ABOUT THIS STUDY
- Patients must sign IRB/EC-approved informed consent.
- Age ≥ 18
- Histologically proven clear cell RCC (obtained by CT or US guided biopsy)
- cT2a N0NxM0 Renal tumor according to 2009 TNM classification (tumor Ø> 7cm; ≤ 10 cm)
- No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart.
- Normal renal function (MDRD creatinin clearance ≥ 60 ml/min)
- Patients must have adequate organ function defined as: Platelets ≥ 150 x 109/L, hemoglobin > 9 g/dl, absolute neutrophil count (ANC) >1.5 x 109/L; Bilirubin < 2 mg/dL, aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times the upper limit of normal; Total cholesterol ≤ 9.1 mmol/l and triglyceride level ≤ 4.5 mmol/l
- Urinary protein <2+ by urine dipstick.
- Patients with reproductive potential must use medically acceptable contraceptive method.
- Beneficiary of a social coverage (except AME)
- Patients with < 50 % clear cell histology
- Evidence of locally advanced disease: cT stage≥T2b, N Stage≥1 or metastatic disease
- Patients must not be pregnant or lactating.
- Patients must not have uncompensated coronary artery disease or an history of
myocardial infarction or severe or unstable angina within the past six months or
severe diabetes mellitus with severe arterial peripheral disease or deep venous or
arterial thrombosis or embolism with the past 3 months. Patients must not need
- Patients must not have any medical/systemic or psychiatric disorder incompatible with
- Patients must not have a history of significant gastric or small bowel resection,
malabsorption syndrome, or other lack of integrity of the upper gastrointestinal tract
that may compromise the absorption of Axitinib or an unavailability of the oral route.
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