University of Kentucky
Lexington, Kentucky, 40506, United States
NCT Number: NCT02658565
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–100 year
Female
Interventional
Not applicable
Lexington, Kentucky, 40506, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Lymphadenectomy recommended, including: obturator, iliac (internal, external, common) and aortic lymph nodes
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).
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)
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)
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)
Time frame: 5 years
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 .
Frederick R. Ueland, M.D.
Other
Surgical Staging for the Treatment of Endometrial Cancer Based on IOC
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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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