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Treatment of Endometrial Cancer Utilizing Pathology Intraoperative Consultation to Determine Extent of Surgical Staging

Phase 2
18 Years
Open (Enrolling)
Endometrial Cancer

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Trial Information

Treatment of Endometrial Cancer Utilizing Pathology Intraoperative Consultation to Determine Extent of Surgical Staging

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 who have met the pre-entry requirements specified in Section 7.0.

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recurrence-free survival

Outcome Description:

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).

Outcome Time Frame:

24 months

Safety Issue:



United States: Institutional Review Board

Study ID:




Start Date:

January 2012

Completion Date:

January 2015

Related Keywords:

  • Endometrial Cancer
  • Endometrial
  • Cancer
  • Intraoperative Consultation
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma



University of Kentucky Markey Cancer Center Lexington, Kentucky  40536