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VA Cooperative Studies Program (CSP)

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CSP #2005 Surgery or Stereotactic Radiotherapy for Early-Stage Lung Cancer






VALOR Recruitment Video (click on image; best viewed in Google Chrome Browser)

Overview

CSP #2005 study is a national voluntary research study that is sponsored by the VA’s Office of Research and Development. It is also known as VALOR, which stands for “Veterans Affairs Lung cancer surgery Or stereotactic Radiotherapy.” The goal of VALOR is to evaluate the role of stereotactic body radiation therapy (SBRT) for patients (participants) with early stage lung cancer who are usually treated with surgery.
 
Background
The standard of care for patients with early stage lung cancer is surgery. However, other options are being studied. This includes SBRT, that is typically used for patients who are too frail or unfit to undergo surgery.
 
It was recently discovered that patients who are being treated with SBRT are doing much better than expected. Therefore, doctors are curious whether SBRT may be just as good for patients who are typically treated with surgery. However, without a study like VALOR, healthcare professionals may never know if it is truly better, worse or the same as surgery. This is why VA has opened this trial—to learn the best way to treat early stage lung cancer.
 
Status of the Project
VALOR was opened to recruitment in April 2017. It is currently in a ramp-up phase, and open at nine VA medical centers. There are plans to expand the study to a total of about 20 VA medical centers in order to meet the goal of recruiting 670 patients.

 
Who Can Participate?
Veterans with early stage lung cancer can participate if they are evaluated by a VALOR study team at their local VA medical center. A determination must be made that they can receive either surgery or SBRT. They must also meet all of the study’s eligibility criteria. Those who agree to participate will be randomly assigned to receive either surgery or SBRT. Then they will be closely followed for a minimum of five (5) years.
 
Which VA Medical Centers are Recruiting Patients?
The study is currently recruiting patients at VA medical centers in Richmond, Minneapolis, Indianapolis, Durham, Houston, Bay Pines (FL), Long Beach (CA), Pittsburgh and Chicago (Hines).
 
Human Research Protections
The VALOR protocol has been approved by the VA Central Institutional Review Board (IRB), VA Cooperative Studies Scientific Evaluation Committee (CSSEC) and the U.S. Food and Drug Administration (FDA). Each of these groups is also constantly monitoring the activities of the study.
 
Leadership
The VALOR study's Co-Chairs are Drew Moghanaki, MD, MPH, who is Chief of Radiation Oncology at the Atlanta VA Medical Center, and David H. Harpole, Jr., MD, who is Chief of Cardiothoracic Surgery at the Durham VA Medical Center in North Carolina.
 
Sponsorship
This project is sponsored by the Department of Veterans Affairs’ Cooperative Studies Program (CSP).
 
For more information
If you have any questions, please contact VALOR National Coordinator Vicki Skinner, RN, MSN, at vicki.skinner@va.gov.


Updated April 2019

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