Cognitive Outcome After Gamma Knife Radiosurgery in Patients With Brain Metastases (CAR-Study A)

Elisabeth-TweeSteden Ziekenhuis

Status: Completed

Conditions: Neoplasm Metastases

Treatments: Radiation: Gamma Knife radiosurgery

Study type: Observational

Funder types: Other

Identifiers

NCT02953756

842003008

Details and patient eligibility

About

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).

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

92 participants in 1 patient group

Stereotactic radiosurgery (SRS)

Description:

Gamma Knife radiosurgery (GKRS)

Treatment:

Radiation: Gamma Knife radiosurgery