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|NCT01445483 : Neuropsychological Changes in Patients Receiving Radiation Therapy for Brain Metastases|
|Ages||Min: 18 Years Max: 90 Years|
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
- 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
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.
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
- 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
- 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
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.
|Links||Permanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT01445483
| Link to official Clinicaltrials.gov listing
Facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office Phone: (888) NCI-1937
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