Phase II Single-arm Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases.
- To estimate the rate of recurrence at the surgical site in patients with brain
metastases treated with neoadjuvant stereotactic radiosurgery (SRS) compared with
historical data documenting recurrence at the surgical site after surgical resection
and whole-brain radiotherapy (WBRT).
- To estimate the rate of salvage WBRT, SRS, or surgery in patients treated with
neoadjuvant SRS alone.
- To determine the volume of adjacent normal brain parenchyma irradiated in these
- To estimate the rate of new brain metastases outside of the neoadjuvant SRS site in
- To estimate the quality of life of these patients after neoadjuvant SRS alone.
- To assess the effect of SRS and surgical intervention on the preservation of
neurocognitive functioning in these patients.
- To determine the clinical significance (mass effect, cognitive functioning, and other
symptoms) of locally recurrent brain metastases at the time of their occurrence in
- To estimate the rate of death due to neurologic causes, defined as death attributable
to the progression of neurological disease, in these patients.
- To estimate the overall survival of these patients.
OUTLINE: Patients undergo stereotactic radiosurgery over 30 to 90 minutes. Approximately 2-4
weeks later, patients undergo surgical resection of brain metastasis.
Quality of life and neurocognitive function are assessed periodically using the FACT-Br
subscales and Mini-Mental State Exam.
After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months for 1 year.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Recurrence rate at the surgical site within 12 months after neoadjuvant stereotactic radiosurgery (SRS) as measured by MRI
John H. Sampson, MD, PhD
United States: Food and Drug Administration
|Duke University Medical Center||Durham, North Carolina 27710|