Condition: Endometrial Cancer Stage I · Sentinel Lymph Node · Surgery · Sponsor: Queensland Centre for Gynaecological 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 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 m…
This description comes directly from the study's public registry record.
Grace Ngiam · +61 7 3346 5590 · endo3trial@uq.edu.au
Sara Baniahmadi · +61733465073 · sara.baniahmadi@health.qld.gov.au
Always discuss trial participation with your own doctor first.
| Houston Methodist Hospital | Houston, Texas, United States | Recruiting |
| Hospital Britanico | Buenos Aires, Ciudad Autónoma de Buenos Aires (caba), Argentina | Not Yet Recruiting |
| Chris O'Brien Lifehouse | Camperdown, New South Wales, Australia | Recruiting |
| Liverpool Hospital | Liverpool, New South Wales, Australia | Recruiting |
| The Wesley Hospital | Auchenflower, Queensland, Australia | Recruiting |
| Buderim Private Hospital | Buderim, Queensland, Australia | Recruiting |
| North West Private Hospital | Everton Park, Queensland, Australia | Recruiting |
| Royal Brisbane and Women's Hospital | Herston, Queensland, Australia | Recruiting |
| Mater Hospital | South Brisbane, Queensland, Australia | Recruiting |
| Gold Coast University Hospital | Southport, Queensland, Australia | Not Yet Recruiting |
| St Andrews War Memorial Hospital | Spring Hill, Queensland, Australia | Recruiting |
| Mercy Hospital for Women | Heidelberg, Victoria, Australia | Recruiting |
+ 7 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04073706