Carcinoma, Renal Cell
Conditions
Keywords
Non-interventional, Nexavar, Sorafenib, Carcinoma, renal cell, Neoadjuvant, Nephrectomy, Russian Federation
Brief summary
This local, prospective, multicenter, non-interventional study documents observational data on patients under routine treatment of metastatic RCC with Nexavar before and after cytoreductive nephrectomy. It's planned to better understand the impact of cytoreductive nephrectomy on Nexavar efficacy and possibly to define patients who get the most benefit from Nexavar before cytoreductive nephrectomy.
Interventions
The patients under routine treatment of metastatic RCC with Nexavar before and after cytoreductive nephrectomy meeting the criteria of inclusion.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \- Male and female patients ≥ 18 years old * Patients with untreated metastatic RCC in whom a decision on neoadjuvant treatment with Nexavar before cytoreductive nephrectomy and in case of clinical feasibility resumption of treatment with Nexavar after nephrectomy has been made at the time of study enrollment * Life expectancy of at least 16 weeks * Patients should have signed informed consent form
Exclusion criteria
* Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer. * All contra-indications according to the Russian marketing authorization: * Hypersensitivity to sorafenib or to any of the excipients. * Pregnancy and breast-feeding. * Age less than 18 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum percent reduction (based on the minimum post baseline value) in the longest diameter of the primary tumor in response to neoadjuvant Nexavar treatment. | up to 2 years |
| Response rate of residual disease to Nexavar according to RECIST 1.1 with baseline after cytoreductive nephrectomy. | up to 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Maximum percent reduction in the sum of longest diameters of target lesions according to RECIST 1.1 while on Nexavar treatment before cytoreductive nephrectomy | up to 2 years |
| Response before cytoreductive nephrectomy according to RECIST 1.1. | up to 2 years |
| Maximum percent reduction in the sum of longest diameters of target lesions of residual disease after cytoreductive nephrectomy according to RECIST 1.1 while on Nexavar treatment with baseline after cytoreductive nephrectomy. | up to 2 years |
| Number of participants with AEs, including intra- and postoperative complications, relation to Nexavar treatment, AEs treatment, AEs outcome. | up to 2 years |
Countries
Russia
Outcome results
None listed