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Surgical Lymph Node Removal for Endometrial Cancer

N/A
Waitlist Available
Led By Frederick Ueland, M.D.
Research Sponsored by Frederick R. Ueland, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of surgical lymph node assessments
Patients with clinical evidence of disease beyond the uterus, including presence of suspicious aortic or inguinal nodes on imaging or clinical exam
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is investigating whether or not a complete pelvic and para-aortic lymphadenectomy, which is a removal of the lymph nodes in the pelvis and around the aorta, is necessary for most high grade and deeply invasive endometrial cancers. The Mayo Clinic approach has not been reproduced, so 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.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
While specific side effects aren't listed, lymphadenectomy can generally lead to increased operative time and potential surgical complications such as infection risk, bleeding, blood clots, and injury to surrounding organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a candidate for surgery to remove my uterus, ovaries, fallopian tubes, and certain lymph nodes.
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My cancer diagnosis is endometrial cancer, and it hasn't spread outside the uterus.
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I have not had chemotherapy before surgery for my current illness.
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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a unique kidney condition that might affect surgery.
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My cancer has spread beyond the uterus, including to lymph nodes.
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I have had radiation therapy in the vaginal, pelvic, or abdominal area.
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I have received chemotherapy for my current illness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Recurrence-free survival
Secondary study objectives
Disease-specific Survival
Overall patient survival
Perioperative morbidity and mortality
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lymphadenectomy
2021
Completed Phase 2
~1480

Find a Location

Who is running the clinical trial?

Frederick R. Ueland, M.D.Lead Sponsor
5 Previous Clinical Trials
445 Total Patients Enrolled
2 Trials studying Endometrial Cancer
238 Patients Enrolled for Endometrial Cancer
Frederick Ueland, M.D.Principal InvestigatorUniversity of Kentucky
1 Previous Clinical Trials
200 Total Patients Enrolled
1 Trials studying Endometrial Cancer
200 Patients Enrolled for Endometrial Cancer

Media Library

Lymphadenectomy Clinical Trial Eligibility Overview. Trial Name: NCT02658565 — N/A
Endometrial Cancer Research Study Groups: Low-risk for nodal involvement, High-risk for nodal involvement
Endometrial Cancer Clinical Trial 2023: Lymphadenectomy Highlights & Side Effects. Trial Name: NCT02658565 — N/A
Lymphadenectomy 2023 Treatment Timeline for Medical Study. Trial Name: NCT02658565 — N/A
~41 spots leftby Dec 2025
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