Neurocognition After Gamma Knife Radiosurgery for Multiple Brian Metastases

N/ATerminatedNCT01970644

CancerCare Manitoba3 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Neoplasm Metastases

Interventions

Gamma knife radiosurgeryRADIATION

Depending on maximum tumour diameter, patients will receive a single dose of 15-20 Gy to the isodose surface which encompasses the entire metastasis.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Health Sciences Centre / CancerCare Manitoba

Winnipeg, Manitoba, Canada

Outcomes

Primary Outcomes

Hopkins Verbal Learning Test - Revised (HVLT-R)

Time frame: 4 months after radiosurgery

Secondary Outcomes

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.

Time frame: 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)

Time frame: 4 months after radiosurgery

Common Terminology Criteria for Adverse Events (CTCAE) v4.0

Time frame: 4 months after radiosurgery

Data from ClinicalTrials.gov

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