A single-center controlled pilot study to investigate pre- and perioperative therapy with Sorafenib (Nexavar®) in patients who are candidates for a curative surgery of renal cell cancer (PREST = preoperative Sorafenib Therapy in RCC) - PREST

niversity Clinic of Heidelberg0 个研究点目标入组 40 人开始时间: 2008年7月9日最近更新: 2020年12月7日

试验速览

暂无简介。

•Patients with stage I / II or III renal cell carcinoma who are eligible for curative standard surgery of the primary tumor without any prior treatment at or immediately after primary diagnosis
•At least 18 years of age
•Sufficient bone marrow function: neutrophils > 1500/µl, hemoglobin >10 g/dl, and platelets > 100x109/l
•Patients with performance status of ECOG = 1
•AST and ALT = 2.5 x ULN (= 5 x ULN for patients with liver involvement of their cancer), total bilirubin = 1.5 x ULN; alkaline phosphatase = 4 x ULN, PT-INR/PT < 1.5 x ULN
•Serum creatinine = 1.5 x ULN; MDRD (GFR = 186 × (Serum-Creatinin[mg/dl]) -1.154 × (age) -0.203 × 0.742 (female patients) ) >/= 40 ml
•Ability of subject to understand character and individual consequences of the clinical trial
•Given written informed consent with the federal and institutional guidelines before any study treatment
•Life expectancy of at least 12 weeks
•Women and men with reproductive potential enrolled in this trial must use safe and effective barrier birth control measures during the course of the trial and for at least three months after the last administration of Sorafenib
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•History of cardiac disease: congestive heart failure (NYHA II-IV), active CAD (MI more than 6 months prior to study entry is allowed), cardiac arrhythmias requiring antiarrhythmic therapy (betablockers or digoxin are permitted) or uncontrolled hypertension
•History of wound healing complications
•History of HIV infection or chronic hepatitis B or C
•Active clinically serious infections (> Grade 2 NCI-CTC version 3.0)
•Symptomatic brain metastasis or meningeal tumors
•Pregnant or brest feeding women
•Patients with seizure disorders requiring medication (such as steroids or antiepileptics)
•History of organ allograft
•Patients with evidence or history of bleeding diathesis
•Patients undergoing renal dialysis
•Known or suspected allergy or hypersensitivity to the investigational agent or to any excipient present in the pharmaceutical form or any agent given in association with this trial
•Excluded therapies and medications, previous and concommitant
•Prior systemic therapy for RCC
•Prior surgery for RCC (RCC resection as part of study permitted). Major other surgery within 4 weeks prior to start of study or incomplete wound healing from previous other major surgery.
•Radiotherapy during study or within 3 weeks of start of study drug
•Enrollment in another clinical trial within the last 4 weeks
•Severe renal impairment that does not allow MR Contrast agents (glomerular filtration rate <30 mL/min/1.73m2)

发起方

niversity Clinic of Heidelberg