Brain metastases
Conditions
Interventions
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 (
Sponsors
St Elisabeth Hospital, Tilburg and Tilburg University
Eligibility
Inclusion criteria
Inclusion criteria: • 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).
Exclusion criteria
Exclusion criteria: • 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Differences in percentage of patients with a 5 or more point decrease in HVLT-R between treatment arms will be assessed at 6, 9, 12, and 15 months as is done for 3 months for the primary endpoint. We will assess both proportions at each time and the overall trend of change over time. • Group mean scores for all neuropsychological tests will be determined for both treatment arms at baseline, 3, 6, 9, 12, and 15 months. We will assess both proportions at each time and the overall trend of change over time. • Overall survival will be measured from the first day of treatment to date of death or last study follow-up (15 months). • Local and distant brain tumor control of the initial GKRS- or WBRT-treated lesions is defined according to the RECIST Response Criteria. • Depression, anxiety, health related QOL and fatigue. • Type and duration of systemic therapy and medication use will be recorded. The total number of cycles of systemic therapy will be calculated from either the day of treatment with GKRS or from the first day of WBRT. • Treatment side effects (e.g. toxicity due to chemotherapy) for both arms will be recorded at 3, 6, 9, 12, and 15 months according to the EORTC Common Toxicity Criteria (CTC AE version 4). | — |
Contacts
Public ContactKarin Gehring
Tilburg University - department of Cognitive Neuropsychology - Simon building - room S 219
Outcome results
None listed