Sentinel Node Biopsy in Endometrial Cancer (NCT04073706)
A Phase III Randomised Clinical Trial Comparing Sentinel Node Biopsy With No Retroperitoneal Node Dissection in Apparent Early-Stage Endometrial Cancer
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Houston Methodist Hospital — Houston, Texas
Age range: 18 Years
🧪 Interventions in This Study
- 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)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (19 Sites)
- Houston Methodist Hospital — Houston, Texas
- Hospital Britanico — Buenos Aires, Ciudad Autónoma de Buenos Aires (caba)
- Chris O'Brien Lifehouse — Camperdown, New South Wales
- Liverpool Hospital — Liverpool, New South Wales
- The Wesley Hospital — Auchenflower, Queensland
- Buderim Private Hospital — Buderim, Queensland
- North West Private Hospital — Everton Park, Queensland
- Royal Brisbane and Women's Hospital — Herston, Queensland
- Mater Hospital — South Brisbane, Queensland
- Gold Coast University Hospital — Southport, Queensland
- St Andrews War Memorial Hospital — Spring Hill, Queensland
- Mercy Hospital for Women — Heidelberg, Victoria
- Royal Women's Hospital — Parkville, Victoria
- Hospital de Base — São José do Rio Preto, São Paulo
- Fundacao Antonio Prudente, AC Camargo Cancer Center — São Paulo, São Paulo
- Hospital Israelita Albert Einstein — São Paulo, São Paulo
- Centro de tratamiento e investigación sobre Cáncer Luis Carlos Sarmiento Angulo — Bogotá, Bogotá, Distrito Capital
- Azienda Sanitaria Universitaria Friuli Centrale (ASUFC) — Udine, Via Pozzuolo
- National University Hospital and National University Cancer Institute — Singapore, NUH Zone B
📞 Contact the Study Coordinator
Phone: +61 7 3346 5590
Email: endo3trial@uq.edu.au
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Endometrial Cancer Stage I clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.