Renal Cell Carcinoma Clinical Trial
Official title:
Community Oncology Setting Disease Outcomes of Sorafenib (Nexavar) Use in Advanced Renal Cell Carcinoma
A retrospective medical record abstraction study of at least 200 advanced renal cell
carcinoma patients treated in the following settings:
- Patients with advanced renal cell carcinoma treated with Sorafenib (Nexavar) as
second-line therapy after Sunitinib (Sutent) or Bevacizumab (Avastin) for first-line
therapy (about 100 patients)
- Patients with advanced renal cell carcinoma treated with Sorafenib (Nexavar) as
first-line therapy followed by Sunitinib (Sutent) as second-line therapy (about 100
patients)
Status | Completed |
Enrollment | 47 |
Est. completion date | August 2011 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Eligible patient cases are those that have received Sorafenib (Nexavar) as second-line therapy after Sunitinib (Sutent) or Bevacizumab (Avastin) for first-line therapy or those patients that were treated with Sorafenib (Nexavar) as first-line therapy followed by Sunitinib (Sutent) as secondline therapy. |
Observational Model: Case-Only, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
United States | Medical Oncology Associates of Augusta | Augusta | Georgia |
United States | St. Louis Cancer Care | Chesterfield | Missouri |
United States | Oncology Hematology Care | Cincinnati | Ohio |
United States | Jackson Oncology Associates | Jackson | Mississippi |
United States | Northeast Arkansas Clinic | Jonesboro | Arkansas |
United States | Consultants in Blood Disorders and Cancer | Louisville | Kentucky |
United States | Tennessee Oncology, PLLC | Nashville | Tennessee |
United States | Gulfcoast Oncology Associates | St. Petersburg | Florida |
Lead Sponsor | Collaborator |
---|---|
SCRI Development Innovations, LLC | Bayer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the safety and efficacy of Nexavar as second-line therapy in patients with advanced renal cell carcinoma treated with Nexavar after first-line therapy with Sutent or Avastin. | 6 months | No | |
Secondary | To evaluate safety and efficacy of Nexavar as first-line therapy in patients with advanced renal cell carcinoma and as first-line therapy followed by Sutent as second-line therapy in patients with advanced renal cell carcinoma. | 6 months | No |
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