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 (The BIOMEC trial) - BIOMEC trial

Karolinska University Hospital0 个研究点目标入组 1,037 人开始时间: 2023年7月5日最近更新: 2024年7月22日

试验速览

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•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

•FIGO stage > II pre- or peroperatively, FIGO stage IIIA or IIIB or IV at final pathology, Women with a history of pelvic or abdominal radiotherapy, Women who are pregnant, Women in whom surgery with palliative intent only is planned, 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, Women in whom macroscopic dissemination is suspected at preoperative imaging, Women in whom macroscopic dissemination is confirmed during surgery

发起方

Karolinska University Hospital