This trial studies the side effects of single fraction stereotactic body radiation therapy after surgery in treating patients with non-small cell lung cancer. Standard radiation for lung cancer involves delivering small doses of daily radiation for several weeks. However, this technique has resulted in inferior outcomes compared to surgery and is associated with damage to surrounding normal lung. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. Giving stereotactic body radiation therapy in fewer treatment sessions (single fraction) may kill tumor cells and cause less damage to normal tissue.
PRIMARY OBJECTIVES: I. Assess feasibility and toxicity of single-fraction stereotactic body radiation therapy (SBRT) in the post-operative setting. SECONDARY OBJECTIVES: I. Assess quality of life following post-operative single-fraction SBRT. II. Assess rate of in-field failures. TERTIARY OBJECTIVES: I. Assess progression free survival and overall survival following post-operative SBRT for stage III/IV non-small cell lung cancer (NSCLC). EXPLORATORY OBJECTIVES: I. Changes in the inflammatory markers. OUTLINE: Beginning at least 2 weeks after surgical resection, patients undergo 1 fraction (or 5 fractions every other day if R2 resection of central tumor) of SBRT. After completion of study treatment, patients are followed up at 5 and 12 weeks and then periodically for up to 5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Roswell Park Cancer Institute
Buffalo, New York, United States
Incidence of grade 3 or greater toxicities
Hospitalization resulting from radiation treatment will be recorded. Any acute (=\< 180 days after the end of radiation therapy \[RT\]) and late (\> 180 days after the end of RT) toxicities will be documented using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicity rates will be presented with Clopper-Pearson 90% confidence intervals (alpha = 0.10).
Time frame: Up to 5 years
Feasibility of single fraction SBRT
Feasibility will be assessed by the median time to initiation of systemic treatment (TST) following the combination of surgery and stereotactic body radiation therapy (SBRT), as this interval will reflect the probability of completing intended treatment.
Time frame: Up to 5 years
Time to initiation of systemic treatment (TST)
The proportion of patients who have TST \< 8 weeks will be recorded. The median time will be presented with a 90% confidence interval (CI).
Time frame: From the date of surgery until the date of systemic treatment initiation, assessed up to 5 years
Quality of life (QoL)
The QoL scores, from European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EORTC QLQ Lung Cancer?Specific Module, and cumulative toxicity rates will be compared be at each time-point (starting 5 weeks after SBRT) between tumor locations using the Mann-Whitney U and Fishers exact tests, respectively. Comparisons of QoL scores between time-points will be made using the Wilcoxon signed rank test. All secondary analysis will be conducted at the 10% significance level. The QoL scores will also be examined for time trends and effects of patient characteristics using regression analysis.
Time frame: Up to 5 years
In-field failure (IFF) rate
IFF rate will be reported for the total cohort and at 3- and 5-years. The IFF will be monitored using a Bayesian approach. The monitoring will start after 3 patients have received treatment.
Time frame: Up to 5 years
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