Brain MetastasisNCT01445483
Neuropsychological Changes in Patients Receiving Radiation Therapy for Brain Metastases
An observational study of Brain Metastasis and Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: There are no standardized sets of tests to measure changes in neuropsychological functioning in patients treated for brain metastasis (cancer that has spread beyond the original site to the brain). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastasis, Cancer
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2009to not given
- 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: Primary clinical
Who may be able to join
None listed.
Who cannot join
- Cognitively impaired patients who cannot give informed consent, including patients assigned a power of attorney for medical decisions.
- Inability to communicate in the English language.
- Pre- existing or active psychiatric or neurologic impairments, not caused by the brain metastasis, which, in the opinion of the investigators, will interfere with the proper administration or completion of the protocol.
- Prior Therapy
- Patients must not have been treated for a previous brain metastasis.
- Patients must not have had previous cranial radiation.
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- Patients must not undergo treatment with an investigational drug for the primary disease within 7 days of baseline neuropsychological testing.
- Patients must not receive systemic therapy within 7 days prior to baseline neuropsychological testing.
- Patients who have had surgery for their current brain metastasis must wait at least 7 days before baseline neuropsychological testing.
- Concurrent Therapy
- Treatment of primary malignancy with systemic therapy (chemotherapy or biologic agents) cannot be delivered concurrently with the treatment of the intracranial disease. However, treatment of the primary site with local therapy, either surgery or radiotherapy, can be performed concurrently with the treatment of the intracranial disease.
- Patients receiving glucocorticoids should be tapered to the lowest possible dose, or stopped altogether, by the treating physician. If glucocorticoid dose is adjusted or given for the first time, the patient must remain on stable dose of glucocorticoids for at least 24 hours prior to initial neurocognitive testing, CT and MR imaging.
- Patients needing emergent radiation therapy for their brain metastases will be excluded.
- Patients must not have evidence of leptomeningeal metastases.
- Patients must not be HIV positive.
- Other medical conditions deemed by the PI or associates to make the patient ineligible for protocol investigations.
- Pregnant or breast-feeding females are excluded because of the potential mutagenic effects on a developing fetus or newborn.
- Clinically significant unrelated systemic illness which in the judgment of the Principal or Associate Investigator would compromise the patient s ability to tolerate this therapy or are likely to interfere with the study procedures or results.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: A Pilot Study to Evaluate Neuropsychological Outcome Measures and Their Relationship With Prognosis in Patients Receiving Radiation Therapy for Brain Metastases
Background:
- There are no standardized sets of tests to measure changes in neuropsychological functioning in patients treated for brain metastasis (cancer that has spread beyond the original site to the brain).
- Neuropsychological function has an important effect on quality of life and should be included when determining treatment options.
Read more
Objectives:
- To find out if there is a change in patients cognitive (thinking) and daily functioning after standard radiation treatment for brain metastasis that can be measured with tests.
- To see if any changes on these tests are related to patients response to radiation therapy.
Eligibility:
- Patients 18 years of age or older who have cancer that has spread to the brain.
Design:
- Patients receive a 2-week course of radiation therapy to the brain, given daily 5 days a week. Some patients may require stereotactic radiosurgery (an additional boost of radiation therapy to specific sites of brain metastasis).
- Patients have the following evaluations before and after treatment to determine changes in cognition and functioning:
- Neuropsychological testing to measure cognitive (thinking) abilities like memory, attention, processing speed, and reading, and fine motor skills.
- Questionnaires to assess quality of life and daily living skills.
- Patients have MRI scans and blood and urine tests.
- At the completion of radiation treatment, patients return to the clinic for follow-up visits at 1, 2, 4, 6, 9 and 12 months for blood and urine tests, physical examination, MRI of the brain, neuropsychological testing and assessments of quality of life and daily living skills.
Read the detailed description
Background:
- Metastatic brain tumors occur more frequently than primary brain tumors and occur in approximately 25 percent of patients who die of cancer each year.
