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NCT Number: NCT02953756

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

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).

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Key information

Conditions

Neoplasm Metastases Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Depression Fatigue Mental Disorders Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gamma Knife Center Tilburg, Elisabeth-TweeSteden Hospital

Tilburg, North Brabant, 5022 GC, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Gamma Knife radiosurgery

Radiation

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

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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

  5. 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

  6. 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)

Secondary outcomes

  1. 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.

  2. Fatigue

    Time frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS

    Fatigue is measured with the Multidimensional Fatigue Inventory (MFI).

  3. 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).

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Elisabeth-TweeSteden Ziekenhuis

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Nov 3, 2016
Registry last updated
Aug 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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