Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 760 participants |
| Start Date | 2021-01-18 |
| Est. Completion | 2031-02 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04073706
The ClinicalTrials.gov registry entry for NCT04073706 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 760 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 52,845-participant average among 120 other Surgery trials with a reported enrollment target (99% lower). The listed sponsor is Queensland Centre for Gynaecological Cancer, which has 2 total studies on file at ClinicalTrials.gov.
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 reports 19 study locations spanning 9 distinct geographic areas - top geographies include 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
Similar trials for Surgery
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.
-
NO During CPB in Neonates to Reduce Risk of AKI
RECRUITING · Phase 3
-
Post-Discharge Risk-Based Management in Patients Undergoing High-Risk Elective Major Cancer Operations (PRS II)
RECRUITING · Phase 3
-
The HeLiX (Hemorrhage During Liver Resection: traneXamic Acid) Trial
ACTIVE NOT RECRUITING · Phase 3
-
Evaluating Outcomes in Cardiac Surgery Patients Who Receive Sugammadex vs. Placebo
ACTIVE NOT RECRUITING · Phase 3
-
Study of Recovery of Strength After Surgery Comparing Two Different Medications for Reversal of Muscle Relaxant
COMPLETED · Phase 3
-
Thoracic Epidural Analgesia vs Surgical Site Infiltration With Liposomal Bupivacaine Following Open Gynecologic Surgery
COMPLETED · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.