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

Phase 2

• Conditions: Metastatic Renal Cell Carcinoma
• Interventions: Drug: sorafenib

• Registration Number: NCT01444807
• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief 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.

Study Timeline

• Study First Submitted: 2011-09-08
• Study First Submitted QC: 2011-09-30
• Study First Posted: 2011-10-03
• Study Start: 2011-12
• Primary Completion: 2017-03
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-16
• Last Update Posted: 2021-09-17
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sorafenib	sorafenib	Active Arm

Primary Outcome Measures

Name	Time	Method
Recurrence Free Survival	December 2011 - December 2014 (3 years)	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),

Secondary Outcome Measures

Name	Time	Method
Safety Profile	December 2011 - December 2014 (3 years)	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
Overall Survival	December 2011 - December 2014 (3 years)
Vascular endothelial growth factors (VEGF) levels in BSC and Sorafenib arm.	December 2011 - December 2014 (3 years)

Trial Locations

Locations (14)

Enrico Cortesi; 🇮🇹 Roma, Italy

Istituto Tumori Milano; 🇮🇹 Milan, Mi, Italy

Cinzia Ortega; 🇮🇹 Alba, Italy

Rodolfo Passalaqua; 🇮🇹 Cremona, Italy

Franco Morelli; 🇮🇹 San Giovanni Rotondo, Italy

Francesco Atzori; 🇮🇹 Cagliari, Italy

Francesco Cognetti; 🇮🇹 Roma, Italy

Francesco Di Costanzo; 🇮🇹 Firenze, Italy

Vincenzo Emanuele Chiuri; 🇮🇹 Lecce, Italy

Alessandra Bearz; 🇮🇹 Aviano, Italy

Saverio Cinieri; 🇮🇹 Brindisi, Italy

Alfredo Berruti; 🇮🇹 Brescia, Italy

Alessandra Mosca; 🇮🇹 Novara, Italy

Vittorio Gebbia; 🇮🇹 Palermo, Italy