SORCE: 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 Council (UK)0 个研究点目标入组 1,711 人开始时间: 2007年8月30日最近更新: 2021年4月19日

适应症

试验速览

•1. Histologically proven Renal Cell Carcinoma (RCC)
•2. No evidence of residual macroscopic disease on post-operative Computed Tomography (CT) scan after resection of RCC. Patients with clear cell or non-clear cell tumours are eligible
•3. Patients with 'Intermediate' or 'High' risk per the Leibovich score 3 to 11
•4. Subjects must be >18 years of age
•5. Women of childbearing age must have a negative pregnancy test and must use adequate contraception during the treatment phase of the study and for 9 months afterwards. Women who wish to breastfeed are not eligible for the study
•6. Adequate bone marrow function (White Blood Cells > 3.4x109/l, platelets > 99x109/l), renal function (creatinine < 2.5 x upper limit of normal and hepatic function (liver function test [LFT] < 1.5 x upper limit of normal) within 14 days prior to randomisation
•7. Patients should have had surgery at least 4 weeks but no more than 3 months prior to treatment start date
•8. Serum amylase < 1.5 x upper limit of normal
•9. ProThrombin (PT) or International Normalized Ratio (INR) and ProThrombin Time (PTT) < 1.5 x upper limit of normal
•10. World Health Organization Performance Status 0 or 1
•11. Written Informed Consent obtained

•1. Prior anti-cancer treatment for RCC other than nephrectomy
•2. 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 > NYHA Class II
•3. Active clinically serious bacterial or fungal infections
•4. Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
•5. Pregnant or breastfeeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug. Both men and women enrolled in this trial must use adequate birth control
•6. Prior malignancy (except for cervical carcinoma in situ or adequately treated basal cell carcinoma)
•7. Concomitant medications which have adverse interactions with sorafenib: rifampin, grapefruit juice, ritonavir, ketoconazole, itraconazole and St John's Wort
•8. Patients with uncontrolled hypertension

发起方

Medical Research Council (UK)