BIOMarkers in Endometrial Cancer - A phase III open label randomized trial to determine the efficacy of biomarker staging as compared to conventional staging in women with presumed early-stage endometrial cancer.

Prior treatment

• Women in whom surgery with palliative intent only is planned
• Women in whom macroscopic dissemination is confirmed during surgery

Other illness

• Women with a history of pelvic or abdominal radiotherapy
• Women with secondary invasive neoplasm in the last 5 years (except non-melanoma skin cancer, breast cancer T1 N0 M0 grade 1 or 2 without any signs of recurrence or activity
• Women with iodine allergy cannot participate in the sentinel node part of the trial

Other

• FIGO stage > II pre- or peroperatively
• FIGO stage IIIA or IIIB or IV at final pathology
• Women who are pregnant
• Women in whom macroscopic dissemination is suspected at preoperative imaging

• Histologically confirmed primary carcinoma in the endometrium
• Women able to understand and comply with planned study procedures
• Women with presumed FIGO stage I-II
• Planned surgery with curative intent
• Patient must be suitable candidates for surgery
• Patient must be suitable candidates for adjuvant treatment
• ECOG performance status 0-2
• Patients who have signed an approved Informed Consent
• Age ≥ 18 years
• Subject has adequate organ function, defined as follows: Haemoglobin ≥9.0 g/dL Absolute neutrophil count (ANC) ≥1500/μL Platelets ≥100 000/μL Creatinine ≤1.5 × ULN AST and ALT ≤2.5 x ULN