CSP #2005: VA Lung Cancer Surgery or Stereotactic Radiotherapy (VALOR) - VA Cooperative Studies Program (CSP)
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VA Cooperative Studies Program (CSP)

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CSP #2005: VA Lung Cancer Surgery or Stereotactic Radiotherapy (VALOR)

 

Investigator Access

What's Available





Check with the study contact and publications for information on a public dataset, data archive, data enclave, or website where data might be available.

Available Documentation

Dates Data are Available

Access Criteria

Study Characteristics

Objectives

Patients with stage I non-small cell lung cancer (NSCLC) have been historically treated with surgery whenever they are fit for an operation. However, an alternative treatment known as stereotactic radiotherapy now appears to offer an equally effective alternative. Doctors believe both are good treatments and are therefore conducting this study to determine if one may be possibly better than the other.

Era of Service

All

Population

Any patient with a preliminary diagnosis of stage I NSCLC, whether pathologically proven by biopsy or highly suspicious by radiographic imaging, seeking treatment at the VA (participants will ultimately need biopsy confirmation before enrolling).

Study Design

Multisite, randomized clinical trial

Intervention

  • Experimental: Stereotactic radiotherapy
  • Active comparator: Surgery (standard lobectomy or limited anatomic pulmonary resection)

Time Period

2017 – present

Setting

National

N

Estimated 670 participants

Response Rate

Unconfirmed

Recruitment Method

The recruitment process includes shared decision making and multi-disciplinary evaluations with lung cancer specialists. Teams of specialists use lung tumor conferences and electronic alerts through radiology to identify all potential participants for discussion. Local research coordinators and site-PIs determine all referral pathways to identify new cases at their site.

Once a potential participant is identified the research coordinators and site-PI will approach the patient at the earliest referral to a lung cancer specialist. They will describe the study, offer the opportunity to watch an educational video, provide materials, and offer consent. Mandatory evaluations before randomization include tissue confirmation of NSCLC, staging with FDG-PET/CT, and biopsies of all hilar and/or mediastinal lymph nodes >10mm that have a SUV >2.5. Pre-randomization elective lymph node sampling is strongly encouraged, but not required. Following treatment, patients will be followed for a minimum of 5 years.

Compensation

Participants will be reimbursed $50 per visit that is not consistent with usual care, including scheduled annual follow-up visits to complete self-report surveys and pulmonary function tests (for a possible total of $250 for all 5 years of active follow-up).

Data Collected

Primary Outcome  

  • Overall Survival  

Secondary Outcomes

  • Patient reported health-related quality of life
  • Respiratory Symptoms 
  • Health State Utilities
  • Lung cancer mortality 
  • Tumor patterns of failure
  • Respiratory Function                     

Data Collection Methods

  • Questionnaires
  • Laboratory reports
  • Medical record review

Funding Source

VA Office of Research and Development (ORD)

Investigators

Study Co-Chair: Drew Moghanaki, MD, MPH
Study Co-Chair: David H. Harpole, MD

Contact

Study Project Manager: Tom Sindowski; Tom.Sindowski@va.gov
National Study Coordinator: Vicki Skinner, RN; Vicki.Skinner@va.gov

Selected Publications

Moghanaki D., Karas T. Surgery versus SABR for NSCLC. Lancet Oncol. 2013 Nov;14(12):e490-1. PMID: 24176566

More Information

Study ClinicalTrials.gov site
ClinicalTrials.gov Identifier: NCT02984761