Neurocognition After Gamma Knife Radiosurgery for Multiple Brian Metastases

Terminated

• Conditions: Neoplasm Metastases
• Interventions: Radiation: Gamma knife radiosurgery

• Registration Number: NCT01970644
• Lead Sponsor: CancerCare Manitoba

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.

Study Timeline

• Study First Submitted: 2013-10-23
• Study First Submitted QC: 2013-10-23
• Study First Posted: 2013-10-28
• Study Start: 2014-04
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-27
• Last Update Posted: 2016-05-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Brain metastases (>= 4)	Gamma knife radiosurgery	Patients with pathologically proven solid tumour malignancy who have \>=4 brain metastases will be treated with gamma knife radiosurgery.

Primary Outcome Measures

Name	Time	Method
Hopkins Verbal Learning Test - Revised (HVLT-R)	4 months after radiosurgery

Secondary Outcome Measures

Name	Time	Method
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)
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.
Common Terminology Criteria for Adverse Events (CTCAE) v4.0	4 months after radiosurgery

Trial Locations

Locations (1)

Health Sciences Centre / CancerCare Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada