A phase III randomised double-blind study comparing Sorafenib with placebo in patients with resected primary renal cell carcinoma at high or intermediate risk of relapse.

Medical Research Council0 个研究点目标入组 1,711 人开始时间: 2009年1月21日最近更新: 2020年10月19日

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•Histologically proven renal cell carcinoma. No evidence of residual macroscopic disease on post-operative Computerised Tomography (CT) scan after resection of renal cell carcinoma. Patients with clear cell or non-clear cell tumours are eligible. Patients with intermediate or high risk per the Leibovich score 3 to 11. Subjects must be >18 years in age. Women of childbearing age must have a negative pregnancy test and must use adequate contraception during the treatment phase of hte study and for 9 months afterwards. Women who wish to breast feed are not eligible for the study. Adequate bone marrow function (White Blood Cell (WBC) > 3.4 x 109/L, platelets > 99 x 109/L) renal function (creatinine < 2.5 x the Upper Limit of Normal (ULN)) and hepatic function (Liver Function Test (LFT) < 1.5 x ULN) within 14 days prior to randomisation. Patients should have had surgery at least 4 weeks but no more than 3 months (91d) prior to treatment start date. Serum amylase < 1.5 x ULN Prothrombin or International Normalised Ratio (INR) and prothrombin time < 1.5 x ULN World Health Organisation (WHO) performance status 0 or 1. Written informed consent obtained.

•Prior anti-cancer treatment for renal cell carcinoma other than nephrectomy Cardiac arrhythmias requiring anti-arrhythmics (beta blockers and digoxin are allowed), symptomatic coronary artery disease or ischaemia, myocardial infarction within the last 6 months, congestive cardiac failure > (New York Heart Association (NYHA) class II. Active clinically serious bacterial or fungal infections. Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C. Pregnant or breast-feeding patients. Prior malignancy (except for cervical carcinoma in situ or adequately treated basal cell carcinoma). Concomitant medications which have adverse interactions with sorafenib: rifampin, grapefruit juice, ritonavir, ketoconazole, itraconazole and St John's Wort. Patients with uncontrolled hypertension.

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