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Poor accrual. Investigator decision.
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| Name | Class |
|---|---|
| Health Sciences Centre Foundation, Manitoba | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brain metastases (>= 4) | Patients with pathologically proven solid tumour malignancy who have >=4 brain metastases will be treated with gamma knife radiosurgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gamma knife radiosurgery | Radiation | Depending on maximum tumour diameter, patients will receive a single dose of 15-20 Gy to the isodose surface which encompasses the entire metastasis. |
| Measure | Description | Time Frame |
|---|---|---|
| Hopkins Verbal Learning Test - Revised (HVLT-R) | 4 months after radiosurgery |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to in-field and distant radiographic progression | 1 year | |
| Duration of functional independence (Barthel ADL index) | 1 year | |
| Neurologic death rate |
Inclusion Criteria:
Exclusion Criteria:
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Patients with multiple (>= 4) brain metastases undergoing radiosurgery at the Winnipeg Centre for Gamma Knife Surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Harvey Quon, MD | CancerCare Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Sciences Centre / CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D001932 | Brain Neoplasms |
| D003072 | Cognition Disorders |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| Quality of Life |
| 4 months after radiosurgery |
| Common Terminology Criteria for Adverse Events (CTCAE) v4.0 | 4 months after radiosurgery |
| 1 year |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |