Brain MetastasesNCT01821443
A Single Arm Study of Neurocognitive Outcomes in Patients With Brain Metastases Managed With Stereotactic Radiosurgery (SRS)
A study testing Stereotactic radiosurgery (SRS) in people with Brain Metastases, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to find out what effects, good and/or bad, stereotactic radiosurgery (Gamma knife) has on brain metastasis(es). Gamma knife radiosurgery is a way of giving radiation therapy to the brain in a very focused way, so that nearby parts of the brain receive very little exposure to radiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases
- What is being tested?
- Stereotactic radiosurgery (SRS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to 22 Oct 2015
- Phase
- Interventional
- 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
Who may be able to join
- Pathologically (histologically or cytologically) proven diagnosis of a non-hematopoietic malignancy other than small cell lung cancer and germ cell malignancy within 5 years of registration. If the original histologic proof of malignancy is greater than 5 years, then pathological confirmation is required (e.g. from extra- or intracranial disease).
- Patients with 1-10 measurable brain metastases on a diagnostic-quality contrast-enhanced magnetic resonance imaging (MRI) scan obtained within 30 days prior to registration.
- Patients with ≤10 cc largest tumor volume, and ≤15 cc total tumor volume.
- History/physical examination within 30 days prior to registration.
- If an open biopsy is performed, the patient must be at least one week post biopsy. This requirement does not apply to patients who undergo stereotactic biopsies.
- Age ≥18 years.
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- Karnofsky performance status ≥70 (RTOG recursive partitioning analysis (RPA) Class I \& II).
- Minimum pre-treatment oNCF score ≥70.
- Patients must provide study-specific informed consent prior to study entry.
- Women of child-bearing age must have a negative, quantitative serum pregnancy test ≤14 days prior to study entry, or have a documented reason why such a test is not necessary (e.g. history of tubal ligation).
- Patients must be able to speak and read English fluently (required for the use of online NCF testing).
Who cannot join
- Clinical (e.g. multiple cranial nerve deficits in the absence of obvious radiographic disease to explain symptoms) or radiographic evidence of leptomeningeal disease.
- Patients with measurable brain metastasis(es) resulting from small cell lung cancer and/or germ cell malignancy
- No documentation of prior cytotoxic or other therapy for malignancy if such therapy was previously received. Note: This does not apply to patients with synchronous metastases at initial diagnosis.
- Contraindication to MR imaging, such as implanted metal devices or foreign bodies, severe claustrophobia, or contraindications to contrast agent administration.
- Estimated glomerular filtration rate (eGFR) <60 within 6 weeks prior to registration.
- Prior radiation therapy to the brain.
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- Severe, active co-morbidity, defined as follows:
- Unstable angina, and/or congestive heart failure requiring hospitalization within the last 6 months.
- Transmural myocardial infarction within the last 6 months.
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization, or precluding study therapy at the time of registration.
- Uncontrolled, clinically significant cardiac arrhythmias.
- Radiologic or clinical evidence of hydrocephalus, or history of previously treated hydrocephalus.
- Women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved in this study is potentially teratogenic.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: A Single Arm Study of Neurocognitive Outcomes in Patients With Brain Metastases Managed Primarily With Stereotactic Radiosurgery (SRS)
The purpose of this study is to find out what effects, good and/or bad, stereotactic radiosurgery (Gamma knife) has on brain metastasis(es). Gamma knife radiosurgery is a way of giving radiation therapy to the brain in a very focused way, so that nearby parts of the brain receive very little exposure to radiation. No incisions are involved. Imaging technology is used to pinpoint the location of the tumor.
In this study, the investigators are also trying to find out how the tumor and/or treatment affect brain function over time. The investigators will do this by performing a series of neurocognitive assessments, or tests of memory, reasoning, and higher brain function, before treatment and at regular intervals after treatment.
