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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02658565
Recruitment Status : Recruiting
First Posted : January 20, 2016
Last Update Posted : December 8, 2020
Sponsor:
Information provided by (Responsible Party):
Frederick R. Ueland, M.D., University of Kentucky

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Endometrial Cancer Procedure: Lymphadenectomy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Surgical Staging for the Treatment of Endometrial Cancer Based on IOC
Study Start Date : January 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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).


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 24 months ]
    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)

  2. Disease-specific Survival [ Time Frame: 24 months ]
    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)

  3. Overall patient survival [ Time Frame: 24 months ]
    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)

  4. Concordance between IOC and final pathology Incidence [ Time Frame: 24 months ]
  5. Perioperative morbidity and mortality [ Time Frame: 24 months ]
    Perioperative morbidity and mortality outcome will be assessed as the number of participants with Adverse Events/death which are related to treatment/surgery .


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes 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 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658565


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

Locations
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United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40506
Contact: Frederick Ueland, MD    859-257-1613    fuela0@uky.edu   
Sponsors and Collaborators
Frederick R. Ueland, M.D.
More Information
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Responsible Party: Frederick R. Ueland, M.D., Professor, Obstetrics and Gynecology, University of Kentucky
ClinicalTrials.gov Identifier: NCT02658565    
Other Study ID Numbers: MCC-15-GYN-150
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Frederick R. Ueland, M.D., University of Kentucky:
Intraoperative Consultation
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Uterine Diseases