Treatment of Endometrial Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Kentucky
Sponsor:
Information provided by (Responsible Party):
Fred Ueland, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01512810
First received: January 13, 2012
Last updated: April 18, 2014
Last verified: April 2014
  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 Intervention Phase
Endometrial Cancer
Procedure: Lymphadenectomy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Endometrial Cancer Utilizing Pathology Intraoperative Consultation to Determine Extent of Surgical Staging

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Recurrence-free survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 200
Study Start Date: January 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512810

Contacts
Contact: Frederick Ueland, M.D. 859-257-1613 fuela0@uky.edu
Contact: Ellixson Shar 859-323-3975 swelli2@uky.edu

Locations
United States, Kentucky
University of Kentucky Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Fred Ueland
  More Information

No publications provided

Responsible Party: Fred Ueland, Professor, Obstetrics and Gynecology, University of Kentucky
ClinicalTrials.gov Identifier: NCT01512810     History of Changes
Other Study ID Numbers: 11-GYN-130-MCC
Study First Received: January 13, 2012
Last Updated: April 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kentucky:
Endometrial
Cancer
Intraoperative Consultation

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 30, 2014