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| Name | Class |
|---|---|
| Tilburg University | OTHER |
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic radiosurgery (SRS) | Gamma Knife radiosurgery (GKRS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gamma Knife radiosurgery | Radiation | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in verbal memory | Verbal memory is measured with the Hopkins Verbal Learning Test-Revised (HVLT-R) | 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) | 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) | 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 | 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 | 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) | Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS |
| Measure | Description | Time Frame |
|---|---|---|
| Health Related Quality Of Life (HRQOL) | The Functional Assessment of Cancer Therapy-Brain (FACT-Br) is used to measure HRQOL. | Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS |
| Fatigue | Fatigue is measured with the Multidimensional Fatigue Inventory (MFI). |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Patrick EJ Hanssens, MD | Gamma Knife Center Tilburg, Elisabeth-TweeSteden Hospital, The Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gamma Knife Center Tilburg, Elisabeth-TweeSteden Hospital | Tilburg | North Brabant | 5022 GC | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37249646 | Derived | Verhaak E, Schimmel WCM, Sitskoorn MM, Hanssens PEJ, Butterbrod E, Gehring K. The long-term course and relationship with survival of multidimensional fatigue in patients with brain metastases after Gamma Knife radiosurgery. J Cancer Res Clin Oncol. 2023 Sep;149(12):9891-9901. doi: 10.1007/s00432-023-04857-1. Epub 2023 May 30. | |
| 33025282 |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D001932 | Brain Neoplasms |
| D005221 | Fatigue |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| 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). | 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. | 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. | 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. | 12 months after GKRS |
| Verhaak E, Schimmel WCM, Gehring K, Emons WHM, Hanssens PEJ, Sitskoorn MM. Health-related quality of life after Gamma Knife radiosurgery in patients with 1-10 brain metastases. J Cancer Res Clin Oncol. 2021 Apr;147(4):1157-1167. doi: 10.1007/s00432-020-03400-w. Epub 2020 Oct 6. |
| 31552588 | Derived | Schimmel WCM, Gehring K, Hanssens PEJ, Sitskoorn MM. Cognitive functioning and predictors thereof in patients with 1-10 brain metastases selected for stereotactic radiosurgery. J Neurooncol. 2019 Nov;145(2):265-276. doi: 10.1007/s11060-019-03292-y. Epub 2019 Sep 24. |
| 31342318 | Derived | Butterbrod E, Bruijn J, Braaksma MM, Rutten GM, Tijssen CC, Hanse MCJ, Sitskoorn MM, Gehring K. Predicting disease progression in high-grade glioma with neuropsychological parameters: the value of personalized longitudinal assessment. J Neurooncol. 2019 Sep;144(3):511-518. doi: 10.1007/s11060-019-03249-1. Epub 2019 Jul 24. |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |