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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Surgery of a single brain metastasis.
Pre-operative single fraction SRS
Duke University Medical Center
Durham, North Carolina, United States
Number of Patients With Local Recurrence at the Surgical Site Within 12 Months After Stereotactic Radiosurgery (SRS)
Number of patients with local recurrence at the surgical site within 12 months after stereotactic radiosurgery (SRS) as measured by magnetic resonance imaging (MRI). To determine local recurrence, we evaluated follow-up MRI's for reappearance of a lesion in exactly the same site in the brain as the first lesion(s).
Time frame: Within 12 months after SRS
Number of Patients Receiving Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery
Number of patients receiving salvage whole-brain radiotherapy, stereotactic radiosurgery (SRS), or surgery
Time frame: Within 24 months post-SRS
Volume of Adjacent Normal Brain Parenchyma Irradiated
Volume of adjacent normal brain parenchyma irradiated during stereotactic radiosurgery (SRS).
Time frame: At time of SRS
Number of Patients With New Brain Metastases Outside of the Pre-operative Stereotactic Radiosurgery (SRS) Site
Number of patients with new brain metastases outside of the pre-operative stereotactic radiosurgery (SRS) site.
Time frame: Within 24 months post-SRS
Quality of Life After Stereotactic Radiosurgery (SRS) as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br)
Quality of life as measured by the change in FACT-Br scores from baseline. The FACT-Br (version 4) is comprised of the Functional Assessment of Cancer Therapy-General (FACT-G), a 27-item core questionnaire evaluating the domains of physical, family/social, emotional and functional well-being, with the addition of 23 brain cancer specific questions. The FACT-G total score is the sum of the four FACT-G domain scores. The Brain Cancer Subscale (BrCS) is the sum of 19 brain cancer specific questions. The FACT-Br Trial Outcome Index (TOI) is the sum of the BrCS score and the physical and family/social domain scores. The FACT-Br total score is the sum of the FACT-G total score and the BrCS score. Change score = score post-SRS minus the score at baseline. Positive change scores indicate improved quality of life.
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Time frame: Administered at baseline and every 3 months post-SRS
Preservation of Neurocognitive Functioning as Measure by the Mini-Mental State Exam (MMSE)
Cognition as measured by the change in the Mini-Mental State Exam (MMSE) scores from baseline. The MMSE is an 11-item measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall and language. The maximum score is 30. Change score = score post-SRS minus the score at baseline. Positive change scores indicate improved cognition.
Time frame: Administered at baseline and every 3 months post-SRS
Clinical Significance of Locally Recurrent Brain Metastases
Number of patients with clinical significance (mass effect, cognitive functioning, and other symptoms) of locally recurrent brain metastases at the time of their occurrence.
Time frame: 24 months post-SRS
Number of Patients Who Died Due to Neurological Causes
Number of patients who died due to neurological causes defined as death attributable to the progression of neurological disease.
Time frame: Within 24 months post-SRS
Overall Survival (OS)
Time in months from the date of stereotactic radiosurgery (SRS) to the date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.
Time frame: 24 months after SRS