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

This study is currently recruiting participants.
Verified October 2016 by Elisabeth-TweeSteden Ziekenhuis
Sponsor:
ClinicalTrials.gov Identifier:
NCT02953756
First Posted: November 3, 2016
Last Update Posted: November 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of Tilburg
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Elisabeth-TweeSteden Ziekenhuis
  Purpose

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).


Condition Intervention
Neoplasm Metastases Radiation: Gamma Knife radiosurgery

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cognitive Outcome After Gamma Knife Radiosurgery in Patients With 1-10 Brain Metastases

Further study details as provided by Elisabeth-TweeSteden Ziekenhuis:

Primary Outcome Measures:
  • 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)

  • 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)

  • 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)

  • 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

  • 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

  • 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 Outcome Measures:
  • 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.

  • Fatigue [ Time Frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS ]
    Fatigue is measured with the Multidimensional Fatigue Inventory (MFI).

  • 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).

  • 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.

  • 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.

  • 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.


Estimated Enrollment: 100
Study Start Date: October 2015
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02953756


Contacts
Contact: Wietske CM Schimmel, MSc. +31 135391333 w.schimmel@etz.nl
Contact: Eline Verhaak, MSc. +31 135391333 e.verhaak@etz.nl

Locations
Netherlands
Gamma Knife Center Tilburg, Elisabeth-TweeSteden Hospital Recruiting
Tilburg, Noord-Brabant, Netherlands, 5022 GC
Contact: Patrick EJ Hanssens, MD    +31 135392543    p.hanssens@etz.nl   
Sponsors and Collaborators
Elisabeth-TweeSteden Ziekenhuis
University of Tilburg
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Patrick EJ Hanssens, MD Gamma Knife Center Tilburg, Elisabeth-TweeSteden Hospital, The Netherlands
  More Information

Responsible Party: Elisabeth-TweeSteden Ziekenhuis
ClinicalTrials.gov Identifier: NCT02953756     History of Changes
Other Study ID Numbers: 842003008
First Submitted: October 27, 2016
First Posted: November 3, 2016
Last Update Posted: November 3, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Elisabeth-TweeSteden Ziekenhuis:
Brain metastases
Cognition
Radiosurgery
Stereotactic radiosurgery
Gamma Knife Radiosurgery
Quality of Life
Fatigue
Anxiety
Depression

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Neoplastic Processes
Neoplasms
Pathologic Processes