Neurocognition After Gamma Knife Radiosurgery for Multiple Brian Metastases

CancerCare Manitoba

Status: Terminated

Conditions: Neoplasm Metastases

Treatments: Radiation: Gamma knife radiosurgery

Study type: Observational

Funder types: Other

Identifiers

NCT01970644

B2013:129

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

3 participants in 1 patient group

Brain metastases (>= 4)

Description:

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

Treatment:

Radiation: Gamma knife radiosurgery