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Neurocognition After Gamma Knife Radiosurgery for Multiple Brian Metastases

NCT ID: NCT01970644

Last Updated: 2016-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-09-30

Brief Summary

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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

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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.

Conditions

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Neoplasm Metastases

Keywords

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Neoplasm metastasis Brain neoplasms Radiosurgery Cognition disorders Cranial irradiation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Brain metastases (>= 4)

Patients with pathologically proven solid tumour malignancy who have \>=4 brain metastases will be treated with gamma knife radiosurgery.

Gamma knife radiosurgery

Intervention Type RADIATION

Depending on maximum tumour diameter, patients will receive a single dose of 15-20 Gy to the isodose surface which encompasses the entire metastasis.

Interventions

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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.

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Health Sciences Centre Foundation, Manitoba

OTHER

Sponsor Role collaborator

CancerCare Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Harvey Quon, MD

Role: PRINCIPAL_INVESTIGATOR

CancerCare Manitoba

Locations

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Health Sciences Centre / CancerCare Manitoba

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

Other Identifiers

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B2013:129

Identifier Type: -

Identifier Source: org_study_id