NCT01444807

Evaluate the Efficacy of Sorafenib in Renal Cell Carcinoma Patients After a Radical Resection of the Metastases

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the efficacy and tolerability of sorafenib in RCC patients underwent to metastasectomy

Detailed description

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.

Conditions

• Metastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	sorafenib	sorafenib 400 mg bid

Timeline

• Start date: 2011-12-01
• Primary completion: 2017-03-01
• Completion: 2022-03-01
• First posted: 2011-10-03
• Last updated: 2021-09-17

Locations

14 sites across 1 country: Italy