Patient Characteristics in Advanced Renal Cell Carcinoma and Daily Practice Treatment With Nexavar

Completed

• Conditions: Carcinoma, Renal Cell; Carcinoma, Renal Cell (Advanced)
• Interventions: Drug: Nexavar (Sorafenib, BAY43-9006)

• Registration Number: NCT00895674
• Lead Sponsor: Bayer

Brief Summary

Renal cell carcinoma accounts for roughly 3 % of all cancer. It is a rather aggressive cancer type, which means that patients who present with an advanced disease have a rather poor prognosis. When this study has been started the standard therapy for patients has been cytokines, which might be accompanied by significant toxicities or might fail the therapeutic goal. In these cases sorafenib can be a feasible therapeutic option. This non-interventional study has been created and is being conducted to collect clinical data on the patients' therapy with sorafenib in an everyday treatment schedule. The main goal of this study focuses on patient characteristics and tumor status in RCC treated with sorafenib as well as the treatment duration and safety of sorafenib under everyday treatment conditions.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2009-05-06
• Study First Submitted QC: 2009-05-07
• Study First Posted: 2009-05-08
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-29
• Last Update Posted: 2010-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2840

Inclusion Criteria

• Patients with diagnosis of advanced RCC and decision taken by the investigator to prescribe Sorafenib

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Exclusion Criteria

• Exclusion criteria must be read in conjunction with the local product information

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Nexavar (Sorafenib, BAY43-9006)	-

Primary Outcome Measures

Name	Time	Method
Tumor status	After about 3, 6, 9 and 12 months

Secondary Outcome Measures

Name	Time	Method
Treatment duration	At end of study after about 12 months
Safety of sorafenib treatment	At every documented visit for about 12 months
Progression-free survival	Calculation at end of study after about 12 months
Status of Metastases	After about 3, 6, 9 and 12 months
Performance status (ECOG)	After about 3, 6, 9 and 12 months