An observational study in Neoplasm Metastases, sponsored by Elisabeth-TweeSteden Ziekenhuis. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-14.
Sponsored by Elisabeth-TweeSteden Ziekenhuis · Observational
Stereotactic radiosurgery (SRS) is increasingly applied in patients with brain metastases (BM) and is expected to have less adverse effects on cognitive functioning than Whole Brain Radiation Therapy (WBRT). Because cognitive functions are essential for daily functioning, and may affect therapy compliance and quality of life in general, a full understanding of cognitive functioning in patients with BM after SRS is essential.
CAR-Study A is a prospective study to evaluate cognitive functioning in patients with 1-10 BM accepted for treatment with Gamma Knife radiosurgery (GKRS).
CAR-Study A is a prospective study to evaluate cognitive functioning after GKRS in patients with 1-10 newly diagnosed brain metastases on a triple dose gadolinium-enhanced MRI-scan. Neuropsychological assessment will be performed at baseline and at 3, 6, 9, 12, 15, and 21 months after treatment. Follow-up assessments will be combined with 3-monthly MRI-scans.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's enrollment of 92 is below the median of 121 across 594 observational studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Elisabeth-TweeSteden Ziekenhuis is the lead sponsor of 11 studies on the registry; none are open to participants now.
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Consecutive patients with 1-10 newly diagnosed brain metastases on a triple dose gadolinium-enhanced MRI-scan accepted for treatment with GKRS at the Gamma Knife Center Tilburg, The Netherlands.
Exclusion Criteria:
Gamma Knife radiosurgery (GKRS)
Radiation: Gamma Knife radiosurgery
Gamma Knife radiosurgery will be performed with a Leksell Gamma Knife® Icon, Elekta Instruments, AB. Depending upon the tumor volume, a dose of 18-25 Gy will be prescribed with 99-100% coverage of the target
Change in verbal memory
Verbal memory is measured with the Hopkins Verbal Learning Test-Revised (HVLT-R)
Time frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Change in cognitive flexibility
Cognitive flexibility is measured with the Trail Making Test B (TMT B)
Time frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Change in word fluency
Word Fluency is measured with the Controlled Oral Word Association (COWA)
Time frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Change in working memory
Working memory is measured with the Wechsler Adult Intelligence Scale - Digit Span
Time frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Change in processing speed
Processing speed is measured with the Wechsler Adult Intelligence Scale - Digit Symbol
Time frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Change in motor dexterity
Motor dexterity is measured with the Grooved Pegboard (GP)
Time frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Health Related Quality Of Life (HRQOL)
The Functional Assessment of Cancer Therapy-Brain (FACT-Br) is used to measure HRQOL.
Time frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Fatigue
Fatigue is measured with the Multidimensional Fatigue Inventory (MFI).
Time frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Depression and anxiety
Depression and anxiety are measured with the Hospital Anxiety and Depression Scale (HADS).
Time frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS.
Median Overall Survival
Overall survival is defined as the time in months from the start of GKRS to the date of death or last contact if alive. Kaplan-Meier methods are used to estimate overall survival.
Time frame: 12 months after GKRS
Local tumor control
Local brain tumor control of the initial GKRS-treated lesions is defined as a complete, partial, or stable response, or less than a 25% increase in diameter on contrast-enhanced MRI follow-up and not requiring resection. Any initial treated lesions increased by more than 25% in diameter on contrast-enhanced MRI or required resection will be considered a local failure.
Time frame: 12 months after GKRS
Distant tumor control
Distant brain tumor control is defined as the absence of any new brain metastases, distinct from the initial GKRS-treated lesion(s), on follow-up MRI. The appearance of one or more new lesions in the brain by contrast-enhanced follow-up MRI is considered distant failure.
Time frame: 12 months after GKRS
Plan to share: Undecided
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Elisabeth-TweeSteden Ziekenhuis