Read the detailed description
This will be a prospective, multi-institution, non-randomized trial of neurocognitive outcomes in patients with multiple, newly-diagnosed brain metastases managed primarily with stereotactic radiosurgery (SRS), specifically the Gamma Knife (GK) system. The goal of the study is to enroll 45 patients with 1-10 newly-diagnosed brain metastases from varied primary cancers with the largest intracranial tumor volume ≤10 cc, ≤15 cc total tumor volume, absence of leptomeningeal disease on MRI, and Karnofsky performance status (KPS) score ≥70 (unless due to intracranial disease), and KPS expected to improve to ≥70 with treatment. The enrolled patients are expected to have fairly good pre-treatment cognitive function, defined as online neurocognitive function (oNCF) assessment scores ≥70 (within 2 standard deviations of mean, 100).
All study participants will undergo standard, pre-treatment clinical evaluations that include: complete clinical/neurologic exam, performance status assessment, systemic staging, and diagnostic MRI of the brain. Upon enrollment, the patients will further undergo high-resolution MRI, including track density imaging (TDI). The baseline neurocognitive function (NCF) will be assessed by a short (20-30 minute) online test battery that can be completed by patients at home, CogState assessment (22 minutes), as well as by a comprehensive neuropsychological evaluation (2-3 hours). The eligible patients will subsequently go on to receive a radiosurgical treatment for their brain metastases.
All patients will have treatment response assessments every 10-12 weeks consisting of a clinical/neurologic exam, performance status evaluation, disease re-staging (if indicated), and diagnostic MRI of the brain. If progressive disease is identified (radiographic progression of treated lesions or new brain lesions), the patients will be considered for "salvage" therapy which will include repeat SRS, whole-brain radiation therapy (WBRT), surgery with or without brachytherapy or best supportive care (e.g. steroids only). The preferred salvage therapy will be SRS provided that the re-treatment criteria are met. Along with regular clinical MRIs, TDI will be obtained.
Mandatory comprehensive follow-up testing by a neuropsychologist (1-2 hours) will occur every 10-12 weeks, starting 4 weeks after completion of SRS, and will continue at these intervals even if salvage therapy is administered for intracranial recurrence. Online NCF testing (oNCF and CogState) will take place in the office setting on the same day as a comprehensive cognitive assessment. Patients will also have the option to do web-based oNCF assessments from home but not more frequently than every 2 weeks. These optional assessments will not be included in the data analysis. All study participants will be followed until death or withdrawal from the study.
The primary aim of the study is to validate the oNCF battery and to demonstrate the feasibility of its use in patients with metastatic brain disease. The former will be accomplished by correlating the findings of the oNCF testing with those of a comprehensive neurocognitive function (cNCF) assessment of a neuropsychologist. Every attempt will be made to identify imaging correlates of neurocognitive function derived from high-resolution MRI, and TDI. The aggregate data in combination with lesion location information (and the corresponding treatment) should provide unique insights into mechanisms that underlie radiation therapy (RT)-related brain injury. Because salvage therapy with WBRT is also permitted and will likely be necessary in a subset of patients, some insights may also be gained on the relative extent, specificity, and temporal evolution of post-treatment NCF dysfunction of each treatment modality.
The data gained from this pilot study could form the basis of future trials of NCF outcomes in cancer patients, especially if oNCF test battery is validated as this may provide a cost-effective method for including NCF outcomes in clinical trials.
- Conditions
- Brain Metastases
- Being tested
- Stereotactic radiosurgery (SRS)
- Keywords
- 1 to 10 measurable brain metastases
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic radiosurgery (SRS)Other
Also called Gamma Knife® Perfexion™ radiosurgical system
Dose \& prescription The dose will be prescribed to the isodose surface, which encompasses the margin of the metastasis (50-90% [maximum=100%]), as defined by target delineation on the imaging studies.
The prescribed dose is dependent on the prescription isodose volume (IDV). The prescription IDV is defined as the volume (cm3) that is encompassed by the prescription isodose line (IDL).
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Radiosurgery (SRS) | Experimental | Stereotactic radiosurgery technique via Gamma Knife® Perfexion™ radiosurgical system Receives: Other: Stereotactic radiosurgery (SRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gamma knife radiosurgery treatment
Two short oNCF assessments will be performed at least 30 minutes prior to a clinical neurocognitive function (cNCF) assessments directed by a neuropsychologist at baseline and 6 months following Gamma knife treatment to assess changes in the participants' ability to complete all assessments.
