Sentinel Node Biopsy in Endometrial Cancer

This study is looking at the best way to treat early-stage endometrial cancer (cancer of the lining of the uterus). Doctors usually remove the uterus, fallopian tubes, and ovaries, and sometimes lymph nodes. Removing lymph nodes can sometimes cause side effects like swelling (lymphoedema). This study compares two surgical approaches: one that uses a special dye (ICG +/- Methylene Blue Dye) to find and remove only the first lymph nodes (sentinel node biopsy, or SNB) that cancer might spread to, and another that removes the uterus, tubes, and ovaries without removing lymph nodes. The goal is to see if SNB is as safe and effective, and doesn't cause more problems or costs, compared to not removing lymph nodes. You may be able to join if you are a woman over 18 with early-stage endometrial cancer.

Study design
This is an interventional study planning to enroll 760 participants. It compares two different surgical procedures for endometrial cancer.
What's involved
Participants will undergo surgery, either with a sentinel node biopsy or without retroperitoneal node dissection. Recovery will be measured at 12 months, and disease-free survival at 4.5 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 4.5 years after surgery to assess disease-free survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04073706

Sentinel Node Biopsy in Endometrial Cancer

Recruiting
PHASE3Ages 18+InterventionalTreatment
Queensland Centre for Gynaecological Cancer
~760 participants
Updated 2026-01-30 on ClinicalTrials.gov
What's tested:TH BSO with SNB Note: If participants (≤45yo), Grade 1 endometrial adenocarcinoma with myometrial invasion <50%, wish to retain their ovaries a BSO may be omittedTH BSO without retroperitoneal node dissection Note: If participants (≤45yo), Grade 1 endometrial adenocarcinoma with myometrial invasion <50%, wish to retain their ovaries a BSO may be omitted

At a glance

Recruiting sites
16 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Stage 1: Return to usual activities
Measured over 12 months from surgery
+1 more outcome measured
Endometrial Cancer Stage I
Sentinel Lymph Node
Surgery
19 sites across 9 states
Queensland7
São Paulo3
New South Wales2
Victoria2
Texas1
Ciudad Autónoma de Buenos Aires (caba)1
Bogotá, Distrito Capital1
Via Pozzuolo1
  • Andreas Obermair, Prof · STUDY_CHAIR · Director, Queensland Centre for Gynaecological Cancer Research

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  • Stage 1: Return to usual activities12 months from surgery

    Proportion of participants returning to usual daily activities at 12 months from surgery using the EQ-5D which will determine when women in both groups can return to their usual activities.

  • Stage 2: Disease Free Survival4.5 years from surgery

    Compare disease-free survival for participants randomised to receive hysterectomy, bilateral salpingo-oophorectomy with SNB compared to participants randomised to hysterectomy, bilateral salpingo-oophorectomy without retroperitoneal node dissection