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Phase III Trial of Post-Surgical Stereotactic Radiosurgery (SRS) Compared with Whole Brain Radiotherapy (WBRT) for Resected Metastatic Brain Disease

1. Overall Survival To determine in patients with one to four brain metastases whether there is improved overall survival in patients who receive SRS to the surgical bed compared to patients who receive WBRT. 2. Neurocognitive Progression To determine in patients with one to four brain metastases whether there is less neurocognitive progression at 6 months post-randomization in patients who receive SRS to the surgical bed compared to patients who receive WBRT. Secondary Goals 1. Quality of Life (QOL) To determine in patients with resected brain metastases whether there is improved QOL in patients who receive SRS to the surgical bed compared to patients who receive WBRT. 2. Central Nervous System Failure To determine in patients with one to four brain metastases whether there is equal or longer time to central nervous system (CNS) failure (brain) in patients who receive SRS to the surgical bed compared to patients who receive WBRT. 3. Functional Independence To determine in patients with one to four brain metastases whether there is longer duration of functional independence in patients who receive SRS to the surgical bed compared to patients who receive WBRT. 4. Long-Term Neurocognitive Status To determine in patients with one to four brain metastases whether there is better long-term neurocognitive status in patients who receive SRS to the surgical bed compared to patients who receive WBRT. 5. Adverse Events To tabulate and descriptively compare the post-treatment adverse events associated with the interventions. 6. Local Tumor Bed Recurrence To evaluate local tumor bed recurrence at 6 months with post-surgical SRS to the surgical bed in comparison to WBRT. 7. Local Recurrence To evaluate time to local recurrence with post-surgical SRS to the surgical bed in comparison to WBRT. 8. CNS Failure Patterns To evaluate if there is any difference in CNS failure patterns (local, distant, leptomeningeal) in patients who receive SRS to the surgical bed compared to patients who receive WBRT. Correlative 1. Changes in the Limbic System To evaluate radiation changes in the limbic system that may correlate with neurotoxicity using brain MRI or CT scans. 2. ApoE Subtype To determine if Apo E (i.e., Apo E2, Apo E3 and Apo E4) genotyping may prove to be a predictor of radiation induced neurocognitive decline (or neuroprotection). 3. Inflammatory Markers To determine if inflammatory markers (i.e., IL-1, IL-6 and TNF-) may prove to be predictors of radiation induced neurocognitive decline. 4. Oxidative Stress Biomarkers To determine if oxidative stress biomarkers (i.e., protein carbonyl content, lipid hydroperoxides and isoprostane levels) may prove to be predictors of radiation induced neurocognitive decline. 5. Hormone and Growth Factors To determine if hormone and growth factors [i.e., glucocorticoids (i.e. cortisol), gonadal steroids (i.e., estradiol, testosterone, progesterone), growth hormone, human chorionic gonadotropin (hCG), insulin-like growth factor-1 (IGF-1) and neuronal growth factor (NGF)] may prove to be a predictor of radiation induced neurocognitive decline.

1. Overall Survival To determine in patients with one to four brain metastases whether there is improved overall survival in patients who receive SRS to the surgical bed compared to patients who receive WBRT. 2. Neurocognitive Progression To determine in patients with one to four brain metastases whether there is less neurocognitive progression at 6 months post-randomization in patients who receive SRS to the surgical bed compared to patients who receive WBRT. Secondary Goals 1. Quality of Life (QOL) To determine in patients with resected brain metastases whether there is improved QOL in patients who receive SRS to the surgical bed compared to patients who receive WBRT. 2. Central Nervous System Failure To determine in patients with one to four brain metastases whether there is equal or longer time to central nervous system (CNS) failure (brain) in patients who receive SRS to the surgical bed compared to patients who receive WBRT. 3. Functional Independence To determine in patients with one to four brain metastases whether there is longer duration of functional independence in patients who receive SRS to the surgical bed compared to patients who receive WBRT. 4. Long-Term Neurocognitive Status To determine in patients with one to four brain metastases whether there is better long-term neurocognitive status in patients who receive SRS to the surgical bed compared to patients who receive WBRT. 5. Adverse Events To tabulate and descriptively compare the post-treatment adverse events associated with the interventions. 6. Local Tumor Bed Recurrence To evaluate local tumor bed recurrence at 6 months with post-surgical SRS to the surgical bed in comparison to WBRT. 7. Local Recurrence To evaluate time to local recurrence with post-surgical SRS to the surgical bed in comparison to WBRT. 8. CNS Failure Patterns To evaluate if there is any difference in CNS failure patterns (local, distant, leptomeningeal) in patients who receive SRS to the surgical bed compared to patients who receive WBRT. Correlative 1. Changes in the Limbic System To evaluate radiation changes in the limbic system that may correlate with neurotoxicity using brain MRI or CT scans. 2. ApoE Subtype To determine if Apo E (i.e., Apo E2, Apo E3 and Apo E4) genotyping may prove to be a predictor of radiation induced neurocognitive decline (or neuroprotection). 3. Inflammatory Markers To determine if inflammatory markers (i.e., IL-1, IL-6 and TNF-) may prove to be predictors of radiation induced neurocognitive decline. 4. Oxidative Stress Biomarkers To determine if oxidative stress biomarkers (i.e., protein carbonyl content, lipid hydroperoxides and isoprostane levels) may prove to be predictors of radiation induced neurocognitive decline. 5. Hormone and Growth Factors To determine if hormone and growth factors [i.e., glucocorticoids (i.e. cortisol), gonadal steroids (i.e., estradiol, testosterone, progesterone), growth hormone, human chorionic gonadotropin (hCG), insulin-like growth factor-1 (IGF-1) and neuronal growth factor (NGF)] may prove to be a predictor of radiation induced neurocognitive decline.