Phase II Single-arm Study of Post-operative Stereotactic Radiosurgery for Brain Metastases.
- To estimate the rate of recurrence at the surgical site in patients with brain
metastases treated with adjuvant stereotactic radiosurgery (SRS) compared with
historical data documenting recurrence at the surgical site after surgery and whole
brain radiotherapy (WBRT).
- To estimate the rate of salvage WBRT, SRS, or surgery in patients treated with adjuvant
- To estimate the rate of new brain metastases outside of the adjuvant SRS site.
- To estimate patient quality of life after adjuvant SRS alone.
- To assess the effect of surgical intervention and SRS on the preservation of
neurocognitive functioning in these patients.
- To determine the clinical significance (if any) of locally recurrent brain metastases
at the time of their occurrence (mass effect, cognitive functioning, and other
symptoms) in these patients.
- To estimate the rate of death due to neurologic causes, defined as death attributable
to the progression of neurological disease.
- To estimate the overall survival of these patients.
OUTLINE: Patients undergo stereotactic radiosurgery over 30-90 minutes.
Quality of life and neurocognitive function are assessed periodically.
After completion of study therapy, patients are followed every 3 months for 1 year and then
every 6 months for 1 year.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Recurrence Rate at the Surgical Site as Measured by MRI
The number of months for local recurrence via MRI
John H. Sampson, MD, PhD
United States: Institutional Review Board
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|