Compares two brain surgery methods for glioblastoma tumors in eloquent areas

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a suspected glioblastoma (a fast-growing brain tumour) in or near brain areas that control movement, feeling or speech. Half will have surgery while awake and half under general anaesthesia.

Age

18 to 90 years

Sex

Men and women can join.

Disease stage

Suspected glioblastoma on MRI, in or near areas for movement, feeling or speech, that the neurosurgeon can remove by surgery. Karnofsky performance scale of 80 or more.

Earlier treatment

No previous brain tumour surgery.

Main reasons for not taking part

• Tumours of the cerebellum, brain stem or midline
• Several contrast-enhancing lesions in the brain
• Previous low-grade glioma
• Another primary cancer within the past 5 years (with some exceptions)
• Severe aphasia or dysphasia (serious speech problems)

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 90 years old?YesNo

What the trial wants to find out

The trial is designed as a multicenter randomized controlled study. 246 patients with presumed Glioblastoma Multiforme in eloquent areas on diagnostic MRI will be selected by the neurosurgeons according the eligibility criteria (see under). After written informed consent is obtained, the patient will be randomized for an awake craniotomy (AC) (+/-123 patients) or craniotomy under general anesthesia (GA) (+/-123 patients), with 1:1 allocation ratio. Under GA the amount of resection of the tumour has to be performed within safe margins as judged by the surgeon during surgery. The second group will be operated with an awake craniotomy procedure where the resection boundaries for motor or language functions will be identified by direct cortical and subcortical stimulation. After surgery, the diagnosis of GBM will have to be histologically confirmed. If GBM is not histologically confirmed, patients will be considered off-study and withdrawn from the study. These patients will be followed-up according to standard practice. Thereafter, patients will receive the standard treatment with concomitant Temozolomide and radiation therapy and standard follow up. Total duration of the study is 5 years. Patient inclusion is expected to take 4 years. Follow-up is 1 year after surgery. Statistical analysis, cost benefit analysis and article writing will take 3 months.

The 2 groups in the trial

• Awake craniotomyTreatment being tested

  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.

• Craniotomy under general anesthesiaExisting treatment, for comparison

  Trephination and tumour resection are performed without any additional neuro-psychological monitoring or brain mapping, guided by STEALTH-neuronavigation.