- The Radiation Therapy Oncology Group (RTOG) developed three prognostic classes using a recursive partitioning analysis (RPA) of a large database. These classes are based on Karnofsky Performance Status (KPS), age and disease status.
- The RTOG RPA classes do not include neuropsychological function as a measure of outcome.
- There is no consensus of standardization of test selection to measure changes in neuropsychological functioning in this patient population.
- Neuropsychological function has an important effect on quality of life and should be included when determining prognosis and treatment options for patients.
- Neuropsychological functioning is important when determining the effects of treatments and for measuring outcomes in clinical trials.
Objectives:
- To identify the neuropsychological test scores which detect significant change in neuropsychological functioning in patients receiving radiation therapy for brain metastases.
- To examine the relationship between neuropsychological function and survival in patients receiving radiation therapy for brain metastases.
Eligibility:
- Patients aged 18 years and older.
- Pathologically confirmed primary malignancy with at least one intraparenchymal brain metastasis as identified on brain MRI scan with intravenous contrast.
- The patient must communicate in English in order to complete the neuropsychological evaluations.
Design:
- This is a longitudinal study that will administer serial neuropsychological assessments to patients with brain metastases who receive radiation therapy.
- Patients will undergo a battery of neuropsychological tests prior to radiotherapy (WBRT or WBRT followed by SRS), 2 weeks after completion of radiation therapy, then every 3 months for up to 12 months.
- The test battery will involve approximately 40 minutes of direct cognitive testing and 15 minutes of questionnaires.
There will be three cohorts of 20 patients each for a total of 60 patients. The three cohorts will be made up of differing histologies and will be sorted on the basis of their RTOG RPA Class.
- Conditions
- Brain Metastasis, Cancer
- Keywords
- Cancer, Radiation, Brain, Neuropsychological Outcome, Metastasis, Natural History, Brain Metastasis
- Medical subject headings
- Brain Neoplasms, Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1/Cohort 1 | KPS>70; Age =65; controlled primary tumor and no extracranial metastases | |
| 2/Cohort 2 | KPS>70 and at least one of the following: age >65, uncontrolled or synchronous primary disease, or extracranial metastases | |
| 3/Cohort 3 | KPS<70 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological function
To examine the relationship between neuropsychological function and survival in patients receiving radiation therapy for brain metastases
Measured: Completion of study
Test scores for: Hopkins Vrbl Learning Test recall; WAIS-III Digit Span; the WAIS-III Symbol Search; the Ruff 2 & 7 Selective Attn. The Trailmaking Tst Part B speed z-score; and the Grooved Pegboard Test dominant hand z-score
To identify the neuropsychological test scores which detect significant change in neuropsychological functioning in patients receiving radiation therapy for brain metastases
Measured: Completion of study
Secondary outcomes (7)
Strengths and weaknesses in neuropsychological functioning
To examine the strengths and weaknesses in neuropsychological functioning of patients with brain metastases after radiation therapy
Measured: completion of study
RTOG RPA classification
To examine the relationship between the RTOG RPA classification for brain metastasis survival and baseline neuropsychological functioning
Measured: completion of study
North American Adult Reading Test-Short Form (NART-35), Hopkins Verbal Learning Test (HVLT), WAIS-III Digit Span subtest, WAIS-III Symbol Search subtest, Ruff 2 and 7 Selective Attention Test
To further examine whether other measures from the following battery detect significant change in neuropsychological function or predict prognosis in this patient population
Measured: completion of study
Neuropsychological functioning, brain lesions (e.g., number and volume), MRI abnormalities, biomarkers, and disease progression or recurrence
To investigate the relationship between neuropsychological functioning, brain lesions (e.g., number and volume), MRI abnormalities, biomarkers, and disease progression or recurrence
Measured: completion of study
Neuropsychological functioning
To explore the neuropsychological functioning of patients with brain metastases treated with different therapies (e.g. chemotherapy, corticosteroids, complete surgical resection)
Measured: completion of study
neuron specific enolase (NSE), S100B, MMPs and VEGF
To investigate the role of biomarkers, including neuron specific enolase (NSE), S100B, MMPs and VEGF as potential markers of brain injury and disease progression in the serum, plasma and urine of patients with brain metastases
Measured: completion of study
Baseline neuropsychological data
To gather baseline neuropsychological data on patients with brain metastases for use as a reference in the development of new clinical trials involving this patient population in the ROB
Measured: completion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2011 (estimated)
- Study start17 Apr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Brain MetastasisStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- DeeDee K Smart, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445483
- Sponsor's protocol ID
- 080214
- Other IDs
- 08-C-0214
- Status last verified
- 14 Jul 2026
- First submitted
- 30 Sep 2011
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request.