Measured: Baseline and 6-months following treatment
Validation: To estimate consistency in change in z-scores for online oNCF and comprehensive clinical neurocognitive function (cNCF) neurocognitive assessments at baseline and 6-months in the office/clinic setting.
- Neuro psychologist will perform assessments: global cognitive function (Montreal Cognitive Assessment (MoCA), fine motor skills (Grooved Pegboard), information processing speed (DKEFS Trails, Symbol-Digit Modality Test), auditory and visual attention (NAB Digit Span, Numbers and Letters A), verbal memory (NAB List Learning and Story Learning), visual memory (NAB Shape Learning and Rey-Osterrieth Complex Figure (ROCF), Brief Visuospatial Memory Test-Revised (BVMT-R™), language (Boston Naming Test, Letter Fluency, Category Fluency, Sentence Repetition), visual-spatial (NAB Visual Discrimination, ROCF) and DKEFS Trails, DKEFS Design Fluency).
- Patient will complete Quality of Life Questionnaire- Core 30 (QOL-30), Brain Cancer Module-20 (BCM20), and EuroQol Group Questionnaire-5D (EQ-5D) QoL measurements.
- Patient will complete self-reported measures of depression (BDI-II), anxiety (BAI), qualify of life (FACT-Br), cognition (FACT-COG), and fatigue (Fatigue Severity Scale).
Measured: baseline and 6-months following radiosurgery
Secondary outcomes (2)
-Feasibility: To demonstrate that at least 95% of participants will have no change from baseline and 12 months after treatment in their ability to complete the online neurocognitive function (oNCF) assessment.
Two short online neurocognitive (oNCF) assessments will be performed. All patients will be required to complete oNCF testing at least 30 minutes prior to a clinical neurocognitive function (cNCF) assessment directed by a neuropsychologist.
Measured: baseline and 12-months after therapy.
- Validation: To estimate consistency and change in scores for online neurocognitive (oNCF) and comprehensive clinical neurocognitive function (cNCF) assessments over all study time points.
To estimate consistency in change in scores for oNCF and cNCF assessments at all study time points. This assessment of change over time can be achieved by employing an analysis of covariance model that relates the continuous assessment outcome to the classification factor (oNCF or cNCF) and the continuous covariate, time of neurocognitive exam, as well as an interaction term. Estimates of zero for the interaction term and classification factor will indicate consistency.
Measured: baseline and 12-months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study startDec 2012
- Primary completion22 Oct 2015
- Study completion22 Oct 2015
Why it stopped: Loss of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- North American Gamma Knife Consortium
- Responsible party
- Sponsor
- Investigators
- Igor J Barani, MD, Study chair, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821443
- Sponsor's protocol ID
- 12105/12-02
- Status last verified
- Jan 2018
- First submitted
- 13 Mar 2013
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Study of Neurocognitive Outcomes in Patients With Brain Metastases Managed Primarily With Stereotactic Radiosurgery (SRS)
- ClinicalTrials.gov ID
- NCT01821443
- Acronym / sponsor ID
- 12105/12-02
- Conditions
- Brain Metastases
- Keywords
- 1 to 10 measurable brain metastases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Loss of funding
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- North American Gamma Knife Consortium
- Study start
- Dec 2012
- Primary completion
- 22 Oct 2015 (actual)
- Study completion
- 22 Oct 2015 (actual)
- First posted
- 1 Apr 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.
The purpose of this study is to find out what effects, good and/or bad, stereotactic radiosurgery (Gamma knife) has on brain metastasis(es). Gamma knife radiosurgery is a way of giving radiation therapy to the brain in a very focused way, so that nearby parts of the brain receive very little exposure to radiation. No incisions are involved. Imaging technology is used to pinpoint the location of the tumor.
In this study, the investigators are also trying to find out how the tumor and/or treatment affect brain function over time. The investigators will do this by performing a series of neurocognitive assessments, or tests of memory, reasoning, and higher brain function, before treatment and at regular intervals after treatment.
