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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1656

Inclusion Criteria

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
scan).
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
study
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

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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