Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery: A Phase II Study
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
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.
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), a…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 neurocogniti…
Interventions
- ProcedureCognitive Assessment
Undergo assessment of neurocognitive function
- RadiationStereotactic Radiosurgery
Undergo SRS
- RadiationStereotactic Body Radiation Therapy
Undergo SBRT
- OtherQuality-of-Life Assessment
Ancillary studies
Locations (2)
- Jefferson Health New JerseySewell, New Jersey
- Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhiladelphia, Pennsylvania