Primary Objective Our primary aim is to evaluate the course of cognitive functioning (stability, impairment or decline, or improvement as compared to Dutch controls) after usual care SRS in patients with 1-10 BM at time of treatment initiation.…
ID
Source
Brief title
Condition
- Other condition
- Metastases
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Health condition
cognitieve stoornissen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Cognitive functioning as assessed 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 outcome
* Fatigue (MFI)
* Health related QOL (FACT-BR)
* Depression and anxiety (HADS)
* Overall Survival
* Local and distant tumor control
Background summary
Stereotactic radiosurgery (SRS) is at the least an equally effective treatment
for brain metastases (BM) with regard to survival and tumor control as is whole
brain radiation therapy (WBRT). SRS is expected to cause fewer cognitive side
effects. However, cognitive effects of SRS have not been examined with formal
neuropsychological testing, except for the studies by Chang et al (2007; pilot
n=15, 2009; n=30 in the SRS arm), which are considered landmark studies despite
their small sample sizes. Our aim is to assess cognitive functioning over time
in patients with BM after treatment with SRS in a sufficiently large sample.
Study objective
Primary Objective
Our primary aim is to evaluate the course of cognitive functioning (stability,
impairment or decline, or improvement as compared to Dutch controls) after
usual care SRS in patients with 1-10 BM at time of treatment initiation.
Improvements and/or declines in memory, executive function, attention,
processing speed, and upper extremity fine motor dexterity will be determined
at baseline (before SRS treatment) and 3, 6, 12, 9, 15 and 21 months after
treatment.
Secondary Objectives
* To determine overall survival
* To determine local and distant tumor control in the brain at 3, 6, 9, 12,15
and 21 months post treatment
* To assess psychological functioning (fatigue, depression and anxiety) and
health related Quality of Life (QOL) both at baseline and 3, 6, 9, 12, 15, and
21 months post treatment
* To identify possible predictors of cognitive functioning (age, sex, number
and cumulative volume of BM, extracranial disease status, type and duration of
systemic and salvage therapies, local and distant control, psychological
functioning) after treatment
Study design
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 SRS. Neuropsychological assessment will be performed at baseline
(before SRS). Follow-up at 3, 6, 9, 12, 15, and 21 months (cognitive testing)
and 3-monthly MRI scan.
SRS will be performed with a Leksell Gamma Knife® Icon, Electa Instruments, AB
(Gamma Knife Radiosurgery: GKRS). Depending upon the volume of the BM, a dose
of 18-25 Gy will be prescribed with 99-100% coverage of the target.
Study burden and risks
Neuropsychological assessments (existing of six tests and three questionnaires)
will take mental effort. To reduce this effort as much as possible, a shortened
neuropsychological test battery was chosen (90 minutes). Moreover, assessments
will be combined with patients' hospital visits.
Ultimately, the purpose of this line of research is to assist both doctors and
patients in individual decision-making with regard to the cognitive effects of
treatment with either WBRT or SRS.
Hilvarenbeekse Weg 60
Tilburg 5022 GC
NL
Hilvarenbeekse Weg 60
Tilburg 5022 GC
NL
Listed location countries
Age
Inclusion criteria
* Contrast enhanced volumetric MRI showing 1-10 newly diagnosed BM with a total tumor volume * 30cc
* Lesion > 3 mm from optic apparatus*
* Patient age * 18 years*
* Karnofsky Performance Status * 70, WHO performance status * 2*
* Anticipated survival (independent of the BM) greater than 3 months
Dutch healthy control subjects will be:
* Sociodemographically similar to the patient group
* In good health, with no current or past psychiatric, neurologic, or cognitive disorder, and mediation-use that interferes with cognitive function
Exclusion criteria
* No prior histologic confirmation of malignancy
* Primary brain tumor, small cell lung cancer, lymphoma, leukemia, or meningeal disease
* Progressive, symptomatic systemic disease without further treatment options
* Prior brain radiation or 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
* 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, or paralysis
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53472.028.15 |