A Prospective Randomized Study to Compare Neurocognitive Outcome after Gamma Knife Radiosurgery or Whole Brain Radiation Therapy for the Treatment of Multiple Brain Metastases
Recruiting
- Conditions
- Brain metastases
- Registration Number
- NL-OMON28765
- Lead Sponsor
- St Elisabeth Hospital, Tilburg and Tilburg University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
• Histologically proven malignant cancer
• Imaging and clinical presentation consistent with BM; contrast enhanced volumetric MRI used for treatment planning showing 11-20 newly diagnosed BM with a maximum total tumor volume of 30 cm3
Exclusion Criteria
• No prior histologic confirmation of malignancy
• Primary brain tumor, a second (active) primary tumor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The definition of the primary endpoint is the statistically significant difference in the percentage of patients with significant cognitive decline at three months between treatment groups. Decline is defined as a 5-point decrease from baseline based on the reliable change index (with correction for practice effects) in HVLT-R Total Recall score.
- Secondary Outcome Measures
Name Time Method