Phase II Stereotactic Body Radiotherapy for Stage I (T1-T2, N0, M0), Selective Stage II (Chest Wall T3, N0M0) or Isolated Peripheral Lung Recurrent Non-Small Cell Lung Cancer (NSCLC)
Stereotactic body radiotherapy is designed to provide an image guided, more focused, dose
escalated radiotherapy over a shorter time frame (1 week rather than 7 weeks) than
conventional radiation therapy. The goal of SBRT is to improve tumor control while reducing
the side effects.
If you are found to be eligible to take part in this study, you will receive daily SBRT for
4 days in a row over a 45 minute time period. During the treatment, you will lie still on a
table for about 45 minutes per day in the same position. The machine will deliver the dose
according to the plan developed by the doctor and the dose will be controlled by a computer.
During the treatment, you will be seen by a doctor and research nurse once a week to
evaluate possible side effects. A physical exam and a medical history will be done at these
You will be taken off study early if the disease gets worse or intolerable side effects
You will have a follow-up visit 6 weeks after completion of radiotherapy to check for side
effects. You will continue to have follow-up visits that will decrease in frequency over
time. You will have imaging tests (chest CT or PET scan) and routine blood tests (about 2
teaspoons) at these follow-up visits.
This is an investigational study. SBRT is FDA approved for the treatment of lung cancer.
About 138 patients will take part in this study. All will be enrolled at MD Anderson.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free Survival (PFS) at Treated Primary Tumor Site
Joe Y. Chang, MD, PhD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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