Neurocognition After Gamma Knife Radiosurgery for Multiple Brian Metastases

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.

Study Overview

• Status: Terminated
• Conditions: Neoplasm Metastases
• Intervention / Treatment: Radiation: Gamma knife radiosurgery

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 Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • Health Sciences Centre / CancerCare Manitoba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with multiple (>= 4) brain metastases undergoing radiosurgery at the Winnipeg Centre for Gamma Knife Surgery.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Brain metastases (>= 4); Patients with pathologically proven solid tumour malignancy who have >=4 brain metastases will be treated with gamma knife radiosurgery.	Radiation: Gamma 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Time Frame
Time to in-field and distant radiographic progression	1 year
Duration of functional independence (Barthel ADL index)	1 year
Neurologic death rate	1 year

Collaborators and Investigators

• Sponsor: CancerCare Manitoba
• Collaborators: Health Sciences Centre Foundation, Manitoba
• Investigators: Principal Investigator: Harvey Quon, MD, CancerCare Manitoba

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (ACTUAL): September 1, 2015
• Study Completion (ACTUAL): September 1, 2015

Study Registration Dates

• First Submitted: October 23, 2013
• First Submitted That Met QC Criteria: October 23, 2013
• First Posted (ESTIMATE): October 28, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): May 30, 2016
• Last Update Submitted That Met QC Criteria: May 27, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Brain neoplasms; Radiosurgery; Cognition disorders; Neoplasm metastasis; Cranial irradiation
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplastic Processes; Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: B2013:129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO