Assessment of Neurocognitive Function in Patients With Multiple Brain Metastases Undergoing Stereotactic Radiosurgery or Stereotactic Body Radiation Therapy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 360
Summary
- Conditions
- Metastatic Malignant Neoplasm in the Brain
- Solid Neoplasm
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. Assessment of neurocognitive function at months 4. SECONDARY OBJECTIVES: I. Assessment of neurocognitive function at months 2, 6, 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 Inve...
PRIMARY OBJECTIVES: I. Assessment of neurocognitive function at months 4. SECONDARY OBJECTIVES: I. Assessment of neurocognitive function at months 2, 6, 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.
Tracking Information
- NCT #
- NCT03184038
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Wenyin Shi, MD Sidney Kimmel Cancer Center at Thomas Jefferson University
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