The SAFE-Trial: Awake Craniotomy Versus Surgery Under General Anesthesia for Glioblastoma Patients.

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 wi

Trial Details

NCT ID
NCT03861299
Phase
NA
Sponsor
Jasper Gerritsen
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • Awake craniotomy
  • Craniotomy under general anesthesia
Locations (sample)
  • Ghent, Belgium|51.05,3.71667
  • Tilburg, North Brabant, Netherlands|51.55551,5.0913
  • Rotterdam, South Holland, Netherlands|51.9225,4.47917
  • The Hague, South Holland, Netherlands|52.07667,4.29861
  • Groningen, Netherlands|53.21917,6.56667

Key Eligibility 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 are…
  • Tumors situated in or near eloquent areas; motor cortex, sensory cortex, subcortical pyramidal tract or speech areas as indicated on MRI (Sawaya Gr…
  • The tumor is suitable for resection (according to neurosurgeon)

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

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