Publications
Johnson JD, Young B. Demographics of brain metastasis. Neurosurg Clin N Am. 1996 Jul;7(3):337-44.
PubMed 8823767Posner JB. Management of brain metastases. Rev Neurol (Paris). 1992;148(6-7):477-87.
PubMed 1448668Wen PY, Loeffler JS. Brain metastases. Curr Treat Options Oncol. 2000 Dec;1(5):447-58. doi: 10.1007/s11864-000-0072-3.
PubMed 12057152
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate Neuropsychological Outcome Measures and Their Relationship With Prognosis in Patients Receiving Radiation Therapy for Brain Metastases
- ClinicalTrials.gov ID
- NCT01445483
- Acronym / sponsor ID
- 080214
- Conditions
- Brain Metastasis, Cancer
- Keywords
- Cancer, Radiation, Brain, Neuropsychological Outcome, Metastasis, Natural History, Brain Metastasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 17 Apr 2009 (actual)
- First posted
- 3 Oct 2011 (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.
Background:
- There are no standardized sets of tests to measure changes in neuropsychological functioning in patients treated for brain metastasis (cancer that has spread beyond the original site to the brain).
- Neuropsychological function has an important effect on quality of life and should be included when determining treatment options.
Objectives:
- To find out if there is a change in patients cognitive (thinking) and daily functioning after standard radiation treatment for brain metastasis that can be measured with tests.
- To see if any changes on these tests are related to patients response to radiation therapy.
Eligibility:
- Patients 18 years of age or older who have cancer that has spread to the brain.
Design:
- Patients receive a 2-week course of radiation therapy to the brain, given daily 5 days a week. Some patients may require stereotactic radiosurgery (an additional boost of radiation therapy to specific sites of brain metastasis).
- Patients have the following evaluations before and after treatment to determine changes in cognition and functioning:
- Neuropsychological testing to measure cognitive (thinking) abilities like memory, attention, processing speed, and reading, and fine motor skills.
- Questionnaires to assess quality of life and daily living skills.
- Patients have MRI scans and blood and urine tests.
- At the completion of radiation treatment, patients return to the clinic for follow-up visits at 1, 2, 4, 6, 9 and 12 months for blood and urine tests, physical examination, MRI of the brain, neuropsychological testing and assessments of quality of life and daily living skills.
Detailed description
Background:
- Metastatic brain tumors occur more frequently than primary brain tumors and occur in approximately 25 percent of patients who die of cancer each year.
- The Radiation Therapy Oncology Group (RTOG) developed three prognostic classes using a recursive partitioning analysis (RPA) of a large database. These classes are based on Karnofsky Performance Status (KPS), age and disease status.
- The RTOG RPA classes do not include neuropsychological function as a measure of outcome.
- There is no consensus of standardization of test selection to measure changes in neuropsychological functioning in this patient population.
- Neuropsychological function has an important effect on quality of life and should be included when determining prognosis and treatment options for patients.
- Neuropsychological functioning is important when determining the effects of treatments and for measuring outcomes in clinical trials.
Objectives:
- To identify the neuropsychological test scores which detect significant change in neuropsychological functioning in patients receiving radiation therapy for brain metastases.
