Everton Park

Endometrial cancer is the most common gynecological cancer, and this trial focuses on early-stage disease confined to the uterus. Researchers are evaluating the value of sentinel node biopsy (SNB) compared to no retroperitoneal lymph node dissection in treatment. The study aims to determine if SNB affects patient outcomes, costs, and potential harms such as lymphedema, while also assessing disease-free survival over time. This is a Phase III randomized clinical trial designed to clarify these important questions. Participants will be randomly assigned to one of two groups: one receiving hysterectomy and removal of fallopian tubes and ovaries with SNB, and the other receiving the same surgery without retroperitoneal node dissection. The SNB procedure involves injecting a tracer dye near the tumor to identify the first lymph node(s) that drain the area, which are then surgically removed. For some younger women with less invasive cancer, ovary removal may be omitted. Treatment details, including surgery and biopsy procedures, will be carefully followed. Throughout the study, participants will be monitored for recovery and side effects such as lymphoedema, quality of life, and adverse events. Researchers will use clinical exams, imaging, and pathology to check for disease recurrence up to 4.5 years after surgery. Other assessments include cost-effectiveness, patient-reported outcomes, and survival. The primary outcomes are the time to return to usual activities at 12 months and disease-free survival at 4.5 years. Safety and health will be closely tracked, with a total follow-up period extending beyond four years.