CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 35 enrolled / 35 target
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01445483
NCT01445483N/ACompletedUpdate Overdue (0.2/mo)

A Pilot Study to Evaluate Neuropsychological Outcome Measures and Their Relationship With Prognosis in Patients Receiving Radiation Therapy for Brain Metastases

National Cancer Institute (NCI)·observational·Posted Oct 3, 2011·Updated Jun 30, 2026

In Brief

An observational study for Brain Metastasis and Cancer. Completed, enrolled 35 participants across 1 site.

Signals

Enrollment appears stalled

Detailed 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). * 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 3, 2011
Enrollment StartApr 17, 2009
TodayJul 2, 2026
Posted 14.7 years ago

Arms & Interventions

1/Cohort 1other

KPS\>70; Age =65; controlled primary tumor and no extracranial metastases

2/Cohort 2other

KPS\>70 and at least one of the following: age \>65, uncontrolled or synchronous primary disease, or extracranial metastases

3/Cohort 3other

KPS\<70