Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery
2 other identifiers
interventional
90
1 country
2
Brief Summary
This phase II trial studies the neurological function in patients with multiple brain metastases undergoing stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Assessment of neurocognitive function may help show that SRS preserves neurological function in patients with multiple brain metastases better than SBRT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2017
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 21, 2017
CompletedFirst Submitted
Initial submission to the registry
April 5, 2017
CompletedFirst Posted
Study publicly available on registry
June 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2026
May 15, 2025
May 1, 2025
9.6 years
April 5, 2017
May 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Neurocognitive function as measured by neurocognitive decline on a battery of tests
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.
At 4 months
Secondary Outcomes (7)
Change in neurocognitive function as measured by neurocognitive decline on a battery of tests conducted by the primary investigator or a trained member of the clinical team
Baseline to up to 12 months
Change in symptom burden as measured by the MD Anderson Symptom Inventory- Brain Tumor Module (MDASI-BT)
Baseline to up to 12 months
Quality adjusted survival and health outcomes as measured by the European Quality of Life Five Dimension Five Level scale questionnaire (EQ-5D-5L)
Up to 12 months
Local control as measured by magnetic resonance imaging
Up to 12 months
Progression free survival (PFS)
Up to 12 months
- +2 more secondary outcomes
Study Arms (1)
Supportive care (SRS/SBRT, neurocognitive testing)
EXPERIMENTALPatients undergo SRS on day 1 or SBRT for 3 fractions over days 1-7 and undergo neurocognitive testing at baseline, 4, and 12 months after undergoing SRS or SBRT.
Interventions
Undergo assessment of neurocognitive function
Undergo SRS
Undergo SBRT
Ancillary studies
Eligibility Criteria
You may qualify if:
- Pathologically proven solid tumor malignancy (except for small cell lung cancer \[SCLC\], germ cell tumor)
- Karnofsky performance status \>= 60
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Jefferson Health New Jersey
Sewell, New Jersey, 08080, United States
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wenyin Shi, MD
Sidney Kimmel Cancer Center at Thomas Jefferson University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2017
First Posted
June 12, 2017
Study Start
February 21, 2017
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2026
Last Updated
May 15, 2025
Record last verified: 2025-05