The SAFE-Trial: Awake Craniotomy Versus Surgery Under General Anesthesia for Glioblastoma Patients. (SAFE)
Glioblastoma, Glioblastoma Multiforme, Glioblastoma Multiforme of Brain
About this trial
This is an interventional treatment trial for Glioblastoma focused on measuring Glioblastoma, Neurological morbidity, Postoperative complications, Extent of resection, Gross-total resection, Health-related quality of life, Progression-free survival, Overall survival
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 years and ≤ 90 years
- 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
- 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)
- The tumor is suitable for resection (according to neurosurgeon)
- Karnofsky performance scale 80 or more
- Written Informed consent
Exclusion Criteria:
- Tumors of the cerebellum, brain stem or midline
- Multifocal contrast enhancing lesions
- Substantial non-contrast enhancing tumor areas suggesting low grade gliomas with malignant transformation
- Medical reasons precluding MRI (eg, pacemaker)
- Inability to give consent because of or language barrier
- Psychiatric history
- Previous brain tumour surgery
- Previous low-grade glioma.
- 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.
- Severe aphasia or dysphasia
Sites / Locations
- University Hospital GhentRecruiting
- Elisabeth-Tweesteden ZiekenhuisRecruiting
- Erasmus MCRecruiting
- Medical Center HaaglandenRecruiting
- University Medical Center GroningenRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Awake craniotomy
Craniotomy under general anesthesia
Cortical stimulation is performed with a bipolar electrical stimulator. The Boston naming test and repetition of words is done in cooperation with a neuropsychologist/linguist, who will inform the neurosurgeon of any kind of speech arrest or dysarthria. When localizing the motor and sensory cortex, the patient is asked to report any unintended movement or sensation in extremities or face. Functional cortical areas are marked with a number. When the tumour margins or white matter is encountered or when on regular neuronavigation the eloquent white matter tracts are thought to be in close proximity, subcortical stimulation (biphasic currents of 8-16 mA, pulse frequency 60 Hz, single pulse phase duration of 100 microsec., 2-second train) is performed to localize functional tracts.
Trephination and tumour resection are performed without any additional neuro-psychological monitoring or brain mapping, guided by STEALTH-neuronavigation.