Surgical Lymph Node Removal for Endometrial Cancer

Recruiting in Palo Alto (17 mi)

Overseen byFrederick R. Ueland

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Frederick R. Ueland, M.D.

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Frederick R. Ueland

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for individuals with endometrial cancer who are fit for surgery, have a life expectancy of at least 3 months, and no evidence of disease spread outside the uterus. They must not have had chemotherapy for their current cancer or any invasive cancers (except non-melanoma skin cancer) in the last five years.

Inclusion Criteria

My cancer diagnosis is endometrial cancer, and it hasn't spread outside the uterus.

Patients must have an estimated survival greater than or equal to 3 months

Patients must have signed an approved informed consent and HIPAA authorization

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Exclusion Criteria

Patients with GOG Performance Grade of 3 or 4

I have a unique kidney condition that might affect surgery.

I have not had any cancer except for non-melanoma skin cancer in the last 5 years.

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Treatment Details

Interventions

Lymphadenectomy (Surgery)

Trial OverviewThe study tests a surgical procedure called lymphadenectomy during primary surgery for endometrial cancer. It aims to validate an approach that tailors surgery based on intraoperative consultation to potentially reduce risks associated with complete lymphadenectomy.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: High-risk for nodal involvementExperimental Treatment1 Intervention

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

Group II: Low-risk for nodal involvementActive Control1 Intervention

No lymphadenectomy recommended