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

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

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 more

Awards & 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.

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