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A prospective randomized study to compare neurocognitive outcome after Stereotactic Radiosurgery or Whole Brain Radiation Therapy for the treatment of multiple brain metastases

A prospective randomized study to compare neurocognitive outcome after Stereotactic Radiosurgery or Whole Brain Radiation Therapy for the treatment of multiple brain metastases - Cognitive outcome after WBRT or SRS in patients with brain metastases

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55790
Enrollment
80
Registered
2015-08-12
Start date
2016-10-13
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cognitieve stoornissen Brain metastases brain tumor

Interventions

Patients in the WBRT group will receive 4 Gy x 5 fractions in one week, which is a commonly utilized treatment schedule according to Dutch guidelines. SRS will be performed with a Leksell Gamma Knif

Sponsors

Sint Elisabeth Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Contrast enhanced volumetric MRI-scan showing 11-20 newly diagnosed BM with a total tumor volume 3 mm from optic apparatus* • Patient age >= 18 years* • Karnofsky Performance Status >= 70, WHO performance status

Exclusion criteria

Exclusion criteria: • No prior histologic confirmation of malignancy • Primary brain tumor, lymphoma, small cell lung cancer, leukemia, or meningeal disease • Progressive, symptomatic systemic disease without further treatment options • Prior brain radiation or surgical resection of BM • 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 • Patients unable to complete test battery and/or study questionnaires due to any of the following reasons: lack of basic proficiency in Dutch, IQ below 85, severe aphasia, or paralysis

Design outcomes

Primary

MeasureTime frame
• Cognitive functioning as assessed with a battery of neuropsychological tests: The revised Hopkins Verbal Learning Test (HVLT-R), WAIS Digit Span and Digit Symbol, TMT A and B, COWA, and Grooved Pegboard

Secondary

MeasureTime frame
• Fatigue (MFI) • Health related QOL (FACT-BR) • Depression and anxiety (HADS) • Overall Survival • Local and distant tumor control

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)