Neurocognition After Gamma Knife Radiosurgery for Multiple Brian Metastases

Study Overview
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Brief Summary
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Cancer which spreads to the brain (brain metastases) is a common and significant problem. Historically, whole-brain radiotherapy has been used to treat these patients but has a negative effect on cognition. Radiosurgery is an alternative treatment with potential for fewer cognitive side effects. The impact of radiosurgery alone on the cognitive function of patients with multiple brain metastases is not well studied. We propose a pilot study at the Winnipeg Centre for Gamma Knife Surgery to examine this issue.

Detailed Description
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Patients with >=4 brain metastases will undergo Gamma Knife radiosurgery to a dose of 15-20 Gy, depending on the maximum tumour diameter and number of metastases. A number of neurocognitive, quality of life, and toxicity assessments will be performed at baseline and at 6 weeks post-radiosurgery, then at months 4, 6, 12, 18, and every 6 months thereafter.

Official Title
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Neurocognition After Gamma Knife Radiosurgery for Multiple Brian Metastases

Conditions
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Neoplasm Metastases

Intervention / Treatment
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* Radiation: Gamma knife radiosurgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically proven solid tumour malignancy Age >= 18 years Karnofsky performance status >= 70 >= 4 brain metastases, all eligible to be treated with radiosurgery All brain metastases <= 4.0 cm in any diameter Pre-treatment contrast enhanced MRI brain <= 42 days prior to enrollment Patient able to provide his/her own written informed consent Exclusion Criteria: Prior radiosurgery, whole brain radiotherapy, or cranial radiotherapy Previous surgical resection of brain metastasis (biopsy is allowed) Prior chemotherapy ≤ 7 days prior to enrollment Planned chemotherapy during radiosurgery Leukemia, lymphoma, germ-cell tumour, small-cell lung cancer diagnosis Brainstem metastasis Leptomeningeal metastases Contraindication to MR imaging with contrast Pregnant or nursing women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Brain metastases (>= 4)<br>Patients with pathologically proven solid tumour malignancy who have >=4 brain metastases will be treated with gamma knife radiosurgery. | Radiation: Gamma knife radiosurgery<br>* Depending on maximum tumour diameter, patients will receive a single dose of 15-20 Gy to the isodose surface which encompasses the entire metastasis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hopkins Verbal Learning Test - Revised (HVLT-R) |  | 4 months after radiosurgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognitive battery | Other neurocognitive tests will include Trail making test A and B (TMT), Controlled Oral Word Association (COWAT), Test of Premorbid Functioning, Ruff Figural Fluency Test, Animal Naming, Brief Visuospatial Memory Test - Revised, WMS-III Digit Span, WMS-III Spatial Span, and the Symbol Digit Modalities Test. | 4 months after radiosurgery | 
| Quality of Life | European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 15 Palliative (QLQ-C15-PAL) Brain cancer specific quality of life questionnaire (QLQ-BN20) | 4 months after radiosurgery | 
| Common Terminology Criteria for Adverse Events (CTCAE) v4.0 |  | 4 months after radiosurgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neoplasm metastasis, Brain neoplasms, Radiosurgery, Cognition disorders, Cranial irradiation