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

August 13, 2020 updated by: Elisabeth-TweeSteden Ziekenhuis

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

92

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Noord-Brabant
      • Tilburg, Noord-Brabant, Netherlands, 5022 GC
        • Gamma Knife Center Tilburg, Elisabeth-TweeSteden Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Stereotactic radiosurgery (SRS)
Gamma Knife radiosurgery (GKRS)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in verbal memory
Time Frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
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
Change in cognitive flexibility
Time Frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Cognitive flexibility is measured with the Trail Making Test B (TMT B)
Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Change in word fluency
Time Frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Word Fluency is measured with the Controlled Oral Word Association (COWA)
Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Change in working memory
Time Frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Working memory is measured with the Wechsler Adult Intelligence Scale - Digit Span
Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Change in processing speed
Time Frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Processing speed is measured with the Wechsler Adult Intelligence Scale - Digit Symbol
Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Change in motor dexterity
Time Frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Motor dexterity is measured with the Grooved Pegboard (GP)
Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Related Quality Of Life (HRQOL)
Time Frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
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
Fatigue
Time Frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Fatigue is measured with the Multidimensional Fatigue Inventory (MFI).
Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS
Depression and anxiety
Time Frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS.
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.
Median Overall Survival
Time Frame: 12 months after GKRS
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
Local tumor control
Time Frame: 12 months after GKRS
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
Distant tumor control
Time Frame: 12 months after GKRS
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elisabeth-TweeSteden Ziekenhuis

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development
Tilburg University

Investigators

  • Principal Investigator: Patrick EJ Hanssens, MD, Gamma Knife Center Tilburg, Elisabeth-TweeSteden Hospital, The Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

October 27, 2016

First Submitted That Met QC Criteria

November 1, 2016

First Posted (Estimate)

November 3, 2016

Study Record Updates

Last Update Posted (Actual)

August 14, 2020

Last Update Submitted That Met QC Criteria

August 13, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 842003008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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