← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am a candidate for surgery to remove my uterus, ovaries, fallopian tubes, and certain lymph nodes.

Select...

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

Select...

I have not had chemotherapy before surgery for my current illness.

Select...

I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Recurrence-free survival

Secondary outcome measures

Concordance between IOC and final pathology Incidence

Disease-specific Survival

Overall patient survival

+2 more

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Frederick R. Ueland, M.D.Lead Sponsor

4 Previous Clinical Trials

432 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals able to join this experiment at the present time?

"Sadly, this clinical trial is no longer recruiting according to the information posted on clinicaltrials.gov. The study was initially published in January 2016 and last updated in February 2022; however, there are 289 other medical trials that currently require participants."

Answered by AI

Who is best suited to participate in this experiment?

"This clinical trial is searching for 401 participants to test the efficacy of a potential new drug. To qualify, individuals must possess endometrial neoplasms and be between 18 and 100 years old."

Answered by AI

Are older individuals included in the parameters of this clinical trial?

"This medical trial is only accessible to people aged between 18 and 100. Those under the age of consent have access to 18 clinical trials, while those with more advanced years can participate in 280 separate studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Frederick R. Ueland, M.D. 2016. "Selective Surgical Staging for the Treatment of Endometrial Cancer Based on Intraoperative Consultation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02658565.

All > Kentucky