The development of stereotactic body radiation therapy (SBRT) for the treatment of stage I non-small cell lung cancer (NSCLC) has inspired a close partnership between thoracic surgery and radiation oncology. In this study, patients with stage I NSCLC will be screened prior to treatment and will be consented after their treatment plan has been determined. Prospectively collected patient-reported outcomes (PROs) will be collected for 3 years or for the duration of the study (whichever is shorter), as will outcomes data.
Study Type
OBSERVATIONAL
Enrollment
446
Emory University
Atlanta, Georgia, United States
Carle Cancer Institute
Urbana, Illinois, United States
Washington University School of Medicine
St Louis, Missouri, United States
Memorial Sloan Kettering
New York, New York, United States
Duke University
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Toronto
Toronto, Ontario, Canada
Disease-free survival (DFS)
DFS is defined as time from the date of treatment to date of disease recurrence or death, whichever occurs earlier.
Time frame: Through 36 months post-treatment (estimated to be 36 months and 1 week)
Change in patient-reported outcomes as measured by the PROMIS Bank survey
* Surveys will occur at baseline, 1 month post-treatment, 6 months post-treatment, 12 months post-treatment, 24 months post-treatment, and 36 months post-treatment * The PROMIS scores will be compared across the 8 pre-specified domains: * Cancer Bank v1.1 - Physical Function * Cancer Bank v1.1 - Pain Interference * Cancer Bank v1.0 - Fatigue * Cancer Bank v1.0 - Depression * Cancer Bank v1.0 - Anxiety * Bank v1.0 - Dyspnea Severity * Bank v2.0 - Ability to Participate in Social Roles and Activities * Bank v2.0 - Cognitive Function * PROMIS is scored 1-100 and normalizes to the population mean of 50 with each 10 being a standard deviation. A higher score indicates a worse patient-reported outcome.
Time frame: From baseline through 36 months post-treatment (estimated to be 36 months and 1 week)
Cancer-specific survival (CSS)
Cancer-specific survival (CSS) is defined as time from the date of treatment to date of cancer-related death. The alive patients without any signs or symptoms of that cancer are censored at the last follow-up.
Time frame: Through 36 months post-treatment (estimated to be 36 months and 1 week)
Overall survival (OS)
Overall survival (OS) is defined as time from the date of treatment to date of death. The alive patients are censored at the last follow-up.
Time frame: Through 36 months post-treatment (estimated to be 36 months and 1 week)
Treated-related mortality
Time frame: At 30 days (estimated to be 1 month and 1 week)
Number of post-treatment events (grade 3 and above)
Post-treatment grade 3-5 events measured via CTCAE version 5.0
Time frame: Through 36 months post-treatment (estimated to be 36 months and 1 week)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.