Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Metastatic Lung Small Cell Carcinoma
  • Metastatic Malignant Neoplasm in the Brain
  • Stage IV Lung Cancer AJCC v8
  • Stage IVA Lung Cancer AJCC v8
  • Stage IVB Lung Cancer AJCC v8
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

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 report the overall surviv...

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 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. IV. 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. V. To report distant tumor control in the brain (of non-treated lesions) post-treatment, as dictated by MRI surveillance schedule above. VI. To report time elapsed from SRS to whole brain radiation therapy (WBRT). VII. To report rate of intracranial toxicity of SRS in the setting of prior 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. After completion of study treatment, patients are followed up at 1, 3, 6, 9, 12, 16, 20, 24, 30, and 36 months after SRS.

Tracking Information

NCT #
NCT04516070
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jing Li M.D. Anderson Cancer Center