Detailed description
This will be a prospective, multi-institution, non-randomized trial of neurocognitive outcomes in patients with multiple, newly-diagnosed brain metastases managed primarily with stereotactic radiosurgery (SRS), specifically the Gamma Knife (GK) system. The goal of the study is to enroll 45 patients with 1-10 newly-diagnosed brain metastases from varied primary cancers with the largest intracranial tumor volume ≤10 cc, ≤15 cc total tumor volume, absence of leptomeningeal disease on MRI, and Karnofsky performance status (KPS) score ≥70 (unless due to intracranial disease), and KPS expected to improve to ≥70 with treatment. The enrolled patients are expected to have fairly good pre-treatment cognitive function, defined as online neurocognitive function (oNCF) assessment scores ≥70 (within 2 standard deviations of mean, 100).
All study participants will undergo standard, pre-treatment clinical evaluations that include: complete clinical/neurologic exam, performance status assessment, systemic staging, and diagnostic MRI of the brain. Upon enrollment, the patients will further undergo high-resolution MRI, including track density imaging (TDI). The baseline neurocognitive function (NCF) will be assessed by a short (20-30 minute) online test battery that can be completed by patients at home, CogState assessment (22 minutes), as well as by a comprehensive neuropsychological evaluation (2-3 hours). The eligible patients will subsequently go on to receive a radiosurgical treatment for their brain metastases.
All patients will have treatment response assessments every 10-12 weeks consisting of a clinical/neurologic exam, performance status evaluation, disease re-staging (if indicated), and diagnostic MRI of the brain. If progressive disease is identified (radiographic progression of treated lesions or new brain lesions), the patients will be considered for "salvage" therapy which will include repeat SRS, whole-brain radiation therapy (WBRT), surgery with or without brachytherapy or best supportive care (e.g. steroids only). The preferred salvage therapy will be SRS provided that the re-treatment criteria are met. Along with regular clinical MRIs, TDI will be obtained.
Mandatory comprehensive follow-up testing by a neuropsychologist (1-2 hours) will occur every 10-12 weeks, starting 4 weeks after completion of SRS, and will continue at these intervals even if salvage therapy is administered for intracranial recurrence. Online NCF testing (oNCF and CogState) will take place in the office setting on the same day as a comprehensive cognitive assessment. Patients will also have the option to do web-based oNCF assessments from home but not more frequently than every 2 weeks. These optional assessments will not be included in the data analysis. All study participants will be followed until death or withdrawal from the study.
The primary aim of the study is to validate the oNCF battery and to demonstrate the feasibility of its use in patients with metastatic brain disease. The former will be accomplished by correlating the findings of the oNCF testing with those of a comprehensive neurocognitive function (cNCF) assessment of a neuropsychologist. Every attempt will be made to identify imaging correlates of neurocognitive function derived from high-resolution MRI, and TDI. The aggregate data in combination with lesion location information (and the corresponding treatment) should provide unique insights into mechanisms that underlie radiation therapy (RT)-related brain injury. Because salvage therapy with WBRT is also permitted and will likely be necessary in a subset of patients, some insights may also be gained on the relative extent, specificity, and temporal evolution of post-treatment NCF dysfunction of each treatment modality.
The data gained from this pilot study could form the basis of future trials of NCF outcomes in cancer patients, especially if oNCF test battery is validated as this may provide a cost-effective method for including NCF outcomes in clinical trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Radiosurgery (SRS) | Experimental | Other: Stereotactic radiosurgery (SRS)Stereotactic radiosurgery technique via Gamma Knife® Perfexion™ radiosurgical system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Pathologically (histologically or cytologically) proven diagnosis of a non-hematopoietic malignancy other than small cell lung cancer and germ cell malignancy within 5 years of registration. If the original histologic proof of malignancy is greater than 5 years, then pathological confirmation is required (e.g. from extra- or intracranial disease).
- Patients with 1-10 measurable brain metastases on a diagnostic-quality contrast-enhanced magnetic resonance imaging (MRI) scan obtained within 30 days prior to registration.
