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Procedure
Sentinel Node Biopsy 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
Pivotal Trial
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4.5 years from surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4.5 years from surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Stage 1: Return to usual activities
Stage 2: Disease Free Survival
Secondary study objectives
Adjuvant Treatment Requirements
Cost Effectiveness measuring GP and specialist consultations
Cost Effectiveness measuring Intervention costs
+18 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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: 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
145 Previous Clinical Trials
69,524 Total Patients Enrolled
Queensland Centre for Gynaecological CancerLead Sponsor
16 Previous Clinical Trials
4,365 Total Patients Enrolled
Andreas Obermiar, MDStudy ChairDirector, Queensland Centre for Gynaecological Cancer Research