Clinical trial NCT02953756: Cognitive Outcome After Gamma Knife Radiosurgery in Patients With Brain Metastases (CAR-Study A)
Official title: Cognitive Outcome After Gamma Knife Radiosurgery in Patients With 1-10 Brain Metastases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasm Metastases
Keywords: Brain metastases
Cognition
Radiosurgery
Stereotactic radiosurgery
Gamma Knife Radiosurgery
Quality of Life
Fatigue
Anxiety
Depression
Lead sponsor: Elisabeth-TweeSteden Ziekenhuis
Sponsor class: OTHER
Collaborators: name: Tilburg University
name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2016-11-03
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* No prior histologic confirmation of malignancy
* Primary brain tumor
* A second active primary tumor
* Small cell lung cancer
* Lymphoma
* Leukemia
* 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)

Primary outcomes:
measure: Change in verbal memory
timeFrame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
measure: Change in cognitive flexibility
timeFrame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
measure: Change in word fluency
timeFrame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
measure: Change in working memory
timeFrame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
measure: Change in processing speed
timeFrame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
measure: Change in motor dexterity
timeFrame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Secondary outcomes:
measure: Health Related Quality Of Life (HRQOL)
timeFrame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
measure: Fatigue
timeFrame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
measure: Depression and anxiety
timeFrame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS.
measure: Median Overall Survival
timeFrame: 12 months after GKRS
measure: Local tumor control
timeFrame: 12 months after GKRS
measure: Distant tumor control
timeFrame: 12 months after GKRS
Other outcomes:
Locations:
city: Tilburg
country: Netherlands
facility: Gamma Knife Center Tilburg, Elisabeth-TweeSteden Hospital
state: Noord-Brabant
Study officials:
affiliation: Gamma Knife Center Tilburg, Elisabeth-TweeSteden Hospital, The Netherlands
name: Patrick EJ Hanssens, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.