Prospective Open-label Non-interventional, Non-controlled Multi Observational and Pharmaco-economic Phase IV Trial to Evaluate the Characteristics of Patients Treated for Advanced Renal Cell Carcinoma With Nexavar ® as Well as Effectiveness, Safety and Direct Medical Costs of Nexavar® Treatment Under Daily-life Treatment Conditions
18 Years
N/A
Both
Carcinoma, Renal Cell, Carcinoma, Renal Cell (Advanced)
Trial Information
Prospective Open-label Non-interventional, Non-controlled Multi Observational and Pharmaco-economic Phase IV Trial to Evaluate the Characteristics of Patients Treated for Advanced Renal Cell Carcinoma With Nexavar ® as Well as Effectiveness, Safety and Direct Medical Costs of Nexavar® Treatment Under Daily-life Treatment Conditions
Inclusion Criteria:
- Patients with diagnosis of advanced RCC and decision taken by the investigator to
prescribe Nexavar®. The patients should have sufficient knowledge of French or Dutch
to be able to participate in the Study
Exclusion Criteria:
- Exclusion criteria must be read in conjunction with the Belgian product information
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Proportion of patients who are progression-free at one year according to the RECIST criteria. The proportion of patients who are progression-free at 1, 3, 6 and 9 months will also be calculated
Outcome Time Frame:
At 1, 3, 6 and 9 months and after one year
Safety Issue:
No
Principal Investigator
Bayer Study Director
Investigator Role:
Study Director
Investigator Affiliation:
Bayer
Authority:
Belgium: Institutional Review Board
Study ID:
13102
NCT ID:
NCT00771147
Start Date:
June 2008
Completion Date:
November 2010
Related Keywords:
- Carcinoma, Renal Cell
- Carcinoma, Renal Cell (Advanced)
- Advanced Renal Cell Carcinoma ( RCC)
- Carcinoma
- Carcinoma, Renal Cell
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