Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Phase II Single-arm Study of Post-operative Stereotactic Radiosurgery for Brain Metastases.
RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and
cause less damage to normal tissue. Giving stereotactic radiosurgery after surgery may kill
any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well stereotactic radiosurgery works in treating
patients with brain metastases.
OBJECTIVES:
Primary
- 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).
Secondary
- To estimate the rate of salvage WBRT, SRS, or surgery in patients treated with adjuvant
SRS alone.
- 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.
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