A prospective randomized study to compare neurocognitive outcome after Stereotactic Radiosurgery or Whole Brain Radiation Therapy for the treatment of multiple brain metastases
- Conditions
- cognitieve stoornissenBrain metastasesbrain tumor1002747610029211
- Registration Number
- NL-OMON55790
- Lead Sponsor
- Sint Elisabeth Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
• Contrast enhanced volumetric MRI-scan showing 11-20 newly diagnosed BM with a
total tumor volume <= 30cc
• Lesion > 3 mm from optic apparatus*
• Patient age >= 18 years*
• Karnofsky Performance Status >= 70, WHO performance status <= 2*
• Anticipated survival (independent of the BM) greater than 3 months
• No prior histologic confirmation of malignancy
• Primary brain tumor, lymphoma, small cell lung cancer, leukemia, or meningeal
disease
• Progressive, symptomatic systemic disease without further treatment options
• Prior brain radiation or surgical resection of BM
• Additional history of a significant neurological or psychiatric disorder
• Participation in a concurrent study in which neuropsychological testing
and/or health-related QOL assessments are involved
• Patients unable to complete test battery and/or study questionnaires due to
any of the following reasons: lack of basic proficiency in Dutch, IQ below 85,
severe aphasia, or paralysis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Cognitive functioning as assessed with a battery of neuropsychological tests:<br /><br>The revised Hopkins Verbal Learning Test (HVLT-R), WAIS Digit Span and Digit<br /><br>Symbol, TMT A and B, COWA, and Grooved Pegboard </p><br>
- Secondary Outcome Measures
Name Time Method <p>• Fatigue (MFI)<br /><br>• Health related QOL (FACT-BR)<br /><br>• Depression and anxiety (HADS)<br /><br>• Overall Survival<br /><br>• Local and distant tumor control</p><br>