Multicenter, Prospective, Non-interventional Study "Sorafenib as Neoadjuvant Therapy Before Cytoreductive Nephrectomy in Patients With Metastatic Renal Cell Carcinoma"

Bayer0 sites61 target enrollmentJanuary 10, 2014

ConditionsCarcinoma, Renal Cell

InterventionsSorafenib (Nexavar, BAY 43-9006)

DrugsSorafenib (Nexavar, BAY 43-9006)

Overview

Phase: Not Applicable
Intervention: Sorafenib (Nexavar, BAY 43-9006)
Conditions: Carcinoma, Renal Cell
Sponsor: Bayer
Enrollment: 61
Primary Endpoint: Maximum percent reduction (based on the minimum post baseline value) in the longest diameter of the primary tumor in response to neoadjuvant Nexavar treatment.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 10, 2014

End Date

December 7, 2017

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Group 1

Intervention: Sorafenib (Nexavar, BAY 43-9006)

Outcomes

Primary Outcomes

Maximum percent reduction (based on the minimum post baseline value) in the longest diameter of the primary tumor in response to neoadjuvant Nexavar treatment.

Time Frame: up to 2 years

Response rate of residual disease to Nexavar according to RECIST 1.1 with baseline after cytoreductive nephrectomy.

Time Frame: up to 2 years

Secondary Outcomes

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)
Response before cytoreductive nephrectomy according to RECIST 1.1.(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)
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)