Biological, Pathological and Imagery Markers in the First-line Treatment of Metastatic Clear-cell Renal Cell Carcinoma

Inclusion criteria :

* Patients with renal tumor in place, resectable, with at least one measurable metastasis 1.5 cm and indication of antiangiogenic therapy
* Histopathologically confirmed clear cell renal cell carcinoma (biopsy) and possibility of adequate tumor sampling prior to treatment
* No prior systemic treatment for RCC
* Male or female, 18 years
* Performance status ECOG 0-1
* Life expectancy 3 months
* Adequate organ function as defined by the following criteria:
* Total serum bilirubin 2 x ULN (Gilbert's disease exempt)
* Serum transaminases and alcalines phosphatases 2.5 x ULN, or in case of liver or bone metastasis 5x ULN

  * Serum creatinine 2 x ULN, creatinine clearance 80 ml/mn
  * Absolute neutrophil count (ANC) 1500/mm3
  * Platelets 100,000/mm3
  * Hemoglobin 10.0 g/dL
  * INR 1.7 or prothrobin time (PT) 6sec over
* Negative pregnancy test within 7 days prior to registration
* Signed and dated IRB/ICE-approved informed consent.
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
* Patient covered by the national health system

Exclusion criteria :

* Previous nephrectomy
* Renal sarcoma, papillary tumors or collecting duct carcinoma
* Treatment in a clinical trial in the last 30 days
* Previous treatment with Sunitinib or other antiangiogenics
* Any of the following within 12 months prior to treatment initiation: severe/unstable angina, myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, thrombo-embolic accident or cerebrovascular accident including transient ischemic attack.
* Uncontrolled hypertension defined as systolic blood pressure \>150mmHg or diastolic pressure \>90mmHg, despite optimal medical treatment
* Ongoing cardiac dysrhythmia of grade 2, atrial fibrillation of any grade, QTc interval \>0.50
* Treatment with anticoagulant agents and treatment with therapeutic doses of warfarin within 2 weeks prior to first day of Sunitinib. Low dose warfarin for deep vein thrombosis prophylaxis is permitted up to 2mg/day. Low molecular weight heparin or aspirin are allowed
* Any medical condition that might interfere with oral medication absorption
* Brain metastasis. Note: Brain scan or MRI is mandatory
* LVEF value \< 50%
* Prior radiation therapy.
* Pregnancy or breastfeeding. Women and men must agree to use effective contraception during the study period. Acceptable contraception includes implants, oral contraceptives, intrauterine devices, surgical sterilization.
* Any acute or chronic medical or psychiatric condition or laboratory abnormality that would make the patient inappropriate with this study.
* Any second malignancy within the last 5 years with the exception of basal cell carcinoma, cervical cancer in situ and pT1/a bladder cancer with no evidence of recurrent disease for 12 months.
* Hypersensitivity to the Sunitinib malate or any excipient of Sutent