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Cognitive Outcome after Gamma Knife Radiosurgery in Patients with Brain Metastases

Cognitive Outcome after Gamma Knife Radiosurgery in Patients with Brain Metastases

Status
Recruiting
Phases
Unknown
Study type
Unknown
Source
NL-OMON
Registry ID
NL-OMON28059
Enrollment
100
Registered
2015-09-10
Start date
2015-10-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain metastases

Interventions

Patients will complete a standardized battery of neuropsychological test both at baseline and 3, 6, 9, 12, 15, and 21 months post GKRS.

Sponsors

St Elisabeth Hospital, Tilburg and Tilburg University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 28-okt-2016: • 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

Exclusion criteria: 28-okt-2016: • 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

Design outcomes

Primary

MeasureTime frame
Cognitive 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

MeasureTime frame
1) Fatigue (MFI) 2) Health related QOL (FACT-BR) 3) Depression and anxiety (HADS) 4) Overall Survival 5) Local and distant tumor control

Contacts

Public ContactKarin Gehring

Tilburg University - department of Cognitive Neuropsychology - Simon building - room S 219

k.gehring@uvt.nl+31 13 466 2408

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)