Neurocognition After Gamma Knife Radiosurgery for Multiple Brian Metastases

May 27, 2016 updated by: CancerCare Manitoba
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Health Sciences Centre / CancerCare Manitoba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with multiple (>= 4) brain metastases undergoing radiosurgery at the Winnipeg Centre for Gamma Knife Surgery.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Brain metastases (>= 4)
Patients with pathologically proven solid tumour malignancy who have >=4 brain metastases will be treated with gamma knife radiosurgery.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Hopkins Verbal Learning Test - Revised (HVLT-R)
Time Frame: 4 months after radiosurgery
4 months after radiosurgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Neurocognitive battery
Time Frame: 4 months after radiosurgery
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
Quality of Life
Time Frame: 4 months after radiosurgery
  • 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
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time Frame: 4 months after radiosurgery
4 months after radiosurgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Time to in-field and distant radiographic progression
Time Frame: 1 year
1 year
Duration of functional independence (Barthel ADL index)
Time Frame: 1 year
1 year
Neurologic death rate
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CancerCare Manitoba

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Health Sciences Centre Foundation, Manitoba

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Harvey Quon, MD, CancerCare Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B2013:129

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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