Neurocognition After Gamma Knife Radiosurgery for Multiple Brian Metastases

NCT ID: NCT01970644

Last Updated: 2016-05-30

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 3 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-09-30

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.

Conditions

Neoplasm Metastases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

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

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

Health Sciences Centre Foundation, Manitoba

OTHER

Sponsor Role: collaborator

CancerCare Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harvey Quon, MD

Role: PRINCIPAL_INVESTIGATOR

CancerCare Manitoba

Locations

Health Sciences Centre / CancerCare Manitoba

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

B2013:129

Identifier Type: -

Identifier Source: org_study_id