ABOUT THIS STUDY
- Men or women over 18 years old
- Patients with local, advanced or inoperable or metastatic (MRCC) renal cell carcinoma who are starting first line treatment with Sunitinib 50mg (4/6 regimen) according to the Marketing Authorisation Indication
- Patients with histologically or cytologically confirmed renal cancer, clear cell variant or with a clear cell component
- Karnofsky performance status ≥ 70%
- Adequate organ function:
- Absolute neutrophil (N) count ≥ 1 500 / µL
- Platelets ≥ 100 000 / µL
- Haemoglobin ≥ 10 g/dL
- Adjusted serum calcium ≤ 2.6 mmol/L
- Creatinine clearance ≥ 30 mL/min (by the MDRD formula)
- Total bilirubin ≤ 1.5 x ULN (upper limit of the normal range)
- AST ≤ 2.5 x ULN and ALT ≤ 2.5 x ULN OR AST and ALT ≤ 5 x ULN if liver abnormalities due to liver metastases AST = aspartate aminotransferase ALT = alanine aminotransferase
- Renal carcinoma with no clear cell component.
- Previous systemic treatment for the RCC regardless of type (including targeted
therapy, immunotherapy, chemotherapy, hormone or experimental therapy). Previous or
concomitant treatment with a bisphosphonate or denosumab is allowed.
- Patients whose clinical state and comorbidities are not consistent with administration
of Sunitinib at the initial dose of 50mg/day 4 weeks out of 6.
- Grade 3 haemorrhage within 4 weeks before starting treatment with Sunitinib (according
to the NCI-CTCAE toxicity score version 3.0).
- The presence of a past history of cancer in the 3 years before inclusion into the
- Major surgery within 4 weeks before sunitinib initiation
- Past history of symptomatic cerebral metastases, spinal cord compression or meningeal
carcinomatosis. Patients with cerebral metastases discovered incidentally on imaging
and who are asymptomatic are not excluded if these metastases have been treated
(radiotherapy and/or surgery) with a period of at least 4 weeks between the end of
treatment and inclusion into the study and no clinical or radiological signs of
relapse, and corticosteroid dose is not exceeding 10mg/day of prednisone or
equivalent. Subjects will be excluded if subjects have signs of grade ≥ 2
- Any of the following features within 6 months of the administration of Sunitinib:
myocardial infarction, severe/unstable angina, coronary artery/peripheral artery
bypass graft, symptomatic congestive heart failure, cerebrovascular accident or
transient ischemic attack.
- Pulmonary embolism or deep vein thrombosis within 3 months of inclusion (unless it's
stable, asymptomatic and treated with a low molecular weight heparin for at least 6
weeks before inclusion).
- Any known acute or chronic disorder (such as severe chronic obstructive pulmonary
disease) which in the opinion of the investigator could impact on the patient's
capacity to receive the study treatment or make interpretation of toxicity or adverse
- Known HIV infection.
- History of chronic active hepatitis including subjects who are carriers of the
hepatitis B (HBV) or hepatitis C (HCV) virus.
- Existence of uncontrolled infection.
- Uncontrolled hypertension defined as a blood pressure of > 150 mmHg systolic or > 100
mmHg diastolic despite optimal anti-hypertensive therapy (blood pressure must be
controlled at inclusion).
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- Besancon, Franche-Comté