Veterans Affairs Lung Cancer Or Stereotactic Radiotherapy (VALOR)

• Overall Survival [ Time Frame: From date of randomization through study completion, up to 10 years ]
  Survival estimates will include death from any cause.
  
  

• Patient reported health-related quality of life [ Time Frame: 5 years ]
  The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and Lung Cancer (LC 13) survey instruments will assess patients' general state of physical, social/family, emotional and functional well-being.
  
  
• Respiratory Symptoms [ Time Frame: 5 years ]
  The St George's Respiratory Questionnaire will evaluate respiratory symptoms, activity limitations from breathlessness, and impact of respiratory function on social and psychological functioning.
  
  
• Health State Utilities [ Time Frame: 5 years ]
  The EQ-5D-5L (EuroQOL-5D) survey will measure quality adjusted life years.
  
  
• Lung cancer mortality [ Time Frame: From date of randomization until date of death from any cause, assessed up to 10 years. ]
  Cause of death will be determined by an independent adjudication committee.
  
  
• Tumor patterns of failure [ Time Frame: 5 years ]
  Post-treatment surveillance imaging will evaluate patients every 6 months for local, regional, and/or distant disease control.
  
  
• Respiratory Function [ Time Frame: 5 years ]
  The Forced Expiratory Volume at 1 second (FEV1) will evaluate an objective measure of breathing function.
  
  

The standard of care for stage I non-small cell lung cancer has historically been surgical resection in patients who are medically fit to tolerate an operation. Recent data now suggests that stereotactic radiotherapy may be a suitable alternative. This includes the results from a pooled analysis of two incomplete phase III studies that reported a 15% overall survival advantage with stereotactic radiotherapy at 3 years. While these data are promising, the median follow-up period was short, the results underpowered, and the findings were in contradiction to multiple retrospective studies that demonstrate the outcomes with surgery are likely equal or superior. Therefore, the herein trial aims to evaluate these two treatments in a prospective randomized fashion with a goal to compare the overall survival beyond 5 years. It has been designed to enroll patients who have a long life-expectancy, and are fit enough to tolerate an anatomic pulmonary resection with intraoperative lymph node sampling.

This study is designed to open at Veterans Affairs medical centers with expertise in both treatments. The recruitment process includes shared decision making and multi-disciplinary evaluations with lung cancer specialists. 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.