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New study measures how brain radiation affects thinking and daily life

NCT ID NCT01445483

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 20 times

Summary

This study looked at whether standard radiation treatment for cancer that has spread to the brain causes changes in thinking skills like memory and attention. 35 adults with brain metastases received radiation and took tests and surveys before and after treatment. The goal was to find better ways to measure these changes and see if they relate to how well patients do overall.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

35 people

The number who actually took part.

Started

Apr 2009

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Primary clinical

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

-INCLUSION CRITERIA: 1. Patients must be 18 years of age or older. 2. Pathologically confirmed primary malignancy with at least one intraparenchymal brain metastasis as identified on brain MRI scan with intravenous contrast. * Cohort 1 (N=20): KPS greater than 70; Age less than or equal to 65; controlled primary tumor and no extracranial metastases. * Cohort 2 (N=20): KPS greater than 70 and at least one of the following: age greater than 65, uncontrolled or synchronous primary disease, or extracranial metastases * Cohort 3 (N=20): KPS less than 70 3. Patient must have a primary medical or surgical oncologist in the community or at NCI who is willing to collaborate with the ROB staff in the clinical management of the patient. 4. All patients must sign a document of informed consent indicating their understanding of the investigational nature and the risks of this study BEFORE any of the protocol related studies are preformed (this does not include routine laboratory tests or imaging studies required to establish eligibility). 5. Subjects of childbearing or child- fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while they are being treated on this study. EXCLUSION CRITERIA: 1. Cognitively impaired patients who cannot give informed consent, including patients assigned a power of attorney for medical decisions. 2. Inability to communicate in the English language. 3. 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. 4. Prior Therapy * Patients must not have been treated for a previous brain metastasis. * Patients must not have had previous cranial radiation. * 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. 5. 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. 6. Patients needing emergent radiation therapy for their brain metastases will be excluded. 7. Patients must not have evidence of leptomeningeal metastases. 8. Patients must not be HIV positive. 9. Other medical conditions deemed by the PI or associates to make the patient ineligible for protocol investigations. 10. Pregnant or breast-feeding females are excluded because of the potential mutagenic effects on a developing fetus or newborn. 11. 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.