This clinical trial compares stereotactic ablative radiotherapy (SBRT) with hot spots to standard of care SBRT for the treatment of patients with early-stage non-small cell lung cancer. SBRT with hot spots intentionally makes sure the tumor gets a higher radiation dose during treatment. This potentially may result in better control of the tumor, but also more side effects. SBRT with or without hot spots may be more effective in treating patients with early-stage non-small cell lung cancer, compared to standard of care SBRT.
Age ≥ 18 years
Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Diagnosed with T1-3N0 biopsy-proven NSCLC of the lung. Multiple primary lung tumors are allowed; however, each lesion requires histologic confirmation
Metachronous lung tumors as defined as a new lung lesion in the setting of a historically treated lung cancer are allowed under certain conditions. The previous lung cancer must have been treated greater than 6 months prior to protocol therapy and this cancer must be considered controlled
Patients with a history of a prior lung cancer will be excluded only if the previous treatment is within 6 months of the protocol therapy
Mixed small cell and non-small cell lung cancer
History of allogeneic organ transplantation
History of primary immunodeficiency
Parallel
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Computed Tomography
Procedure/SurgeryUndergo CT scan
Lymph Node Biopsy
Procedure/SurgeryUndergo lymph node sampling
Positron Emission Tomography
Procedure/SurgeryUndergo PET scan
Stereotactic Body Radiation Therapy
RadiationReceive SOC SBRT
Stereotactic Body Radiation Therapy
RadiationReceive hot spot SBRT
Survey Administration
Other interventionAncillary studies
Time to progression (local control)
Defined as no failure within the radiotherapy planning target volume (PTV), based on the international consensus on assessing local failure after stereotactic ablative radiotherapy (SBRT) will be utilized. The 2-year local control rates will be summarized by treatment arms using 90% Clopper-Pearson confidence intervals. The local control rates between arms will be compared using one-sided Cochrane-Mantel-Haenszel test (alpha=0.1), stratified by performance status, surgery candidacy, and beta-blocker usage.
Progression free survival (PFS)
Will be summarized by treatment arms using the Kaplan-Meier product limit estimator.
Overall survival (OS)
Will be summarized by treatment arms using the Kaplan-Meier product limit estimator. One-sided log-rank test stratified by tumor size, performance status, and surgery candidacy will be used to compare the OS between treatment arms (alpha=0.1).
Time to progression (local control) in a size-dependent manner
Defined as no failure within the radiotherapy PTV, based on the international consensus on assessing local failure after SBRT will be utilized.
PFS for patients who are already taking a beta blocker
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