Neurocognition After Gamma Knife Radiosurgery for Multiple Brian Metastases

Neoplasm Metastases Clinical Trial

Official title:

Neurocognition After Gamma Knife Radiosurgery for Multiple Brian Metastases

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01970644
• Other study ID #: B2013:129
• Status: Terminated
• Phase: N/A
• First received: October 23, 2013
• Last updated: May 27, 2016
• Start date: April 2014
• Est. completion date: September 2015

Study information

• Verified date: May 2016
• Source: CancerCare Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neoplasm Metastases
• Neoplasm Metastasis

Intervention

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.

Locations

Country	Name	City	State
Canada	Health Sciences Centre / CancerCare Manitoba	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
CancerCare Manitoba	Health Sciences Centre Foundation, Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to in-field and distant radiographic progression		1 year	No
Other	Duration of functional independence (Barthel ADL index)		1 year	No
Other	Neurologic death rate		1 year	Yes
Primary	Hopkins Verbal Learning Test - Revised (HVLT-R)		4 months after radiosurgery	No
Secondary	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	No
Secondary	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	No
Secondary	Common Terminology Criteria for Adverse Events (CTCAE) v4.0		4 months after radiosurgery	Yes