Clinical trial · Observational
Cognitive Outcome After Gamma Knife Radiosurgery in Patients With Brain Metastases (CAR-Study A)
Cognitive Outcome After Gamma Knife Radiosurgery in Patients With 1-10 Brain Metastases
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm Metastases | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gamma Knife radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Stereotactic radiosurgery (SRS)
- description
- Gamma Knife radiosurgery (GKRS)
- interventionNames
- Radiation: Gamma Knife radiosurgery
Primary outcomes (6)
- measure
- Change in verbal memory
- timeFrame
- Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
- description
- Verbal memory is measured with the Hopkins Verbal Learning Test-Revised (HVLT-R)
- measure
- Change in cognitive flexibility
- timeFrame
- Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
- description
- Cognitive flexibility is measured with the Trail Making Test B (TMT B)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (4)
- DERIVEDVerhaak E, Schimmel WCM, Sitskoorn MM, Hanssens PEJ, Butterbrod E, Gehring K. The long-term course and relationship with survival of multidimensional fatigue in patients with brain metastases after Gamma Knife radiosurgery. J Cancer Res Clin Oncol. 2023 Sep;149(12):9891-9901. doi: 10.1007/s00432-023-04857-1. Epub 2023 May 30. PMID 37249646
- DERIVEDVerhaak 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. PMID 33025282
- DERIVEDSchimmel 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. PMID 31552588
- DERIVEDButterbrod 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. PMID 31342318