Renal Cell Carcinoma MedDRA version: 21.1 Level: LLT Classification code 10038407 Term: Renal cell cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Nexavar
Product Name: Sorafenib
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
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 "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 =65 years) yes F.1.3.1 Number of subjects for this age range 855
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The standard treatment for patients with a kidney cancer which has not spread to other organs is to remove all or part of the diseased kidney (nephrectomy). The standard policy after this is watchful waiting. This means no treatment, but having regular checks so that if the cancer does come back it is caught early. The principal research question is whether sorafenib increases disease free survival (DFS) i.e reduces the risk of kidney cancer returning. SORCE aims to answer two questions. The first question is whether at least one year of treatment with sorafenib increases DFS compared with placebo. The second question is about the duration of sorafenib, and whether an additional 2 years of sorafenib (as given in Arm C) increases DFS compared to placebo.;Secondary Objective: The secondary research objectives are to assess renal cell carcinoma specific survival time, overall survival, cost effectiveness, toxicity, assessment of biological characteristics of the removed kidney tumour, and corroboration of Leibovich Prognostic score. ;Primary end point(s): The primary outcome measure is disease free survival (DFS) (i.e. time from randomisation to first evidence of local recurrence or distant metastases or death from RCC).;Timepoint(s) of evaluation of this end point: DFS will be assessed once the target number of control arm events have been accrued. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall Survival (OS) Metastasis-free Survival (MFS) RCC-specific Survival Time Toxicity Patient Reported Outcomes (PRO) ;Timepoint(s) of evaluation of this end point: The secondary endpoints will be assessed at the same time as the primary endpoints. | — |
Countries
Australia, Belgium, Denmark, France, Spain, United Kingdom
Contacts
Public ContactBen Smith
MRC Clinical Trials Unit at UCL
Outcome results
None listed