Selective Surgical Staging for the Treatment of Endometrial Cancer Based on Intraoperative Consultation

January 19, 2026 updated by: Frederick R. Ueland, M.D.

Surgical Staging for the Treatment of Endometrial Cancer Based on IOC

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

401

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • University of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-free survival
Time Frame: 24 months
Recurrence-free survival rates in low-risk and high-risk subgroups of patients with endometrial cancer as classified by the use of pathology intraoperative consultation (IOC).
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 5 years
Progression-free survival rates in low-risk and high-risk subgroups of patients with endometrial cancer as classified by the use of pathology intraoperative consultation (IOC)
5 years
Disease-specific Survival
Time Frame: 5 years
Disease-specific survival rates in low-risk and high-risk subgroups of patients with endometrial cancer as classified by the use of pathology intraoperative consultation (IOC)
5 years
Overall patient survival
Time Frame: 5 years
Overall survival rates in low-risk and high-risk subgroups of patients with endometrial cancer as classified by the use of pathology intraoperative consultation (IOC)
5 years
Concordance between IOC and final pathology Incidence
Time Frame: 5 years
5 years
Perioperative morbidity and mortality
Time Frame: 5 years
Perioperative morbidity and mortality outcome will be assessed as the number of participants with Adverse Events/death which are related to treatment/surgery .
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Frederick R. Ueland, M.D.

Investigators

  • Principal Investigator: Frederick Ueland, M.D., University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2016

Primary Completion (Actual)

December 8, 2023

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

December 8, 2015

First Submitted That Met QC Criteria

January 14, 2016

First Posted (Estimated)

January 20, 2016

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-15-GYN-150

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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