Evaluate the Efficacy of Sorafenib in Renal Cell Carcinoma Patients After a Radical Resection of the Metastases
Evaluate the efficacy and tolerability of sorafenib in RCC patients underwent to metastasectomy
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Open Label, Multicenter Phase 2 Study, to Evaluate the Efficacy of Sorafenib in Patients With Advanced Renal Cell Carcinoma (RCC) After a Radical Resection of the Metastases|
- Recurrence Free Survival [ Time Frame: December 2011 - December 2014 (3 years) ] [ Designated as safety issue: No ]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),
- Overall Survival [ Time Frame: December 2011 - December 2014 (3 years) ] [ Designated as safety issue: No ]
- Safety Profile [ Time Frame: December 2011 - December 2014 (3 years) ] [ Designated as safety issue: Yes ]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
- Vascular endothelial growth factors (VEGF) levels in BSC and Sorafenib arm. [ Time Frame: December 2011 - December 2014 (3 years) ] [ Designated as safety issue: No ]
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
sorafenib 400 mg bid
Other Name: Nexavar (Bayer Health Care - Leverkusen - Germany)
No Intervention: Best Supportive Care
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.
|Contact: Giuseppe Procopio, MDfirstname.lastname@example.org|
|Istituto Tumori Milano||Recruiting|
|Milan, Mi, Italy, 20156|
|Contact: Giuseppe Procopio, MD +390223902557 Giuseppe.Procopio@istitutotumori.mi.it|
|Contact: Elena Verzoni, MD +390223902557 email@example.com|
|Principal Investigator: Giuseppe Procopio, MD|
|Study Chair:||Giuseppe Procopio, MD||Istituto Tumori Milano|