This phase II trial investigates how stereotactic radiosurgery affects brain functions while treating patients with small cell lung cancer that has spread to the brain (brain metastasis). Standard of care treatment consists of whole brain radiation therapy, which targets the entire brain, and may result in side effects affecting the nervous system. Stereotactic radiosurgery only targets areas of the brain that are suspected to be affected by the disease. The purpose of this trial is to learn if and how patients’ brain functions are affected by the use of stereotactic radiosurgery rather than whole brain radiation therapy in managing brain metastasis caused by small cell lung cancer. Stereotactic radiosurgery may help patients avoid nervous system side effects caused by whole brain radiation therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04516070.
PRIMARY OBJECTIVE:
I. To estimate the cognitive decline rate at 3 months.
SECONDARY OBJECTIVES:
I. To examine cognitive decline rate on each individual cognitive test at each time point.
II. To examine cognitive decline rates using reliable change index methodology.
III. To examine changes in MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT) and EuroQol 5-Dimension 5-Level (EQ-5D-5L) from baseline to each follow up time point.
IV. To report the overall survival of patients (death due to any cause) of patients receiving stereotactic radiosurgery (SRS) for small cell lung cancer (SCLC) brain metastasis.
V. To report rates of local tumor control (of the treated lesions) in the brain post-treatment, as dictated by magnetic resonance imaging (MRI) surveillance schedule above.
VI. To report distant tumor control in the brain (of non-treated lesions) post-treatment, as dictated by MRI surveillance schedule above.
VII. To report time elapsed from SRS to whole brain radiation therapy (WBRT).
VIII. To report rates of intracranial toxicity of concurrent atezolizumab with SRS.
IX. To determine rates of systemic and intracranial disease control (time to progression) in those who are treated concurrently with atezolizumab and SRS.
X. To determine the rates of SCLC-specific survival.
XI. To assess the pre-treatment factors and baseline characteristics in the predictive determination of local control, intracranial control, systemic control, and neurocognitive outcomes.
XII. To assess the correlation between number of lesions and total volume of intracranial disease and neurocognitive outcome.
XIII. To document post-treatment intracranial toxicity profile in patients after SRS.
CORRELATIVE OBJECTIVE:
I. Cerebral spinal fluid (CSF) biomarkers.
OUTLINE:
Patients undergo SRS in the absence of disease progression or unacceptable toxicity. Patients whose disease progresses may be treated with additional courses of SRS per physician discretion. Patients also undergo MRI throughout the trial and may undergo a lumbar puncture during screening and follow up. Patients may also undergo computed tomography (CT) or positron emission tomography (PET)/CT on study at the the discretion of the treating physician.
After completion of study treatment, patients are followed up at 1, 3, 6, 9, 12, 16, 20, 24, 30, and 36 months after SRS.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorJing Li
