STATEC is international, randomised, multi-centre, non-inferiority surgical trial, in patients at high risk endometrial cancer, randomised pre-operatively to either no LAD or to pelvic and para-aortic LAD. The primary aim of the study is to determine whether staging LAD, used to restrict adjuvant therapy to node positive women only, is non-inferior to adjuvant therapy given routinely to all women in this patient population (as determined by uterine risk factors).Secondary aims are to determine PFS and relapse rate (pelvic and distant), treatment side effects, including quality of life measures, cost effectiveness, the accuracy rates of sentinel node biopsy compared to complete node dissection, including whether it is prognostic in terms of survival, and the contribution of lymphadenectomy and adjuvant therapy (with or without lymphadenectomy) to incidence of lymphoedema.

Thriteen centres in Australia and new Zealand have expressed interest in this trial, which will have an accrual of approximately 2000 patients from the UK, Netherlands, and ANZ. Norway and Korea have also expressed interest.

Key inclusion criteria are high grade endometrial cancers, with surgery to be performed within 5 weeks of randomization and patients able to undergo adjuvant treatment with XRT AND chemotherapy within 8 weeks of surgery. Exclusion criteria are grossly enlarged nodes on pre-op imaging, invasion of cervical stroma, macroscopic disease outside uterus on imaging, and small cell carcinoma with neuroendocrine differentiation. Patients will be randomised preoperatively and adjuvant treatment will be prespecified for all patients for each site, from a list of evidence based options.

There will be two optional substudies, a sentinel LN study and a lymphoedema substudy. The protocol has now been finalised will be submitted to UK ethics. Once approved, then ethical approval can begin in ANZ.