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

Neoplasm Metastases Clinical Trial

Official title:

Cognitive Outcome After Gamma Knife Radiosurgery in Patients With 1-10 Brain Metastases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02953756
• Other study ID #: 842003008
• Status: Completed
• Start date: October 2015
• Est. completion date: October 2019

Study information

• Verified date: February 2020
• Source: Elisabeth-TweeSteden Ziekenhuis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Neoplasm Metastases
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Radiation:
• Gamma Knife radiosurgery
Gamma Knife radiosurgery will be performed with a Leksell Gamma Knife® Icon, Elekta Instruments, AB. Depending upon the tumor volume, a dose of 18-25 Gy will be prescribed with 99-100% coverage of the target

Locations

Country	Name	City	State
Netherlands	Gamma Knife Center Tilburg, Elisabeth-TweeSteden Hospital	Tilburg	Noord-Brabant

Sponsors (3)

Lead Sponsor	Collaborator
Elisabeth-TweeSteden Ziekenhuis	University of Tilburg, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in verbal memory	Verbal memory is measured with the Hopkins Verbal Learning Test-Revised (HVLT-R)	Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Primary	Change in cognitive flexibility	Cognitive flexibility is measured with the Trail Making Test B (TMT B)	Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Primary	Change in word fluency	Word Fluency is measured with the Controlled Oral Word Association (COWA)	Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Primary	Change in working memory	Working memory is measured with the Wechsler Adult Intelligence Scale - Digit Span	Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Primary	Change in processing speed	Processing speed is measured with the Wechsler Adult Intelligence Scale - Digit Symbol	Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Primary	Change in motor dexterity	Motor dexterity is measured with the Grooved Pegboard (GP)	Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Secondary	Health Related Quality Of Life (HRQOL)	The Functional Assessment of Cancer Therapy-Brain (FACT-Br) is used to measure HRQOL.	Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Secondary	Fatigue	Fatigue is measured with the Multidimensional Fatigue Inventory (MFI).	Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Secondary	Depression and anxiety	Depression and anxiety are measured with the Hospital Anxiety and Depression Scale (HADS).	Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS.
Secondary	Median Overall Survival	Overall survival is defined as the time in months from the start of GKRS to the date of death or last contact if alive. Kaplan-Meier methods are used to estimate overall survival.	12 months after GKRS
Secondary	Local tumor control	Local brain tumor control of the initial GKRS-treated lesions is defined as a complete, partial, or stable response, or less than a 25% increase in diameter on contrast-enhanced MRI follow-up and not requiring resection. Any initial treated lesions increased by more than 25% in diameter on contrast-enhanced MRI or required resection will be considered a local failure.	12 months after GKRS
Secondary	Distant tumor control	Distant brain tumor control is defined as the absence of any new brain metastases, distinct from the initial GKRS-treated lesion(s), on follow-up MRI. The appearance of one or more new lesions in the brain by contrast-enhanced follow-up MRI is considered distant failure.	12 months after GKRS