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Purpose

Complete pelvic and para-aortic lymphadenectomy performed at the time of primary surgical staging for endometrial cancer increases operative time and surgical morbidity, but appears to be necessary in most high grade and deeply invasive cancers. To date, the Mayo Clinic approach has not been reproduced, and the investigators propose to validate their algorithm at the University of Kentucky utilizing intra-operative consultation (IOC). The preliminary data at the University of Kentucky for IOC and endometrial cancer outcomes suggest that the investigators are well-suited to perform this investigation. A surgical approach that is tailored to the patient's cancer biology is rational, supported by the recent literature, and medically compelling since the co-morbidities of many obese, low-risk EC patients put them at significantly increased perioperative risk for complete lymphadenectomy.

Condition

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • All patients must be surgical candidates for complete hysterectomy and bilateral salpingo-oophorectomy and pelvic and aortic lymphadenectomy.
  • Patients must have a histologically confirmed diagnosis of endometrial cancer and no clinical evidence of extra-uterine disease on preoperative evaluation.
  • Preoperative evaluation to rule-out extra-uterine disease may include CT scan, MRI, or ultrasound. Preoperative imaging is not mandatory for study enrollment.
  • Patients may have received prior systemic chemotherapy. Such therapy must have been completed at least 5 years prior to study entry and the patient has no evidence of disease subsequent to such therapy. Patients must not have received neoadjuvant chemotherapy for the present disease.
  • Patients must have GOG performance status 0, 1, or 2.
  • Patients must have an estimated survival greater than or equal to 3 months
  • Patients must have signed an approved informed consent and HIPAA authorization.

Exclusion Criteria

  • Patients with clinical evidence of disease beyond the uterus, including presence of suspicious aortic or inguinal nodes on imaging or clinical exam.
  • Patients who have received previous vaginal, pelvic, or abdominal irradiation.
  • Patients who received chemotherapy directed at the present disease.
  • Patients who have circumstances that will not permit completion of this study or the required follow-up.
  • Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of surgical lymph node assessments.
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer within the last five years.
  • Patients with GOG Performance Grade of 3 or 4.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
Low-risk for nodal involvement
No lymphadenectomy recommended
Experimental
High-risk for nodal involvement
Lymphadenectomy recommended, including: obturator, iliac (internal, external, common) and aortic lymph nodes
  • Procedure: Lymphadenectomy
    Lymphadenectomy recommended, including: obturator, iliac (internal, external, common) and aortic lymph nodes

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40506
Contact:
Frederick Ueland, MD
859-257-1613
fuela0@uky.edu

More Details

NCT ID
NCT02658565
Status
Recruiting
Sponsor
Frederick R. Ueland, M.D.

Study Contact

Frederick Ueland, M.D.
859-257-1613
fuela0@uky.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.