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Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery: A Phase II Study
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.
PRIMARY OBJECTIVES: I. Assessment of neurocognitive function at months 4. SECONDARY OBJECTIVES: I. Assessment of neurocognitive function at months 4 and 12 as measured by neurocognitive decline on a battery of tests. II. Assessment of symptom burden, as measured by the M.D. Anderson Symptom Inventory- Brain Tumor Module (MDASI-BT). III. Assessment of quality adjusted survival and health outcomes using the European Quality of Life Five Dimension Five Level scale questionnaire (EQ-5D-5L). IV. Assessment of local control, in brain control. V. Assessment of progression free survival (PFS), and overall survival (OS). VI. Assessment of side effects and toxicities. OUTLINE: Patients 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. After completion of study, patients are followed up at 2, 4, 6, 8, 10, and 12 months.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Jefferson Health New Jersey
Sewell, New Jersey, United States
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Start Date
February 21, 2017
Primary Completion Date
September 30, 2026
Completion Date
September 30, 2026
Last Updated
May 15, 2025
90
ESTIMATED participants
Cognitive Assessment
PROCEDURE
Stereotactic Radiosurgery
RADIATION
Stereotactic Body Radiation Therapy
RADIATION
Quality-of-Life Assessment
OTHER
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
NCT05372640
NCT04704661
Data Source & Attribution
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