Lung Cancer Clinical Trial
Official title:
A Randomized Phase II Study Comparing 2 Stereotactic Body Radiation Therapy (SBRT) Schedules for Medically Inoperable Patients With Stage I Peripheral Non-Small Cell Lung Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized
radiation therapy that delivers a high dose of radiation directly to the tumor may kill more
tumor cells and cause less damage to normal tissue. It is not yet known which regimen of
stereotactic body radiation therapy is more effective in treating patients with non-small
cell lung cancer.
PURPOSE: This randomized phase II trial is studying the side effects of two radiation therapy
regimens and to see how well they work in treating patients with stage I non-small cell lung
cancer.
OBJECTIVES:
Primary
- To determine the 1-year rate of ≥ grade 3 adverse events that are definitely, probably,
or possibly related to treatment with single fraction vs multiple fraction stereotactic
body radiotherapy in medically inoperable patients with stage I peripheral non-small
cell lung cancer.
Secondary
- To estimate the 1-year primary tumor control rate in these patients.
- To estimate the 1-year overall survival and disease-free survival rate of these
patients.
- To assess FDG-PET (fluorodeoxyglucose - positron emission tomography) standardized
uptake value changes as a measure of treatment response and outcomes.
- To determine pulmonary function changes by treatment arm and response.
- To determine the association between biomarkers and primary tumor control and/or ≥ grade
2 radiation pneumonitis.
OUTLINE: This is a multicenter study. Patients are stratified according to Zubrod performance
status (0 vs 1 vs 2) and T stage (T1 vs T2). Patients are randomized to 1 of 2 treatment
arms.
After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 2 years, and then annually thereafter.
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