Effective treatment for patients with brain metastases (BM) without negative cognitive side effects is increasingly becoming more important, since more patients survive and live longer after treatment. Ultimately, the purpose of this line of…
ID
Bron
Verkorte titel
Aandoening
Brain metastases
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The definition of the primary endpoint is the statistically significant difference in the percentage of patients with significant cognitive decline at three months between treatment groups. Decline is defined as a 5-point decrease from baseline based on the reliable change index (with correction for practice effects) in HVLT-R Total Recall score.
Achtergrond van het onderzoek
Effective treatment for patients with BM without negative cognitive side effects is increasingly becoming more important, since more patients survive and live longer after treatment. This study aims to examine cognitive outcome and therefore quality of life in patients with BM after GKRS or WBRT.
The proposed study is a prospective randomized trial, designed to evaluate cognitive functioning over time after treatment with either GKRS or WBRT in adult patients with multiple (11-20) brain metastases in the Netherlands.
Neuropsychological assessment will be performed at baseline. Follow-up at 3, 6, 9, 12, and 15 months (cognitive testing) and 3-monthly MRI scan. Ultimately, the purpose of this line of research is to inform individual patients with BM more precisely about the (long-term) cognitive effects and the consequences they can expect from treatment with either GKRS or WBRT. This will enable patients and doctors to make a better-informed treatment decision grounded on scientific evidence.
Doel van het onderzoek
Effective treatment for patients with brain metastases (BM) without negative cognitive side effects is increasingly becoming more important, since more patients survive and live longer after treatment. Ultimately, the purpose of this line of research is to inform individual patients with BM more precisely about the (long-term) cognitive effects and the consequences they can expect from treatment with either whole brain radiation therapy (WBRT) or Gamma Knife Radiosurgery (GKRS). This will enable patients and doctors to make a better informed treatment decision grounded on scientific evidence. This study aims to examine cognitive outcome and therefore QOL in patients with BM after WBRT or GKRS.
Onderzoeksopzet
The neuropsychological test battery, including the questionnaires, will be administered at baseline (before GKRS or WBRT) and 3, 6, 9, 12, and 15 months after treatment.
Onderzoeksproduct en/of interventie
Patients will complete a standardized battery of neuropsychological test both at baseline
and 3, 6, 9, 12, and 15 months post GKRS or WBRT. 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. GKRS will be performed with a (fully robotic) Leksell Gamma Knife® Perfexion, Elekta Instruments, AB. Depending upon the volume, a dose of 18-25 Gy will be prescribed with 99-100% coverage of the target.
Publiek
Karin Gehring
PO Box 90153
Tilburg 5000 LE
The Netherlands
+31 13 466 2408
k.gehring@uvt.nl
Wetenschappelijk
Karin Gehring
PO Box 90153
Tilburg 5000 LE
The Netherlands
+31 13 466 2408
k.gehring@uvt.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Histologically proven malignant cancer
• Imaging and clinical presentation consistent with BM; contrast enhanced volumetric MRI used for treatment planning showing 11-20 newly diagnosed BM with a maximum total tumor volume of 30 cm3
• Lesion >3mm from brainstem or optic apparatus
• Patient age >/=18 years
• Karnofsky Performance Status >/=70
• WHO performance status ≤2
• Anticipated survival (independent of the BM) greater than 3 months
• Patient informed consent obtained (verifying that patients are aware of the investigational nature of this study).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• No prior histologic confirmation of malignancy
• Primary brain tumor, a second (active) primary tumor
• Small cell lung cancer
• Leukemia
• Meningeal disease
• Lymphoma
• Progressive, symptomatic systemic disease without further treatment options
• Prior brain radiation
• Prior 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
• Contra indications to MRI or gadolinium contrast
• Underlying medical condition precluding adequate follow-up
• Lack of informed consent
• 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, paralysis grade 0-3 according to MRC scale (Medical Research Council)
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5353 |
| NTR-old | NTR5463 |
| Ander register | Project number ZonMw; Protocol ID MEC : 842003006; P1516 |