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Procedure

TH BSO with SNB for Endometrial Cancer (ENDO-3 Trial)

Phase 3
Recruiting
Research Sponsored by Queensland Centre for Gynaecological Cancer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4.5 years from surgery
Awards & highlights

ENDO-3 Trial Summary

This trial aims to determine the value of using sentinel node biopsy (SNB) compared to traditional lymph node dissection in patients with endometrial cancer. The study will involve 444 patients in the

Who is the study for?
This trial is for women over 18 with early-stage endometrial cancer, confirmed by tissue analysis. They should be physically able to undergo laparoscopic or robotic surgery and have no signs of cancer outside the uterus. Women under 45 wishing to keep their ovaries can join if they have a specific low-grade tumor with limited invasion.Check my eligibility
What is being tested?
The study compares traditional surgical removal of reproductive organs in endometrial cancer patients with and without sentinel node biopsy (SNB), which uses dye to identify key lymph nodes for removal. The aim is to see if SNB can replace more extensive surgery without compromising patient outcomes.See study design
What are the potential side effects?
Potential side effects include risks associated with general anesthesia, bleeding, infection from surgery, and specifically lymphoedema (swelling caused by lymph fluid) as a result of the sentinel node biopsy procedure.

ENDO-3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4.5 years from surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4.5 years from surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Stage 1: Return to usual activities
Stage 2: Disease Free Survival
Secondary outcome measures
Adjuvant Treatment Requirements
Cost Effectiveness measuring GP and specialist consultations
Cost Effectiveness measuring Intervention costs
+18 more

ENDO-3 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TH BSO with SNBExperimental Treatment1 Intervention
Total Laparoscopic/Robotic Hysterectomy, Bilateral Salpingo-Oophorectomy (TH BSO) with Sentinel Node Biopsy (SNB) using Indocyanine Green (ICG)+/- Methylene Blue Dye (+/- omentectomy in high risk cell types) Note: If participants (≤45 years of age), have Grade 1 endometrial adenocarcinoma (EAC) with myometrial invasion <50% (by MRI) and wish to retain their ovaries a BSO may be omitted.
Group II: TH BSO without retroperitoneal node dissectionActive Control1 Intervention
Total Laparoscopic/Robotic Hysterectomy, Bilateral Salpingo-Oophorectomy (TH BSO) without retroperitoneal node dissection (+/- omentectomy in high risk cell types) Note: If participants (≤45 years of age), have Grade 1 endometrial adenocarcinoma (EAC) with myometrial invasion <50% (by MRI) and wish to retain their ovaries a BSO may be omitted.

Find a Location

Who is running the clinical trial?

The University of QueenslandOTHER
140 Previous Clinical Trials
65,456 Total Patients Enrolled
2 Trials studying Endometrial Cancer
836 Patients Enrolled for Endometrial Cancer
Queensland Centre for Gynaecological CancerLead Sponsor
15 Previous Clinical Trials
4,125 Total Patients Enrolled
5 Trials studying Endometrial Cancer
1,761 Patients Enrolled for Endometrial Cancer
Andreas Obermiar, MDStudy ChairDirector, Queensland Centre for Gynaecological Cancer Research

Frequently Asked Questions

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

Are there a multitude of medical facilities in Canada conducting this clinical trial?

"Nineteen medical facilities, such as North West Private Hospital in Everton Park and Houston Methodist Hospital in Houston, along with St George Hospital in Kogarah and 16 additional sites, are open for participant enrollment."

Answered by AI

What is the current number of individuals being enrolled in this research study?

"A total of 760 eligible individuals are sought to partake in this research endeavor. Patients have the opportunity to enroll at diverse locations such as North West Private Hospital situated in Everton Park, Queensland and Houston Methodist Hospital located in Houston, Texas."

Answered by AI

Is this research study currently accepting new participants?

"As per clinicaltrials.gov, this research endeavor is presently in pursuit of suitable participants. The trial listing was originally made public on January 18th, 2021 and underwent its most recent update on March 24th, 2024."

Answered by AI

Has the combination of TH BSO with SNB received clearance from the FDA?

"Based on our assessment, the safety ranking assigned to TH BSO with SNB is 3. This rating reflects a Phase 3 trial status and signifies existing efficacy data along with comprehensive safety records."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Sentinel Node Biopsy in Endometrial Cancer
2021. "Sentinel Node Biopsy in Endometrial Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04073706.
All > Uterine Cancer
~507 spots leftby Jan 2031
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