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: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

-Histologically proven RCC(All cell types 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
-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).
-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)
-Subjects must be >18 years in age
-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
-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
- Patients should have had surgery at least 4 weeks but no more than 3 months
(91 days) prior to treatment start date
- Serum Amylase < 1.5 x upper limit of normal
-Prothrombin (PT) or INR (International Normalized Ratio) and Prothrombin Time
(PTT) < 1.5 x upper limit of normal
-WHO Performance Status 0 or 1 (Appendix 2)
-Written Informed Consent obtained

Exclusion Criteria

-Prior anti-cancer treatment for RCC other than nephrectomy
-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
-Active clinically serious bacterial or fungal infections
-Known history of human immunodeficiency virus (HIV) infection or chronic
hepatitis B or C
-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
-Prior malignancy (except for cervical carcinoma in situ or adequately treated
basal cell carcinoma)
-Concomitant medications which have adverse interactions with sorafenib:
rifampin, grapefruit juice, ritonavir, ketoconazole, itraconazole and St John*s
Wort.
-Patients with uncontrolled hypertension
-Patients with a pulmonary nodule *5 mm diameter or multiple
pulmonary nodules.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is disease free survival (DFS) (i.e. time from<br /><br>randomisation to first evidence of local recurrence or distant metastases or<br /><br>death<br /><br>from RCC).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome measures include RCC-specific survival time (i.e.<br /><br>time to death from RCC), overall survival (OS), cost effectiveness, toxicity,<br /><br>biological<br /><br>characteristics of resected primary RCC (VHL, VEGFR2, FGF2, B-RAF, MEK, ERK) and<br /><br>corroboration of Leibovich Prognostic Score.</p><br>

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