VA Cooperative Studies Program (CSP)
CSP #2005 Surgery or Stereotactic Radiotherapy for Early-Stage Lung Cancer
VALOR recruitment video
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 SBRT 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 the active recruitment phase, and open at fifteen VA medical centers with 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 the study’s eligibility criteria and none of the ineligibility criteria. Those who agree to participate will be randomized to receive either surgery or SBRT. Participants are 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 Ann Arbor (MI), Baltimore (MD), Bay Pines (FL), Boston (MA), Cleveland (OH), Durham (NC), Hines (IL), Houston (TX), Indianapolis (IN), Long Beach (CA), Los Angeles (CA), Miami (FL), Milwaukee (WI), Minneapolis (MN), and Philadelphia (PA).
Human Research Protections
The VALOR protocol has been approved by the VA Central Institutional Review Board (IRB), VA Cooperative Studies Program Central Office (CSPCO) 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, a radiation oncologist at the Greater Los Angeles VA Medical Center, and David H. Harpole, Jr., MD, a thoracic surgeon 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.
Publications
- Moghanaki D, Karas T. Surgery versus SABR for NSCLC. Lancet Oncology 2013 https://doi.org/10.1016/S1470-2045(13)70445-5
- Moghanaki D, Karas T, Timmerman R, et al, Protocol for the Veterans Affairs Cooperative Studies Program Study Number 2005: A Phase 3 Randomized Trial of Lung Cancer Surgery or Stereotactic Radiotherapy for Operable Early-Stage Non-Small Cell Lung Cancer. CHEST Pulmonary 2023 Dec;1(3). https://doi.org/10.1016/j.chpulm.2023.100024
- Ritter T, Timmerman R, et al, Centralized Quality Assurance for Stereotactic Body Radiation Therapy Treatments Delivered in the Veterans Affairs Cooperative Studies Program Study #2005: A Phase III Randomized Trial of Lung Cancer Surgery or Stereotactic Radiotherapy for Operable Early-Stage Non-Small Cell Lung Cancer (VALOR). Practical Rad Oncology 2024 https://doi.org/10.1016/j.prro.2024.07.010
ClinicalTrials.gov
ClinicalTrials.gov: https://www.clinicaltrials.gov/study/NCT02984761
