Neoplasm Metastases
Conditions
Keywords
Neoplasm metastasis, Brain neoplasms, Radiosurgery, Cognition disorders, Cranial irradiation
Brief summary
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
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.
Interventions
RADIATIONGamma knife radiosurgery
Depending on maximum tumour diameter, patients will receive a single dose of 15-20 Gy to the isodose surface which encompasses the entire metastasis.
Sponsors
Health Sciences Centre Foundation, Manitoba
CancerCare Manitoba
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hopkins Verbal Learning Test - Revised (HVLT-R) | 4 months after radiosurgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurocognitive battery | 4 months after radiosurgery | 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. |
| Quality of Life | 4 months after radiosurgery | * 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) |
| Common Terminology Criteria for Adverse Events (CTCAE) v4.0 | 4 months after radiosurgery | — |
Other
| Measure | Time frame |
|---|---|
| Duration of functional independence (Barthel ADL index) | 1 year |
| Neurologic death rate | 1 year |
| Time to in-field and distant radiographic progression | 1 year |
Countries
Canada
Outcome results
None listed