NCT03184038

Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery

Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery: A Phase II Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Malignant Neoplasm in the Brain
• Metastatic Malignant Solid Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Cognitive Assessment	Undergo assessment of neurocognitive function
RADIATION	Stereotactic Radiosurgery	Undergo SRS
RADIATION	Stereotactic Body Radiation Therapy	Undergo SBRT
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

• Start date: 2017-02-21
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2017-06-12
• Last updated: 2025-05-15

Locations

2 sites across 1 country: United States