groups

Sponsors and collaborators

NRG Oncology

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov