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

NCT02953717 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2023-09-13

No results posted yet for this study

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. 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.

Conditions

  • Neoplasm Metastasis

Interventions

RADIATION

Gamma Knife radiosurgery

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.

RADIATION

Whole Brain Radiation Therapy

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.

Sponsors & Collaborators

  • Tilburg University

    collaborator OTHER

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Elisabeth-TweeSteden Ziekenhuis

    lead OTHER

Principal Investigators

  • Patrick EJ Hanssens, MD · Gamma Knife Center Tilburg, Elisabeth-TweeSteden Hospital, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2023-07-31
Completion
2023-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02953717 on ClinicalTrials.gov