Evaluate the efficacy and tolerability of sorafenib in RCC patients underwent to metastasectomy
Advanced RCC presents poor prognosis, because its pathogenesis is not clearly understood. However, up-regulation of the Ras pathway is thought to play a role. VEGF expression could represent independent prognostic factors for survival possibly linking expression of this protein with clinical outcome. Sorafenib is a potent inhibitor of both Raf-kinase and VEGF R2 signalling The anti-tumoral activity of Sorafenib was clearly demonstrated in phase III trial regarding advanced pretreated RCC. Surgical removal of metastatic disease could potentially increase the disease control rate. Particularly in patients with a disease free interval post nephrectomy of at least 1 year, with one small metastatic lesion, metastasectomy could represents an important therapeutic approach. After a radical resection of the metastatic disease is unclear if an anti-tumoral systemic therapy may increase patient survival. In summary, both the preclinical and clinical data support further evaluation of Sorafenib in RCC patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
132
sorafenib 400 mg bid
Istituto Tumori Milano
Milan, Mi, Italy
Cinzia Ortega
Alba, Italy
Alessandra Bearz
Aviano, Italy
Alfredo Berruti
Recurrence Free Survival
Efficacy of Sorafenib compared with BSC, in RCC patients that have undergone radical resection of recurrent metastatic disease, after prior nephrectomy. The primary efficacy endpoint is Recurrence Free Survival (RFS),
Time frame: December 2011 - December 2014 (3 years)
Overall Survival
Time frame: December 2011 - December 2014 (3 years)
Safety Profile
Physical examination, vital signs, Red blood count: haemoglobin, hematocrit, platelet count, white blood cell count. WBC should include differential neutrophil, lymphocyte, monocyte, basophil and eosinophil counts. Electrolyte panel: sodium, potassium, chloride and corrected calcium.Chemistry panel: AST, ALT, bilirubin, alkaline phosphatase, uric acid, total protein, albumin, calcium, lipase, amylase, phosphate, LDH, glucose, creatinine,BUN, and bicarbonate. Coagulation panel: PT, PT-INR, PTT. Urinalysis, Adverse event
Time frame: December 2011 - December 2014 (3 years)
Vascular endothelial growth factors (VEGF) levels in BSC and Sorafenib arm.
Time frame: December 2011 - December 2014 (3 years)
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Brescia, Italy
Saverio Cinieri
Brindisi, Italy
Francesco Atzori
Cagliari, Italy
Rodolfo Passalaqua
Cremona, Italy
Francesco Di Costanzo
Florence, Italy
Vincenzo Emanuele Chiuri
Lecce, Italy
Alessandra Mosca
Novara, Italy
...and 4 more locations