Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Phase II Single-arm Study of Pre-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 before surgery may make
the tumor smaller and reduce the amount of normal tissue that needs to be removed.
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 neoadjuvant stereotactic radiosurgery (SRS) compared with
historical data documenting recurrence at the surgical site after surgical resection
and whole-brain radiotherapy (WBRT).
Secondary
- 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
patients.
- To estimate the rate of new brain metastases outside of the neoadjuvant SRS site in
these patients.
- 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
these patients.
- 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
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