Neurocognition After Gamma Knife Radiosurgery for Multiple Brian Metastases

Sponsor

CancerCare Manitoba (Other)

Overall Status

Terminated

CT.gov ID

NCT01970644

Collaborator

Health Sciences Centre Foundation, Manitoba (Other)

Enrollment

Location

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasm Metastases	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 Design

Study Type:

Observational

Actual Enrollment :

3 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Neurocognition After Gamma Knife Radiosurgery for Multiple Brian Metastases

Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Hopkins Verbal Learning Test - Revised (HVLT-R) [4 months after radiosurgery]

Secondary Outcome Measures

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]