EUCTR2006-006079-19-BE进行中（未招募）1 期
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 - SORCE
Medical Research Council Clinical Trial Unit0 个研究点目标入组 1,656 人开始时间: 2008年10月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,656
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Histologically proven RCC
- •2. No evidence of residual macroscopic disease on post-operative CT scan after
- •resection of RCC. Patients with clear cell or non-clear cell tumours are eligible
- •3. Patients with a pulmonary nodule may be eligible but the nodule needs to be
- •<5mm diameter and have been stable for at least 3 months (confirmed by CT
- •4. Patients with Intermediate” or High” risk per the Leibovich score 3 to 11
- •(Special pathology guidelines for Leibovich scoring of tumour samples see
- •appendix 1)
- •5. Subjects must be >18 years in age
- •6. 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 breast feed are not eligible for the
- •7. Adequate bone marrow function (WBC > 3.4x109/l, platelets > 99x109/l), renal
- •function (creatinine < 2.5 x upper limit of normal and hepatic function (LFT <1.5 x upper limit of normal) within 14 days prior to randomisation
- •8. Patients should have had surgery at least 4 weeks but no more than 3 months
- •(91 days) prior to treatment start date
- •9. Serum Amylase < 1.5 x upper limit of normal
- •10. Prothrombin (PT) or INR (International Normalized Ratio) and Prothrombin Time
- •(PTT) < 1.5 x upper limit of normal
- •11. WHO Performance Status 0 or 1 (Appendix 2)
- •12. Written Informed Consent obtained
- •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 1600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 56
排除标准
- •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 breast-feeding 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. Metastatic disease
- •8. Concomitant medications which have adverse interactions with sorafenib:
- •rifampin, ritonavir, ketoconazole, itraconazole and St John’s Wort.
- •9. Patients with uncontrolled hypertension
研究者
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