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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01970644
Other study ID # B2013:129
Secondary ID
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


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
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