Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery

This study is looking at how two types of radiation therapy, Stereotactic Radiosurgery (SRS) and Stereotactic Body Radiation Therapy (SBRT), affect brain function (neurocognition) in people with multiple brain tumors that have spread from other parts of the body (metastatic malignant neoplasm in the brain). Researchers want to see if SRS helps preserve brain function better than SBRT. You might be able to join if you are 18 or older, have 1 to 10 brain metastases from a solid tumor (not small cell lung cancer or germ cell tumor), and meet other health criteria. The study aims to measure changes in your brain function at 4 months after treatment. The current status of this study is unclear, and it plans to enroll 90 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 90 participants, but the phase is not specified.
What's involved
You would undergo cognitive assessments, receive either SRS or SBRT, and have quality-of-life assessments. Neurocognitive testing will occur at baseline, 4, and 12 months after treatment.
Compensation
Not stated in the trial record.
Follow-up
After treatment, participants are followed up at 2, 4, 6, 8, 10, and 12 months.

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NCT03184038

Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery

Recruiting
NAAges 18+InterventionalTreatment
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
~90 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Cognitive AssessmentStereotactic RadiosurgeryStereotactic Body Radiation TherapyQuality-of-Life Assessment

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Neurocognitive function as measured by neurocognitive decline on a battery of tests
Measured over At 4 months
Metastatic Malignant Neoplasm in the Brain
Metastatic Malignant Solid Neoplasm
2 sites across 2 states
New Jersey1
Pennsylvania1
  • Wenyin Shi, MD · PRINCIPAL_INVESTIGATOR · Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

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Eligibility criteria

Inclusion

Pathologically proven solid tumor malignancy (except for small cell lung cancer \[SCLC\], germ cell tumor)
Karnofsky performance status \>= 60
1 to 10 brain metastases (mets) (no more than two lesions and/or cavities \>= 3 cm in maximum diameter)
Maximum diameter of brain metastasis or resection cavity is 6 cm
Serum creatinine =\< 3 mg/dL and creatinine clearance \>= 30 ml/min
Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up; patients must be willing to complete neurocognitive assessments at pre-specified time points outlined in the protocol
Women of childbearing potential must have a negative beta-human chorionic gonadotropin (HCG) pregnancy test documented within 21 days prior to registration
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 4 months after last dose
Patient able to provide his/her own written informed consent and speak English

Exclusion

Patient with diagnosis of glioma, or other World Health Organization (WHO) grade II - IV primary brain tumor
Prior brain surgery =\< 14 days prior to enrollment
Planned chemotherapy during radiosurgery
Leptomeningeal metastases
Intractable seizures while on adequate anticonvulsant therapy-more than 1 seizure per week for the past 2 months
Pregnant women
  • Neurocognitive function as measured by neurocognitive decline on a battery of testsAt 4 months

    The proportion of patients with neurocognitive decline at 4 months post stereotactic radiosurgery (SRS) treatment in each group will be estimated using the sample proportion with the corresponding two-sided 95% confidence interval. The determination of neurocognitive decline will be based on a battery of tests: Hopkins Verbal Learning Test-Revised (HVLT-R) for Total Recall, Delayed Recall, and Delayed Recognition, Controlled Oral Word Association (COWA), and the Trail Making Test (TMT) Parts A and B. The operative definition for neurocognitive decline in this study will be decline on at least one of these measures.