- Patients with ≤10 cc largest tumor volume, and ≤15 cc total tumor volume.
- History/physical examination within 30 days prior to registration.
- If an open biopsy is performed, the patient must be at least one week post biopsy. This requirement does not apply to patients who undergo stereotactic biopsies.
Key exclusion criteria (15 listed)
- Clinical (e.g. multiple cranial nerve deficits in the absence of obvious radiographic disease to explain symptoms) or radiographic evidence of leptomeningeal disease.
- Patients with measurable brain metastasis(es) resulting from small cell lung cancer and/or germ cell malignancy
- No documentation of prior cytotoxic or other therapy for malignancy if such therapy was previously received. Note: This does not apply to patients with synchronous metastases at initial diagnosis.
- Contraindication to MR imaging, such as implanted metal devices or foreign bodies, severe claustrophobia, or contraindications to contrast agent administration.
- Estimated glomerular filtration rate (eGFR) <60 within 6 weeks prior to registration.
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 |
|---|---|---|
| Stereotactic radiosurgery (SRS)Also: Gamma Knife® Perfexion™ radiosurgical systemDose \& prescription The dose will be prescribed to the isodose surface, which encompasses the margin of the metastasis (50-90% [maximum=100%]), as defined by target delineation on the imaging studies. The prescribed dose is dependent on the prescription isodose volume (IDV). The prescription IDV is defined as the volume (cm3) that is encompassed by the prescription isodose line (IDL). | Other | Stereotactic Radiosurgery (SRS) |
Primary outcome
Gamma knife radiosurgery treatment
Time frame: Baseline and 6-months following treatment
Two short oNCF assessments will be performed at least 30 minutes prior to a clinical neurocognitive function (cNCF) assessments directed by a neuropsychologist at baseline and 6 months following Gamma knife treatment to assess changes in the participants' ability to complete all assessments.
Validation: To estimate consistency in change in z-scores for online oNCF and comprehensive clinical neurocognitive function (cNCF) neurocognitive assessments at baseline and 6-months in the office/clinic setting.
Time frame: baseline and 6-months following radiosurgery
* Neuro psychologist will perform assessments: global cognitive function (Montreal Cognitive Assessment (MoCA), fine motor skills (Grooved Pegboard), information processing speed (DKEFS Trails, Symbol-Digit Modality Test), auditory and visual attention (NAB Digit Span, Numbers and Letters A), verbal memory (NAB List Learning and Story Learning), visual memory (NAB Shape Learning and Rey-Osterrieth Complex Figure (ROCF), Brief Visuospatial Memory Test-Revised (BVMT-R™), language (Boston Naming Test, Letter Fluency, Category Fluency, Sentence Repetition), visual-spatial (NAB Visual Discrimination, ROCF) and DKEFS Trails, DKEFS Design Fluency). * Patient will complete Quality of Life Questionnaire- Core 30 (QOL-30), Brain Cancer Module-20 (BCM20), and EuroQol Group Questionnaire-5D (EQ-5D) QoL measurements. * Patient will complete self-reported measures of depression (BDI-II), anxiety (BAI), qualify of life (FACT-Br), cognition (FACT-COG), and fatigue (Fatigue Severity Scale).
2 secondary outcomes
-Feasibility: To demonstrate that at least 95% of participants will have no change from baseline and 12 months after treatment in their ability to complete the online neurocognitive function (oNCF) assessment.
Time frame: baseline and 12-months after therapy.
- Validation: To estimate consistency and change in scores for online neurocognitive (oNCF) and comprehensive clinical neurocognitive function (cNCF) assessments over all study time points.
Time frame: baseline and 12-months after treatment.
Results and safety
The study was stopped early (reason given: Loss of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
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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.
Igor J Barani, MD study chair
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic radiosurgery (SRS) in people with Brain Metastases, run by University of California, San Francisco at 1 site in United States.
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 11 inclusion and 15 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 23 Jan 2018. 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 United States. 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: Loss of funding). 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?
Gamma knife radiosurgery treatment (time frame: Baseline and 6-months following treatment). The study lists 2 primary outcomes in all. 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 23 Jan 2018.