NCT02953756

Brief 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). 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 3, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

August 14, 2020

Status Verified

February 1, 2020

Enrollment Period

4 years

First QC Date

October 27, 2016

Last Update Submit

August 13, 2020

Conditions

Neoplasm Metastases

Keywords

Brain metastasesCognitionRadiosurgeryStereotactic radiosurgeryGamma Knife RadiosurgeryQuality of LifeFatigueAnxietyDepression

Outcome Measures

Primary Outcomes (6)

  • Change in verbal memory

    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

    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

    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

    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

    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

    Motor dexterity is measured with the Grooved Pegboard (GP)

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

Secondary Outcomes (6)

  • Health Related Quality Of Life (HRQOL)

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

  • Fatigue

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

  • Depression and anxiety

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

  • Median Overall Survival

    12 months after GKRS

  • Local tumor control

    12 months after GKRS

  • +1 more secondary outcomes

Study Arms (1)

Stereotactic radiosurgery (SRS)

Gamma Knife radiosurgery (GKRS)

Radiation: Gamma Knife radiosurgery

Interventions

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

Stereotactic radiosurgery (SRS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Histologically proven malignant cancer
  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gamma Knife Center Tilburg, Elisabeth-TweeSteden Hospital

Tilburg, North Brabant, 5022 GC, Netherlands

Location

Related Publications (4)

  • 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.

    PMID: 37249646DERIVED

  • 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.

    PMID: 33025282DERIVED

  • 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.

    PMID: 31552588DERIVED

  • 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.

    PMID: 31342318DERIVED

MeSH Terms

Conditions

Neoplasm MetastasisBrain NeoplasmsFatigueAnxiety DisordersDepression

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSigns and SymptomsMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Patrick EJ Hanssens, MD

    Gamma Knife Center Tilburg, Elisabeth-TweeSteden Hospital, The Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2016

First Posted

November 3, 2016

Study Start

October 1, 2015

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

August 14, 2020

Record last verified: 2020-02

Locations

NL(1)