This pilot clinical trial studies the effects of stereotactic body radiation therapy followed by surgery in treating patients with stage I-IIIA non-small cell lung cancer. Stereotactic body radiation therapy is a method of radiation that uses imaging to precisely locate a tumor and then deliver very high radiation doses to the tumor site in order to limit normal tissue toxicity or damage.
PRIMARY OBJECTIVES: I. To assess the safety and feasibility of combining single fraction stereotactic body radiation therapy (SBRT) followed by surgery, in thoracic malignancies. SECONDARY OBJECTIVES: I. To estimate overall survival (OS) and progression-free survival (PFS) after single fraction SBRT followed by surgery, in thoracic malignancies. II. To define any differences in quality of life/toxicity following SBRT based on tumor location/stage/tumor type. TERTIARY OBJECTIVES: I. To assess changes in T cell mediated immunity following SBRT in thoracic malignancies. OUTLINE: Patients are assigned to 1 of 3 studies. STUDY 1: Patients with stage I or II non-small cell lung cancer (NSCLC) in the peripheral lung undergo highest-dose of SBRT over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28. STUDY 2: Patients with stage I or II NSCLC in the central lung undergo lowest-dose of SBRT over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28. STUDY 3: Patients with stage IIIA NSCLC in the any lung location undergo lowest- or higher-dose of SBRT over a single treatment fraction on day 1. Patients then undergo thoracic surgery on day 28. After completion of study treatment, patients are followed up at 6, 9, and 12 months, every 6 months for 2 years, and then annually for 2 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Correlative studies
Ancillary studies
Undergo lowest-dose of SBRT
Undergo lowest- or higher-dose of SBRT
Undergo highest-dose of SBRT
Undergo thoracic surgery
Roswell Park Cancer Institute
Buffalo, New York, United States
Incidence of treatment-related grade 3-5 adverse events assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0
Comparison will be made with published historical and contemporaneous rates of toxicity with standard of care therapy for each of the study groups.
Time frame: Up to 10 weeks post-surgery
Overall survival
Will be measured and compared with published historical and contemporaneous rates of toxicity with standard of care therapy for each of the study groups.
Time frame: Up to 5 years
Progression free survival
Will be measured and compared with published historical and contemporaneous rates of toxicity with standard of care therapy for each of the study groups.
Time frame: Up to 5 years
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