search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Cognitive Outcome after Gamma Knife Radiosurgery in Patients with Brain Metastases


- candidate number22861
- NTR NumberNTR5462
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-sep-2015
- Secondary IDs842003008; P1515 Project number ZonMw; Protocol ID MEC
- Public TitleCognitive Outcome after Gamma Knife Radiosurgery in Patients with Brain Metastases
- Scientific TitleCognitive Outcome after Gamma Knife Radiosurgery in Patients with Brain Metastases
- ACRONYMThe CAR study
- hypothesisThe main objective is to assess cognitive functioning over time in patients with multiple (1-10) brain metastases (BM) after Gamma Knife Radiosurgery (GKRS). Improvements and/or declines in memory, executive function, attention, processing speed, and upper extremity fine motor dexterity will be determined at baseline (before GKRS treatment) and subsequent follow-ups.
- Healt Condition(s) or Problem(s) studiedBrain metastases
- Inclusion criteriaInclusion criteria
Histologically proven malignant cancer
Imaging and clinical presentation consistent with BM; contrast enhanced volumetric MRI used for treatment planning showing 1-10 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
Melanoma, Lymphoma
Small cell lung cancer
Leukemia
Meningeal disease
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 and paralysis grade 0-3 according to MRC scale (Medical Research Council)
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytype[default]
- planned startdate 1-okt-2015
- planned closingdate30-jun-2019
- Target number of participants100
- InterventionsPatients will complete a standardized battery of neuropsychological test both at baseline and 3, 6, 9, 12, 15, and 21 months post GKRS.
- Primary outcomeCognitive functioning will be examined with a battery of neuropsychological tests: The revised Hopkins Verbal Learning Test (HVLT-R), WAIS Digit Span and Digit Symbol, TMT A and B, COWA, and Grooved Pegboard.
- Secondary outcome1) Fatigue (MFI)
2) Health related QOL (FACT-BR)
3) Depression and anxiety (HADS)
4) Overall Survival
5) Local and distant tumor control
- TimepointsThe neuropsychological test battery, including questionnaires, will be administered at baseline (before GKRS) and 3, 6, 9, 12, 15 and 21 months after treatment.
- Trial web siteN.v.t.
- 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 brain metastases (BM) without negative cognitive side effects is increasingly becoming more important, since more patients survive and live longer after treatment. The proposed study is a single-arm, prospective study designed to evaluate changes over time in cognitive function in adult patients with BM scheduled for treatment with GKRS in the Netherlands. Neuropsychological assessment will be performed at baseline (before GKRS). Follow-up at 3, 6, 9, 12, 15, and 21 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 GKRS. 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 1-10 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
Lymphoma
Small cell lung cancer
Leukemia
Meningeal disease
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 and paralysis grade 0-3 according to MRC scale (Medical Research Council
- RECORD10-sep-2015 - 28-okt-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl