ABOUT THIS STUDY
- 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
- 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
- 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
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