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OpenTrials
Completed

NCT Number: NCT01512810

Intraoperative Pathological Evaluation for Surgical Treatment & Staging for Endometrial Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Kentucky Markey Cancer Center

Lexington, Kentucky, 40536, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lymphadenectomy

Procedure

Lymphadenectomy recommended, including: obturator, iliac (internal, external, common) and aortic lymph nodes

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Frederick R. Ueland, M.D.

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Jan 19, 2012
Registry last updated
Nov 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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