- To examine the relationship between neuropsychological function and survival in patients receiving radiation therapy for brain metastases.
Eligibility:
- Patients aged 18 years and older.
- Pathologically confirmed primary malignancy with at least one intraparenchymal brain metastasis as identified on brain MRI scan with intravenous contrast.
- The patient must communicate in English in order to complete the neuropsychological evaluations.
Design:
- This is a longitudinal study that will administer serial neuropsychological assessments to patients with brain metastases who receive radiation therapy.
- Patients will undergo a battery of neuropsychological tests prior to radiotherapy (WBRT or WBRT followed by SRS), 2 weeks after completion of radiation therapy, then every 3 months for up to 12 months.
- The test battery will involve approximately 40 minutes of direct cognitive testing and 15 minutes of questionnaires.
There will be three cohorts of 20 patients each for a total of 60 patients. The three cohorts will be made up of differing histologies and will be sorted on the basis of their RTOG RPA Class.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1/Cohort 1 | – | –KPS>70; Age =65; controlled primary tumor and no extracranial metastases |
| 2/Cohort 2 | – | –KPS>70 and at least one of the following: age >65, uncontrolled or synchronous primary disease, or extracranial metastases |
| 3/Cohort 3 | – | –KPS<70 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary clinical
Key inclusion criteria (0 listed)
Key exclusion criteria (18 listed)
- Cognitively impaired patients who cannot give informed consent, including patients assigned a power of attorney for medical decisions.
- Inability to communicate in the English language.
- Pre- existing or active psychiatric or neurologic impairments, not caused by the brain metastasis, which, in the opinion of the investigators, will interfere with the proper administration or completion of the protocol.
- Prior Therapy
- Concurrent Therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neuropsychological function
Time frame: Completion of study
To examine the relationship between neuropsychological function and survival in patients receiving radiation therapy for brain metastases
Test scores for: Hopkins Vrbl Learning Test recall; WAIS-III Digit Span; the WAIS-III Symbol Search; the Ruff 2 & 7 Selective Attn. The Trailmaking Tst Part B speed z-score; and the Grooved Pegboard Test dominant hand z-score
Time frame: Completion of study
To identify the neuropsychological test scores which detect significant change in neuropsychological functioning in patients receiving radiation therapy for brain metastases
7 secondary outcomes
Strengths and weaknesses in neuropsychological functioning
Time frame: completion of study
RTOG RPA classification
Time frame: completion of study
North American Adult Reading Test-Short Form (NART-35), Hopkins Verbal Learning Test (HVLT), WAIS-III Digit Span subtest, WAIS-III Symbol Search subtest, Ruff 2 and 7 Selective Attention Test
Time frame: completion of study
Neuropsychological functioning, brain lesions (e.g., number and volume), MRI abnormalities, biomarkers, and disease progression or recurrence
Time frame: completion of study
Neuropsychological functioning
Time frame: completion of study
neuron specific enolase (NSE), S100B, MMPs and VEGF
Time frame: completion of study
Baseline neuropsychological data
Time frame: completion of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 8823767Johnson JD, Young B. Demographics of brain metastasis. Neurosurg Clin N Am. 1996 Jul;7(3):337-44.
- Background: PubMed 1448668Posner JB. Management of brain metastases. Rev Neurol (Paris). 1992;148(6-7):477-87.
- Background: PubMed 12057152Wen PY, Loeffler JS. Brain metastases. Curr Treat Options Oncol. 2000 Dec;1(5):447-58. doi: 10.1007/s11864-000-0072-3.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request.
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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.
DeeDee K Smart, M.D. principal investigator
National Cancer Institute (NCI)
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 Brain Metastasis and Cancer, run by National Cancer Institute (NCI) 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 0 inclusion and 18 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: finished, as of the sponsor's last update on 29 Oct 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Neuropsychological function (time frame: Completion of study). 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?
On the ClinicalTrials.gov record for NCT01445483, which also lists 3 linked publications.
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 29 Oct 2026.