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: 1711

Inclusion Criteria

1.Histologically proven RCC (all celltypes of RCC are eligible, except pure oncocytoma as distinct from an RCC with oncocytic features). 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
2. Patients with a pulonary nodule may be eligle but the nodule needs to be <5 mm diameter and have been stable for at least 3 months
3. Patients with Intermediate or High risk per the Leibovich score 3 to 11
4.Subjects must be >18 years in age without any other medical condition expected to reduce their life expectancy below 10 years from the time of study entry
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 breast feed are not eligible for the study
6. 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
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 INR (International Normalized Ratio) and Prothrombin Time (PTT) < 1.5 x upper limit of normal
10.WHO Performance Status 0 or 1
11. 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Prior anti-cancer treatment other than nephrectomy
2.Suspected allergy to sorafenib
3.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
4.Active clinically serious bacterial or fungal infections
5.Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
6.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
7.Prior malignancy (except for cervical carcinoma in situ or adequately treated basal cell carcinoma)
8.Concomitant medications which have adverse interactions with sorafenib: rifampin, grapefruit juice, 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

Related Trials

Phase 1

Medical Research Council Clinical Trial Unit

Updated 9/15/2020