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Community Oncology Setting Disease Outcomes of Sorafenib (Nexavar) Use in Advanced Renal Cell Carcinoma

NCT ID: NCT00876382

Last Updated: 2013-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2011-08-31

Brief Summary

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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)

Detailed Description

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Recently, a number of targeted agents have demonstrated single-agent activity in the treatment of advanced renal cell carcinoma. Bevacizumab, a humanized monoclonal antibody directed against VEGF, resulted in an improvement in median progression-free survival when compared to placebo in a prospective, randomized trial. More recently, the multitargeted agents sorafenib and sunitinib have been approved for use in the treatment of advanced renal cell carcinoma. Both have proven superior to previous interferon and other standard treatment; however it is not clear how these drugs should be used in the treatment sequence. With roughly 80% of cancer patients receiving their oncology care in the community setting, we are proposing a review and evaluation of at least 200 advanced renal cell carcinoma patients.

Conditions

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Renal Cell Carcinoma

Keywords

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advanced renal cell carcinoma renal cancer renal cell Sorafenib Nexavar Bevacizumab Avastin Sunitinib Sutent

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey F Patton, M.D.

Role: STUDY_CHAIR

SCRI Development Innovations, LLC

Locations

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Northeast Arkansas Clinic

Jonesboro, Arkansas, United States

Site Status

Gulfcoast Oncology Associates

St. Petersburg, Florida, United States

Site Status

Medical Oncology Associates of Augusta

Augusta, Georgia, United States

Site Status

Consultants in Blood Disorders and Cancer

Louisville, Kentucky, United States

Site Status

Jackson Oncology Associates

Jackson, Mississippi, United States

Site Status

St. Louis Cancer Care

Chesterfield, Missouri, United States

Site Status

Oncology Hematology Care

Cincinnati, Ohio, United States

Site Status

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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SCRI OUTCOMES 06

Identifier Type: -

Identifier Source: org_study_id