Cognitive Outcome After Gamma Knife Radiosurgery in Patients With Brain Metastases (CAR-Study A)
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|ClinicalTrials.gov Identifier: NCT02953756|
Recruitment Status : Completed
First Posted : November 3, 2016
Last Update Posted : August 14, 2020
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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).
|Condition or disease||Intervention/treatment|
|Neoplasm Metastases||Radiation: Gamma Knife radiosurgery|
|Study Type :||Observational|
|Actual Enrollment :||92 participants|
|Official Title:||Cognitive Outcome After Gamma Knife Radiosurgery in Patients With 1-10 Brain Metastases|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||October 2019|
|Actual Study Completion Date :||October 2019|
Stereotactic radiosurgery (SRS)
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 [ Time Frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS ]Verbal memory is measured with the Hopkins Verbal Learning Test-Revised (HVLT-R)
- Change in cognitive flexibility [ Time Frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS ]Cognitive flexibility is measured with the Trail Making Test B (TMT B)
- Change in word fluency [ Time Frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS ]Word Fluency is measured with the Controlled Oral Word Association (COWA)
- Change in working memory [ Time Frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS ]Working memory is measured with the Wechsler Adult Intelligence Scale - Digit Span
- Change in processing speed [ Time Frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS ]Processing speed is measured with the Wechsler Adult Intelligence Scale - Digit Symbol
- Change in motor dexterity [ Time Frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS ]Motor dexterity is measured with the Grooved Pegboard (GP)
- Health Related Quality Of Life (HRQOL) [ Time Frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS ]The Functional Assessment of Cancer Therapy-Brain (FACT-Br) is used to measure HRQOL.
- Fatigue [ Time Frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS ]Fatigue is measured with the Multidimensional Fatigue Inventory (MFI).
- Depression and anxiety [ Time Frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS. ]Depression and anxiety are measured with the Hospital Anxiety and Depression Scale (HADS).
- Median Overall Survival [ Time Frame: 12 months after GKRS ]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.
- Local tumor control [ Time Frame: 12 months after GKRS ]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.
- Distant tumor control [ Time Frame: 12 months after GKRS ]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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Histologically proven malignant cancer
- 1-10 newly diagnosed brain metastases on a triple dose gadolinium-enhanced MRI-scan
- Maximum total tumor volume 30 cm3
- Lesion ≥ 3 mm from the optic apparatus
- Age ≥ 18 years
- Karnofsky Performance Status (KPS) ≥ 70
- Anticipated survival > 3 months
- No prior histologic confirmation of malignancy
- Primary brain tumor
- A second active primary tumor
- Small cell lung cancer
- Meningeal disease
- Progressive, symptomatic systemic disease without further treatment options
- Prior brain radiation
- Prior surgical resection of brain metastases
- 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
- Contra indications to MRI or gadolinium contrast
- Underlying medical condition precluding adequate follow-up
- Lack of basic proficiency in Dutch
- IQ below 85
- Severe aphasia
- Paralysis grade 0-3 according to MRC scale (Medical Research Council)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02953756
|Gamma Knife Center Tilburg, Elisabeth-TweeSteden Hospital|
|Tilburg, Noord-Brabant, Netherlands, 5022 GC|
|Principal Investigator:||Patrick EJ Hanssens, MD||Gamma Knife Center Tilburg, Elisabeth-TweeSteden Hospital, The Netherlands|
|Responsible Party:||Elisabeth-TweeSteden Ziekenhuis|
|Other Study ID Numbers:||
|First Posted:||November 3, 2016 Key Record Dates|
|Last Update Posted:||August 14, 2020|
|Last Verified:||February 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
Gamma Knife Radiosurgery
Quality of Life
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Central Nervous System Diseases
Nervous System Diseases