Clinical trial NCT01970644: Neurocognition After Gamma Knife Radiosurgery for Multiple Brian Metastases
Official title: Neurocognition After Gamma Knife Radiosurgery for Multiple Brian Metastases
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Neoplasm Metastases
Keywords: Neoplasm metastasis
Brain neoplasms
Radiosurgery
Cognition disorders
Cranial irradiation
Lead sponsor: CancerCare Manitoba
Sponsor class: OTHER
Collaborators: name: Health Sciences Centre Foundation, Manitoba
First posted: 2013-10-28
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with multiple (\>= 4) brain metastases undergoing radiosurgery at the Winnipeg Centre for Gamma Knife Surgery.

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.

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

Primary outcomes:
measure: Hopkins Verbal Learning Test - Revised (HVLT-R)
timeFrame: 4 months after radiosurgery
Secondary outcomes:
measure: Neurocognitive battery
timeFrame: 4 months after radiosurgery
measure: Quality of Life
timeFrame: 4 months after radiosurgery
measure: Common Terminology Criteria for Adverse Events (CTCAE) v4.0
timeFrame: 4 months after radiosurgery
Other outcomes:
measure: Time to in-field and distant radiographic progression
timeFrame: 1 year
measure: Duration of functional independence (Barthel ADL index)
timeFrame: 1 year
measure: Neurologic death rate
timeFrame: 1 year
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre / CancerCare Manitoba
state: Manitoba
Study officials:
affiliation: CancerCare Manitoba
name: Harvey Quon, MD
role: PRINCIPAL_INVESTIGATOR
References: