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A Prospective Randomized Study to Compare Neurocognitive Outcome after Gamma Knife Radiosurgery or Whole Brain Radiation Therapy for the Treatment of Multiple Brain Metastases


- candidate number22871
- NTR NumberNTR5463
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-sep-2015
- Secondary IDs842003006; P1516 Project number ZonMw; Protocol ID MEC
- Public TitleA Prospective Randomized Study to Compare Neurocognitive Outcome after Gamma Knife Radiosurgery or Whole Brain Radiation Therapy for the Treatment of Multiple Brain Metastases
- Scientific TitleA Prospective Randomized Study to Compare Neurocognitive Outcome after Gamma Knife Radiosurgery or Whole Brain Radiation Therapy for the Treatment of Multiple Brain Metastases
- ACRONYMThe CAR study
- hypothesisEffective treatment for patients with brain metastases (BM) without negative cognitive side effects is increasingly becoming more important, since more patients survive and live longer after treatment. Ultimately, the purpose of this line of research is to inform individual patients with BM more precisely about the (long-term) cognitive effects and the consequences they can expect from treatment with either whole brain radiation therapy (WBRT) or Gamma Knife Radiosurgery (GKRS). This will enable patients and doctors to make a better informed treatment decision grounded on scientific evidence. This study aims to examine cognitive outcome and therefore QOL in patients with BM after WBRT or GKRS.
- Healt Condition(s) or Problem(s) studiedBrain metastases
- 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 diameter of 3.5 cm for the largest lesion and additional lesions not exceeding 3 cm in diameter
• Lesion >5mm from brainstem or optic apparatus
• Patient age >/=18 years
• Karnofsky Performance Status >/=70
• WHO performance status • Stable extracranial disease
• Anticipated survival (independent of the BM) greater than 3 months
• Patient informed consent obtained (verifying that patients are aware of the investigational nature of this study).
- Exclusion criteria• No prior histologic confirmation of malignancy
• Primary brain tumor
• Small cell lung cancer
• Leukemia
• Meningeal disease
• Lymphoma
• Progressive, symptomatic systemic disease without further treatment options
• Prior brain radiation
• Prior 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
• Contra indications to MRI or gadolinium contrast
• Underlying medical condition precluding adequate follow-up
• Lack of informed consent
• 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, paralysis grade 0-3 according to MRC scale (Medical Research Council)
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2015
- planned closingdate30-jun-2019
- Target number of participants80
- InterventionsPatients will complete a standardized battery of neuropsychological test both at baseline and 3, 6, 9, 12, and 15 months post GKRS or WBRT. Patients in the WBRT group will receive 4 Gy x 5 fractions (total of 20 Gy) in one week, which is a commonly utilized treatment schedule according to Dutch guidelines. GKRS will be performed with a (fully robotic) Leksell Gamma Knife® Perfexion, Elekta Instruments, AB. Depending upon the volume, a dose of 18-25 Gy will be prescribed with 99-100% coverage of the target.
- Primary outcomeThe 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• Differences in percentage of patients with a 5 or more point decrease in HVLT-R between treatment arms will be assessed at 6, 9, 12, and 15 months as is done for 3 months for the primary endpoint. We will assess both proportions at each time and the overall trend of change over time.
• Group mean scores for all neuropsychological tests will be determined for both treatment arms at baseline, 3, 6, 9, 12, and 15 months. We will assess both proportions at each time and the overall trend of change over time.
• Overall survival will be measured from the first day of treatment to date of death or last study follow-up (15 months).
• Local and distant brain tumor control of the initial GKRS- or WBRT-treated lesions is defined according to the RECIST Response Criteria. • Depression, anxiety, health related QOL and fatigue.
• Type and duration of systemic therapy and medication use will be recorded. The total number of cycles of systemic therapy will be calculated from either the day of treatment with GKRS or from the first day of WBRT.
• Treatment side effects (e.g. toxicity due to chemotherapy) for both arms will be recorded at 3, 6, 9, 12, and 15 months according to the EORTC Common Toxicity Criteria (CTC AE version 4).
- TimepointsThe neuropsychological test battery, including the questionnaires, will be administered at baseline (before GKRS or WBRT) and 3, 6, 9, 12, and 15 months after treatment.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESPhD Karin Gehring
- CONTACT for SCIENTIFIC QUERIESMD P.E.J. (Patrick) Hanssens
- Sponsor/Initiator St. Elisabeth Hospital, Tilburg, Tilburg University
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryEffective treatment for patients with BM without negative cognitive side effects is increasingly becoming more important, since more patients survive and live longer after treatment. This study aims to examine cognitive outcome and therefore quality of life in patients with BM after GKRS or WBRT.
The proposed study is a prospective randomized trial, designed to evaluate cognitive functioning over time after treatment with either GKRS or WBRT in adult patients with multiple (11-20) brain metastases in the Netherlands.
Neuropsychological assessment will be performed at baseline. Follow-up at 3, 6, 9, 12, and 15 months (cognitive testing) and 3-monthly MRI scan. Ultimately, the purpose of this line of research is to inform individual patients with BM more precisely about the (long-term) cognitive effects and the consequences they can expect from treatment with either GKRS or WBRT. This will enable patients and doctors to make a better-informed treatment decision grounded on scientific evidence.
- Main changes (audit trail)28-okt-2016:
Inclusion criteria NEW
• 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
• Lesion >3mm from brainstem or optic apparatus
• Patient age >/=18 years
• Karnofsky Performance Status >/=70
• WHO performance status ≤2
• Anticipated survival (independent of the BM) greater than 3 months
• Patient informed consent obtained (verifying that patients are aware of the investigational nature of this study).

- Exclusion criteria NEW
• No prior histologic confirmation of malignancy
• Primary brain tumor, a second (active) primary tumor
• Small cell lung cancer
• Leukemia
• Meningeal disease
• Lymphoma
• Progressive, symptomatic systemic disease without further treatment options
• Prior brain radiation
• Prior 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
• Contra indications to MRI or gadolinium contrast
• Underlying medical condition precluding adequate follow-up
• Lack of informed consent
• 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, paralysis grade 0-3 according to MRC scale (Medical Research Council)
- RECORD14-sep-2015 - 28-okt-2016


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