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Neoplasm MetastasisNCT02953717

Cognitive Outcome After SRS or WBRT in Patients With Multiple Brain Metastases (CAR-Study B)

A study testing Gamma Knife radiosurgery and Whole Brain Radiation Therapy in people with Neoplasm Metastasis, 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
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Trial summary

Whole Brain Radiation Therapy (WBRT) has long been the mainstay of treatment for patients with multiple brain metastases (BM). Meanwhile, Gamma Knife radiosurgery (GKRS) has been increasingly employed in the management of multiple BM to spare healthy tissue. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasm Metastasis
What is being tested?
Gamma Knife radiosurgery and Whole Brain Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
1 siteNetherlands
Study dates
Feb 2016to 11 Jan 2023
Phase
Interventional
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

Who may be able to join

  • Histologically proven malignant cancer
  • 11-20 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 (SCLC)
  • Lymphoma
  • Leukemia
Show all 19Show fewer
  • Meningeal disease
  • Progressive, symptomatic systemic disease without further treatment options
  • Prior brain radiation
  • Prior surgical resection of BM
  • Cardiovascular accident (CVA) < 2 years ago
  • Additional history of a significant neurological or psychiatric disorder
  • Contra indications to MRI or gadolinium contrast
  • Underlying medical condition precluding adequate follow-up
  • Participation in a concurrent study in which neuropsychological testing and/or health-related QOL assessments are involved
  • 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: A Prospective Randomized Study to Compare Cognitive Outcome After Stereotactic Radiosurgery or Whole Brain Radiation Therapy in Patients With 11-20 Brain Metastases

Whole Brain Radiation Therapy (WBRT) has long been the mainstay of treatment for patients with multiple brain metastases (BM). Meanwhile, Gamma Knife radiosurgery (GKRS) has been increasingly employed in the management of multiple BM to spare healthy tissue. Hence, GKRS is expected to cause fewer cognitive side effects than WBRT. Treatment of multiple BM without cognitive side effects is becoming more important, as more patients live longer due to better systemic treatment options. There are no published randomized trials yet directly comparing GKRS to WBRT in patients with multiple BM, including objective neuropsychological testing.

CAR-Study B is a prospective randomized trial comparing cognitive outcome after GKRS or WBRT in eligible patients with 11-20 BM.

Read the detailed description

CAR-Study B is a prospective randomized trial comparing cognitive outcome after GKRS or WBRT in eligible patients with 11-20 BM on a triple dose gadolinium-enhanced MRI-scan. Neuropsychological assessment will be performed at baseline and at 3, 6, 9, 12 and 15 months after treatment. Follow-up assessments will be combined with 3-monthly MRI-scans.

Patients will be randomized to either GKRS or WBRT. Groups will be balanced at baseline (prior to radiotherapy), taking into account several (stratification) factors that may influence cognitive functioning over time, such as: total tumor volume in the brain, systemic treatment, KPS, age, histology, and baseline HVLT-R total recall score.

Being tested
Gamma Knife radiosurgery, Whole Brain Radiation Therapy
Keywords
Brain metastases, Cognition, Radiosurgery, Gamma Knife Radiosurgery, Stereotactic radiosurgery, Whole Brain Radiation Therapy, 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

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

  • Whole Brain Radiation TherapyRadiation

    Patients in the WBRT group will receive 4 Gy x 5 fractions (total of 20 Gy) in one week, which is a commonly utilized treatment schedule according to Dutch guidelines.

Study groups in NCT02953717
Study groupRoleWhat they receive
Stereotactic radiosurgery (SRS)Active comparatorGamma Knife radiosurgery
Receives: Radiation: Gamma Knife radiosurgery
Whole Brain Radiation Therapy (WBRT)Active comparatorWhole Brain Radiation Therapy
Receives: Radiation: Whole Brain Radiation Therapy

What is being measured

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

  1. Cognitive decline at 3 months

    Cognitive decline is defined as a significant decline (5 point decrease from baseline based on the Reliable Change Index (RCI) with correction for practice effects) in HVLT-R Total Recall score (verbal learning and memory test) after treatment with either GKRS or WBRT in patients with 11-20 brain metastases at time of treatment initiation.

    Measured: 3 months

Secondary outcomes (12)

  1. Verbal memory

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

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

  2. Cognitive flexibility

    Cognitive flexibility is measured with the Controlled Oral Word Association (COWA)

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

  3. Word Fluency

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

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

  4. Working memory

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

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

  5. Processing speed

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

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

  6. Motor dexterity

    Motor dexterity is measured with the Grooved Pegboard (GP)

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

  7. 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 and 15 months post GKRS/WBRT

  8. Fatigue

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

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

  9. Depression and anxiety

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

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

  10. Median Overall Survival

    Overall survival is defined as the time in months from the start of treatment to the date of death or last contact if alive. Kaplan-Meier methods are used to estimate overall survival.

    Measured: 12 months after GKRS/WBRT

  11. Local tumor control

    Local brain tumor control of the initial 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/WBRT

  12. Distant tumor control

    Distant brain tumor control is defined as the absence of any new brain metastases, distinct from the initial 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/WBRT

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 startFeb 2016
  3. Primary completion11 Jan 2023
  4. Study completion11 Jan 2023

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02953717
Sponsor's protocol ID
842003006
Other IDs
NTR5463
Status last verified
Jun 2026
First submitted
27 Oct 2016
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Schimmel WCM, Verhaak E, Hanssens PEJ, Gehring K, Sitskoorn MM. A randomised trial to compare cognitive outcome after gamma knife radiosurgery versus whole brain radiation therapy in patients with multiple brain metastases: research protocol CAR-study B. BMC Cancer. 2018 Feb 21;18(1):218. doi: 10.1186/s12885-018-4106-2.

    PubMed 29466961

Questions about this trial

What is this clinical trial studying?

A study testing Gamma Knife radiosurgery and Whole Brain Radiation Therapy in people with Neoplasm Metastasis, 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 19 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 10 Jun 2026. 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?

Cognitive decline at 3 months (time frame: 3 months). 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 NCT02953717, which also lists 1 linked publication.

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 10 Jun 2026.

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