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NCT04073706 · ClinicalTrials.gov registry record · Phase 3

Sentinel Node Biopsy in Endometrial Cancer

A Phase 3 study of Surgery and Sentinel Lymph Node, sponsored by Queensland Centre for Gynaecological Cancer.

Recruiting
Registry status
Phase 3
Development phase
760
Enrollment target
19
Study locations

NCT04073706: Recruiting Phase 3 study of Surgery and Sentinel Lymph Node, sponsored by Queensland Centre for Gynaecological Cancer.

NCT04073706 is a Phase 3 study of Surgery and Sentinel Lymph Node that is actively recruiting participants, run by Queensland Centre for Gynaecological Cancer. The registered enrollment target is 760 participants, below the 52,845-participant average among 120 other Surgery trials with a reported enrollment target (99% lower). The trial reports 19 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04073706, a Phase 3 study of Surgery and Sentinel Lymph Node, is actively recruiting participants, sponsored by Queensland Centre for Gynaecological Cancer.

RECRUITING
Registry status
Phase 3
Development phase
760 participants
Enrollment target
19
Study locations

Study Summary

Endometrial cancer (EC) is the most common gynaecological cancer. Current treatment of EC typically includes removal of the uterus and to determine the extent of the disease (removal of fallopian tubes, ovaries \& if required a lymph node dissection (surgical staging)). While lymph node dissection may be valuable to guide the need for adjuvant treatment (chemo or radiotherapy) after surgery, it has been a topic of controversy for the last 30 years. In some patients it causes morbidity, specifically lymphoedema. This recently has been replaced with sentinel node biopsy (SNB). It requires an injection of a dye into the cervix with specific equipment \& surgical dissection of the lymph node in which the dye first becomes visible. Despite this promising proposition \& similar to a lymph node dissection, the value to patients, cost effectiveness \& potential harms (e.g. lymphedema) of SNB compared to no-node dissection in EC has never been established. Aim: determine the value of SNB for patients, the healthcare system and exclude detriment to patients using a randomised approach 1:1. Stage 1 - 444 patients. Stage 2 additional 316 patients. Primary Outcome Stage 1: 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. Primary Outcome Stage 2: Treatment non-inferiority as evaluated by disease-free survival status at 4.5 years post-surgery, as measured by the time interval between the date of randomisation and date of first recurrence. Confirmation of recurrent disease will be ascertained through clinical assessment, radiological work-up and/or histological results.

Primary Outcome

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.

Conditions Studied

Surgery Sentinel Lymph Node Endometrial Cancer Stage I

Interventions

  • PROCEDURE 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 omitted
  • PROCEDURE TH 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

Study Locations (19)

Queensland

  • The Wesley Hospital - Auchenflower
  • Buderim Private Hospital - Buderim
  • North West Private Hospital - Everton Park
  • Royal Brisbane and Women's Hospital - Herston
  • Mater Hospital - South Brisbane
  • Gold Coast University Hospital - Southport
  • St Andrews War Memorial Hospital - Spring Hill

São Paulo

  • Hospital de Base - São José do Rio Preto
  • Fundacao Antonio Prudente, AC Camargo Cancer Center - São Paulo
  • Hospital Israelita Albert Einstein - São Paulo

New South Wales

  • Chris O'Brien Lifehouse - Camperdown
  • Liverpool Hospital - Liverpool

Victoria

  • Mercy Hospital for Women - Heidelberg
  • Royal Women's Hospital - Parkville

Texas

  • Houston Methodist Hospital - Houston

Ciudad Autónoma de Buenos Aires (caba)

  • Hospital Britanico - Buenos Aires

Bogotá, Distrito Capital

  • Centro de tratamiento e investigación sobre Cáncer Luis Carlos Sarmiento Angulo - Bogotá

Via Pozzuolo

  • Azienda Sanitaria Universitaria Friuli Centrale (ASUFC) - Udine

Trial Details

FieldValue
Enrollment Target 760 participants
Start Date 2021-01-18
Est. Completion 2031-02
Phase Phase 3
Queensland Centre for Gynaecological Cancer

2 total trials

What NCT04073706 shows while recruiting

NCT04073706 is an interventional study that assigns participants to a tested intervention. The registered 760 participants enrollment target is mid-sized for trials with a published cap, below the 52,845-participant average among 120 other Surgery trials with a reported enrollment target (99% lower).

The record links to 3 conditions, with Surgery appearing as the primary indexed condition, and to 2 interventions - of which 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 omitted is the first listed.

NCT04073706 lists 19 locations in 9 states (Queensland, São Paulo, New South Wales).

Frequently Asked Questions

What is clinical trial NCT04073706 about?

NCT04073706 is a clinical study titled "Sentinel Node Biopsy in Endometrial Cancer". Endometrial cancer (EC) is the most common gynaecological cancer. Current treatment of EC typically includes removal of the uterus and to determine the extent of the disease (removal of fallopian tubes, ovaries \& if required a lymph node dissection (surgical staging)). While lymph node dissection m...

What is the current status of trial NCT04073706?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 760 participants. The study started on 2021-01-18. Estimated completion is 2031-02.

What conditions does trial NCT04073706 study?

This clinical trial studies the following conditions: Surgery, Sentinel Lymph Node, Endometrial Cancer Stage I.

What interventions are being tested in trial NCT04073706?

The interventions under investigation include: 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 omitted (PROCEDURE), TH 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 (PROCEDURE).

Who is sponsoring clinical trial NCT04073706?

This trial is sponsored by Queensland Centre for Gynaecological Cancer, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04073706 being conducted?

This trial has 19 study locations across Texas, Ciudad Autónoma de Buenos Aires (caba), New South Wales, Queensland, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04073706's enrollment target sits among peer trials

760 16th of 120 higher than 105 of 120 other Surgery trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Surgery trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT04073706

Source: ClinicalTrials.gov NCT04073706, the US trial registry maintained by the National Library of Medicine. NCT04073706 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.