Glioblastoma
Conditions
Interventions
Sponsors
Dutch Cancer Society
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age =18 years and = 90 years 2. Tumor diagnosed as Glioblastoma Multiforme on MRI with distinct ring-like pattern of contrast enhancement with thick irregular walls and a core area reduced signal suggestive of tumour necrosis as assessed by the surgeon 3. Tumors situated in or near eloquent areas; motor cortex, sensory cortex, subcortical pyramidal tract or speech areas as indicated on MRI (Sawaya Grading II and II) [47] 4. The tumor is suitable for resection (according to neurosurgeon) 5. Karnofsky performance scale 80 or more 6. No severe aphasia or dysphasia; able to communicate during an awake procedure 7. 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 (eg, pacemaker) 5. Inability to give consent because of or language barrier 6. Psychiatric history 7. Previous brain tumour 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. 10. Severe aphasia or dysphasia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks post-surgery, where deterioration is defined as at least one point increase in total NIHSS score compared to baseline 2. Proportion of patients without residual contrast-enhancing tumour on postoperative MRI, where residual tumour is defined as contrast-enhancement with a volume more than 0.175 cm3. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health related quality of life (HRQoL) at 6 weeks, 3 and 6 months after operation, where HRQol is measured with the QLQ-C30, QLQ-BN20 and EQ-5D questionnaires. 2. Progression-free survival (PFS) at 12 months defined as time from diagnosis to disease progression (occurrence of a new tumour lesion with a volume greater than 0.175 cm3, or an increase in residual tumour volume of more than 25%) or death, whichever comes first. 3. Overall survival (OS) at 12 months defined as time from diagnosis to death from any cause. 4. Frequency and severity of Serious Adverse Effects in each group: Infections, intracerebral bleeding, epilepsy, aphasia, paresis/paralysis in arms or/and legs. | — |
Contacts
Public ContactJasper Gerritsen
Erasmus MC
Outcome results
None listed