Inclusion Criteria:

1. Nephrectomized, metastatic Clear Cell RCC patients not suitable for cytokines or
anti-angiogenesis (bevacizumab or sunitinib) therapy as first line treatment

2. Age ≥ 65years

3. ECOG Performance Status of ≤ 2

4. MSKCC prognostic score, good or intermediate

5. Life expectancy of at least 12 weeks.

6. Subjects with at least one uni-dimensional (for RECIST) measurable lesion. Lesions
must be measured by CT/MRI-scan.

7. Adequate bone marrow, liver and renal function as assessed by the following
laboratory requirements to be conducted within 7 days prior to start of therapy:

- Hemoglobin > 9.0 g/dl

- Absolute neutrophil count (ANC) ≥ 1,500/mm3

- Platelet count ≥ 100,000/μl

- Total bilirubin ≤ 1.5 times the upper limit of normal

- ALT and AST ≤ 2.5 x upper limit of normal (≤ 5 x upper limit of normal for
patients with liver involvement of their cancer)

- Alkaline phosphatase ≤ 4 x upper limit of normal

- PT-INR/PT ≤ 1.5 x upper limit of normal [Patients who are being therapeutically
anticoagulated with an agent such as coumadin or heparin will be allowed to
participate provided that no prior evidence of underlying abnormality in these
parameters exists.]

- Serum creatinine ≤ 1.5 x upper limit of normal.

8. Ability to take correctly oral drugs.

9. Absence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule;
those conditions should be discussed with the patient before registration in the
trial.

10. Written Informed Consent

11. To be able to understand medical instruction and to fill in the patient's diary. If
not, check if adequately supported by his/her family.

Exclusion Criteria:

1. Previous first line treatment for mRCC. No adjuvant or neoadjuvant treatments are
allowed.

2. Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6 months
from definitive therapy, has a negative imaging study within 4 weeks of study entry
and is clinically stable with respect to the tumor at the time of study entry)

3. History of cardiac disease: congestive heart failure >NYHA class 2; active CAD (MI
more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring
antiarrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled
hypertension.

4. History of previous or present seizure disorder requiring medication (such as
steroids or anti-epileptics), organ allograft, HIV infection or chronic hepatitis B
or C

5. Active clinically serious infections (≥ grade 2 NCI-CTC version 3.0)

6. Patients undergoing renal dialysis

7. Previous or concurrent cancer that is distinct in primary site or histology from the
cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal
cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively
treated > 3 years prior to study entry.

8. Patients with evidence or history of bleeding diathesis

9. Substance abuse, medical, psychological or social conditions that may interfere with
the patient's participation in the study or evaluation of the study results

10. Any condition that is unstable or could jeopardize the safety of the patient and
their compliance in the study

11. Known allergy to sorafenib or one of its constituents