Cognitive outcome after Gamma Knife Radiosurgery in patients with brain metastases

Completed

• Conditions: cognitieve stoornissen; Brain metastases; brain tumor; 10027476; 10029211

• Registration Number: NL-OMON43670
• Lead Sponsor: Sint Elisabeth Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-10-07
• Results First Posted: 2019-10-08
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 101

Inclusion Criteria

* Contrast enhanced volumetric MRI showing 1-10 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
Dutch healthy control subjects will be:
* Sociodemographically similar to the patient group
* In good health, with no current or past psychiatric, neurologic, or cognitive disorder, and mediation-use that interferes with cognitive function

Exclusion Criteria

* No prior histologic confirmation of malignancy
* Primary brain tumor, small cell lung cancer, lymphoma, 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: Observational non invasive
• 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>