Neoplasm MetastasesNCT01970644
Neurocognition After Gamma Knife Radiosurgery for Multiple Brian Metastases
An observational study of Neoplasm Metastases, run by CancerCare Manitoba at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Metastases
- What is being tested?
- Gamma knife radiosurgery
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with multiple (>= 4) brain metastases undergoing radiosurgery at the Winnipeg Centre for Gamma Knife Surgery.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Leptomeningeal metastases
- Contraindication to MR imaging with contrast
- Pregnant or nursing women
Trial locations and contacts
1 site in 1 country.
Canada1 site
Health Sciences Centre / CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
About this study
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.
Read the 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
- Being tested
- Gamma knife radiosurgery
- Keywords
- Neoplasm metastasis, Brain neoplasms, Radiosurgery, Cognition disorders, Cranial irradiation
- Medical subject headings
- Neoplasm Metastasis, Brain Neoplasms, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamma knife radiosurgeryRadiation
Depending on maximum tumour diameter, patients will receive a single dose of 15-20 Gy to the isodose surface which encompasses the entire metastasis.
| Study group | Role | What they receive |
|---|---|---|
| Brain metastases (>= 4) | Patients with pathologically proven solid tumour malignancy who have >=4 brain metastases will be treated with gamma knife radiosurgery. Receives: Radiation: Gamma knife radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hopkins Verbal Learning Test - Revised (HVLT-R)
Measured: 4 months after radiosurgery
Secondary outcomes (3)
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.
Measured: 4 months after radiosurgery
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)
Measured: 4 months after radiosurgery
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Measured: 4 months after radiosurgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study startApr 2014
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: Poor accrual. Investigator decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- CancerCare Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Health Sciences Centre Foundation, Manitoba
- Responsible party
- Sponsor
- Investigators
- Harvey Quon, MD, Principal investigator, CancerCare Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970644
- Sponsor's protocol ID
- B2013:129
- Status last verified
- May 2016
- First submitted
- 23 Oct 2013
- Last updated
- 30 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognition After Gamma Knife Radiosurgery for Multiple Brian Metastases
- ClinicalTrials.gov ID
- NCT01970644
- Acronym / sponsor ID
- B2013:129
- Conditions
- Neoplasm Metastases
- Keywords
- Neoplasm metastasis, Brain neoplasms, Radiosurgery, Cognition disorders, Cranial irradiation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor accrual. Investigator decision.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- CancerCare ManitobaUniversity, hospital or other
- Collaborators
- Health Sciences Centre Foundation, Manitoba
- Study start
- Apr 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 28 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain metastases (>= 4) | – | Radiation: Gamma knife radiosurgeryPatients with pathologically proven solid tumour malignancy who have >=4 brain metastases will be treated with gamma knife radiosurgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with multiple (>= 4) brain metastases undergoing radiosurgery at the Winnipeg Centre for Gamma Knife Surgery.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gamma knife radiosurgeryDepending on maximum tumour diameter, patients will receive a single dose of 15-20 Gy to the isodose surface which encompasses the entire metastasis. | Radiation | Brain metastases (>= 4) |
Primary outcome
Hopkins Verbal Learning Test - Revised (HVLT-R)
Time frame: 4 months after radiosurgery
3 secondary outcomes
Neurocognitive battery
Time frame: 4 months after radiosurgery
Quality of Life
Time frame: 4 months after radiosurgery
Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: 4 months after radiosurgery
Results and safety
The study was stopped early (reason given: Poor accrual. Investigator decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harvey Quon, MD principal investigator
CancerCare Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasm Metastases, run by CancerCare Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor accrual. Investigator decision.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hopkins Verbal Learning Test - Revised (HVLT-R) (time frame: 4 months after radiosurgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2016.