Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase II Trial of Hippocampal Avoidance During Whole Brain Radiotherapy for Brain Metastases
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells.
PURPOSE: This phase II trial is studying how well avoiding the hippocampus during whole-brain
radiation therapy works in treating patients with brain metastases.
OBJECTIVES:
Primary
- Evaluate delayed recall as assessed by the Hopkins Verbal Learning Test-Revised (HVLT-R)
at 4 months after hippocampal avoidance during whole-brain radiotherapy (HA-WBRT) in
patients with brain metastasis.
Secondary
- Evaluate auditory and visual learning and memory, as assessed by two CogState tests
(International Shopping List Test and One Card Learning Test), after HA-WBRT in these
patients.
- Compare psychometric properties of the 2 CogState tests to the HVLT-R for the assessment
of memory decline after HA-WBRT in these patients.
- Evaluate health-related quality of life [as assessed by the Functional Assessment of
Cancer Therapy with Brain Subscale (FACT-BR) and the Barthel Index of Activities of
Daily Living (ADLs)] after HA-WBRT in these patients.
- Evaluate time to radiographic progression after HA-WBRT in these patients.
- Evaluate overall survival of these patients after HA-WBR.
- Evaluate the adverse events of HA-WBR.
- Evaluate predictive biomarkers of cognitive function.
OUTLINE: This is a multicenter study.
Patients undergo 10 fractions of intensity-modulated whole-brain radiotherapy (WBRT),
avoiding hippocampal (HA) regions, once daily, 5 days a week, for 2-2½ weeks.
Patients neurocognitive functions (delayed recall, auditory and visual learning, and memory)
are evaluated by the Hopkins Verbal Learning Test-Revised (HVTL-R), The One Card Learning
Test (OCLT), and the International Shopping List Test (ISLT) at baseline and periodically
during study.
Patients may undergo serum, plasma, or whole blood collection at baseline and at 4 months
after completion of HA-WBRT for correlative studies.
Patients may complete the Functional Assessment of Cancer Therapy with Brain Subscale
(FACT-BR), and the Barthel Index of Activities of Daily Living (ADLs) quality-of-life
questionnaires at baseline and periodically during study and follow up.
After completion of study therapy, patients are followed up periodically.
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