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Brief Title: Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery
Official Title: Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery: A Phase II Study
Study ID: NCT03184038
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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Aria Health, Philadelphia, Pennsylvania, United States
Reading Hospital, Reading, Pennsylvania, United States
Name: Wenyin Shi, MD
Affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
Role: PRINCIPAL_INVESTIGATOR