Brain malignancy brain tumor
Conditions
Interventions
Biopsy versus maximum safe tumor resection.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
65 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age >=70 years 2. Tumor diagnosed as glioblastoma on MRI with distinct ring-like pattern of contrast enhancement with thick irregular walls and a core area reduced signal suggestive of tumor necrosis as assessed by the surgeon. 3. Karnofsky Performance Score (KPS) >=70 4. Written Informed consent
Exclusion criteria
Exclusion criteria: 1. Tumors of the cerebellum, brain stem or midline 2. Multifocal contrast enhancing lesions 3. Substantial non-contrast enhancing tumor areas suggesting low grade gliomas with malignant transformation 4. Medical reasons precluding MRI (e.g. pacemaker) 5. Inability to give consent as assessed by neurosurgeon (e.g. language barrier) 6. Severe aphasia prohibiting neurolinguistic testing and comprehension of informed consent 7. Previous brain tumor surgery 8. Previous low-grade glioma 9. Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Overall survival (OS) at 12 months, defined as the time from diagnosis to the death of the patient from any cause. 2) The difference in mean changes scores of physical functioning, as measured with the EORTC QLQ-C30 physical functioning scale, between the two groups at 6 weeks and 3 months after surgery compared to mean score on baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Progression-free survival (PFS), defined as the time from diagnosis to disease progression (increase in residual tumor volume of more than 25%, or occurrence of a new tumor lesion with a volume greater than 0.175cm3), or death. As according to the RANO criteria. 2) The difference in mean score of physical functioning, as measured with the EORTC QLQ-C30 physical scale, between the two groups at 6 months and 12 months after surgery compared to mean score on baseline. 3) The proportion of patients with deterioration, improvement or stable physical functioning, as measured with the EORTC QLQ-C30 physical scale at 6 weeks, 3 months, 6 months and 12 months after surgery compared to baseline 4) Changes in the mean scores on the other health-related quality of life (HRQoL) scales at 6 weeks, 3 months, 6 months and 12 months after surgery compared to baseline scores. These HRQoL aspects will be measured using the EORTC QLQ-C30, EORTC QLQ-BN20 and EQ-5D questionnaires. 5) Proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration, improvement or stability at 6 weeks, 3 months, 6 months and 12 months after surgery compared to baseline, in which deterioration is defined as an increase of at least one point and improvement as a decrease of at least one point on the total NIHSS score compared to this score at baseline. 6) Differences between the groups in cognitive and neurolinguistic screening at 3 months, compared to baseline as measured by the Aphasia Bedside Check (ABC), Shortened Token Test, verbal fluency (category and letter), Montreal Cognitive Assessment (MOCA) and, optionally, CAT-NL Picture Description and Object Naming. 7) Comparison of the (S)AEs in both groups. 8) Cost-effectiveness between the two treatments. | — |
Countries
Netherlands
Outcome results
None listed