Carcinoma, Renal Cell
Conditions
Keywords
renal cell carcinoma, first targeted therapy, observational study
Brief summary
This is an observational study which will investigate the use of Nexavar as first targeted therapy in patients with advanced renal cell carcinoma.
Interventions
Dosage according to label or at discretion of the attending physician
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with a diagnosis of advanced Renal cell carcinoma (RCC) for whom the decision has been taken by the investigator to prescribe Nexavar. * Patients who failed cytokine therapy or who are not suitable for cytokines for whom Nexavar is the first targeted drug treatment.
Exclusion criteria
* Prior targeted therapy for RCC * Contraindications of Nexavar described in the Summary of Product Characteristics (SPC).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of Nexavar treatment | up to 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | 1 - 1.5 years after LPLV |
| Health related quality of life (HRQoL) | up to 3 years |
| Progression-free survival (PFS) | up to 3 years |
| Tumor status, of patients will be evaluated according to the categories Complete Response, Partial Response, Stable Disease, Clinical Progression, Radiological Progression. | up to 3 years |
| Incidence of Treatment-emergent Adverse Events (TEAE) | up to 3 years |
Countries
Germany
Outcome results
None listed