Brain malignancy brain tumor
Conditions
Interventions
An awake craniotomy
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age >18 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, sensor cortex, subcortical pyramidal tract or speech areas as indicated on MRI (Sawaya Grading II and II) 4. The tumor is suitable for resection (according 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 a 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. To investigate if the percentage of neurologic morbidity 6 weeks after surgery in patients with GBM in eloquent areas, operated with an awake craniotomy (AC) is significantly lower as compared to patients operated under general anesthesia (GA). 2. To investigate if the percentage of patients with a total resection with GBM in eloquent areas, operated with an awake craniotomy (AC) is significantly higher as compared to patients operated under general anesthesia (GA). The amount of total resections is measurable and has a direct relationship with the prognosis of the patients with GM. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To assess quality of life in patients with GM in eloquent areas operated with an awake craniotomy (AC) as compared to patients operated under general anesthesia (GA) at 6 weeks, 3 months and 1 year after operation. 2. To assess if median survival, progression free survival and overall survival after 1 year in patients with GM in eloquent areas operated with an awake craniotomy (AC) procedure is significantly higher as compared to patients operated under general anesthesia. | — |
Countries
Netherlands
Outcome results
None listed