AzTrials
AzTrials

Neoplasm MetastasesNCT02953756

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

An observational study of Neoplasm Metastases, run by Elisabeth-TweeSteden Ziekenhuis at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasm Metastases
What is being tested?
Gamma Knife radiosurgery
Type of treatment
Surgery or procedure
How many people
92 participants
Where
1 siteNetherlands
Study dates
Oct 2015to Oct 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • No prior histologic confirmation of malignancy
  • Primary brain tumor
  • A second active primary tumor
  • Small cell lung cancer
  • Lymphoma
  • Leukemia
Show all 18Show fewer
  • 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 locations and contacts

1 site in 1 country.

Netherlands1 site

  • Gamma Knife Center Tilburg, Elisabeth-TweeSteden Hospital

    Tilburg, North Brabant, 5022 GC

Other trials in Netherlands

About this study

Official title: 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).

Read the 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.

Being tested
Gamma Knife radiosurgery
Keywords
Brain metastases, Cognition, Radiosurgery, Stereotactic radiosurgery, Gamma Knife Radiosurgery, Quality of Life, Fatigue, Anxiety, Depression
Medical subject headings
Neoplasm Metastasis, Brain Neoplasms, Fatigue, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gamma Knife radiosurgeryRadiation

    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

Study groups in NCT02953756
Study groupRoleWhat they receive
Stereotactic radiosurgery (SRS)Gamma Knife radiosurgery (GKRS)
Receives: Radiation: Gamma Knife radiosurgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in verbal memory

    Verbal memory is measured with the Hopkins Verbal Learning Test-Revised (HVLT-R)

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

  2. Change in cognitive flexibility

    Cognitive flexibility is measured with the Trail Making Test B (TMT B)

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

  3. Change in word fluency

    Word Fluency is measured with the Controlled Oral Word Association (COWA)

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

  4. Change in working memory

    Working memory is measured with the Wechsler Adult Intelligence Scale - Digit Span

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

  5. Change in processing speed

    Processing speed is measured with the Wechsler Adult Intelligence Scale - Digit Symbol

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

  6. Change in motor dexterity

    Motor dexterity is measured with the Grooved Pegboard (GP)

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

Secondary outcomes (6)

  1. Health Related Quality Of Life (HRQOL)

    The Functional Assessment of Cancer Therapy-Brain (FACT-Br) is used to measure HRQOL.

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

  2. Fatigue

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

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

  3. Depression and anxiety

    Depression and anxiety are measured with the Hospital Anxiety and Depression Scale (HADS).

    Measured: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS.

  4. 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.

    Measured: 12 months after GKRS

  5. 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.

    Measured: 12 months after GKRS

  6. 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.

    Measured: 12 months after GKRS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2016 (estimated)
  2. Study startOct 2015
  3. Primary completionOct 2019
  4. Study completionOct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02953756
Sponsor's protocol ID
842003008
Status last verified
Feb 2020
First submitted
27 Oct 2016
Last updated
14 Aug 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Verhaak E, Schimmel WCM, Sitskoorn MM, Hanssens PEJ, Butterbrod E, Gehring K. The long-term course and relationship with survival of multidimensional fatigue in patients with brain metastases after Gamma Knife radiosurgery. J Cancer Res Clin Oncol. 2023 Sep;149(12):9891-9901. doi: 10.1007/s00432-023-04857-1. Epub 2023 May 30.

    PubMed 37249646

  • Verhaak E, Schimmel WCM, Gehring K, Emons WHM, Hanssens PEJ, Sitskoorn MM. Health-related quality of life after Gamma Knife radiosurgery in patients with 1-10 brain metastases. J Cancer Res Clin Oncol. 2021 Apr;147(4):1157-1167. doi: 10.1007/s00432-020-03400-w. Epub 2020 Oct 6.

    PubMed 33025282

  • Schimmel WCM, Gehring K, Hanssens PEJ, Sitskoorn MM. Cognitive functioning and predictors thereof in patients with 1-10 brain metastases selected for stereotactic radiosurgery. J Neurooncol. 2019 Nov;145(2):265-276. doi: 10.1007/s11060-019-03292-y. Epub 2019 Sep 24.

    PubMed 31552588

  • Butterbrod E, Bruijn J, Braaksma MM, Rutten GM, Tijssen CC, Hanse MCJ, Sitskoorn MM, Gehring K. Predicting disease progression in high-grade glioma with neuropsychological parameters: the value of personalized longitudinal assessment. J Neurooncol. 2019 Sep;144(3):511-518. doi: 10.1007/s11060-019-03249-1. Epub 2019 Jul 24.

    PubMed 31342318

Questions about this trial

What is this clinical trial studying?

An observational study of Neoplasm Metastases, run by Elisabeth-TweeSteden Ziekenhuis at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in verbal memory (time frame: Baseline and 3, 6, 9, 12, 15, and 21 months post GKRS). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02953756, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in