A Phase III Randomized Clinical Trial Comparing Sentinel Node Biopsy With No Retroperitoneal Node Dissection in Early-Stage Endometrial Cancer

What this Trial Is About

Researchers are evaluating the role of sentinel node biopsy (SNB) compared to no retroperitoneal node dissection in women with early-stage endometrial cancer. This study aims to assess whether SNB causes any harm such as lymphoedema or morbidity, its cost-effectiveness, and if it affects disease-free survival. The trial is conducted in two stages: Stage 1 with 444 patients focuses on recovery and quality of life, while Stage 2 with an additional 316 patients examines long-term disease outcomes. Participants will undergo either total laparoscopic or robotic hysterectomy with bilateral salpingo-oophorectomy (TH BSO) combined with SNB using injected tracer dyes, or TH BSO without retroperitoneal node dissection. Some patients under 45 years with specific tumor features may keep their ovaries. Surgery may include omentectomy in high-risk cases. The SNB procedure involves identifying the first lymph node that drains the tumor area using dye injections. During the study, participants will be monitored for recovery including adverse events, lymphoedema, quality of life, and healthcare costs over 12 months. Long-term follow-up will measure disease-free survival and overall survival up to 4.5 years after surgery. Evaluations will include clinical assessments, imaging, patient questionnaires, and molecular testing. The research team will also track surgery details, hospital stays, and the need for additional treatments throughout the study period.

Sentinel Node Biopsy in Endometrial Cancer