Comparing awake craniotomy and general anesthesia for glioblastoma surgery
The SAFE-Trial: Safe Surgery for Glioblastoma Multiforme: Awake Craniotomy Versus Surgery Under General Anesthesia. A Multicenter Prospective Randomised Controlled Study
This study is testing whether having brain surgery while awake is safer and more effective than having it under general anesthesia for people with glioblastoma in important areas of the brain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 246 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 5 sites (Ghent and 4 other locations) |
| Trial ID | NCT03861299 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized controlled trial aims to evaluate the safety and efficacy of awake craniotomy versus surgery under general anesthesia in patients with Glioblastoma Multiforme located in eloquent brain areas. A total of 246 patients will be randomized into two groups: one undergoing awake craniotomy with cortical and subcortical stimulation, and the other receiving surgery under general anesthesia. The primary endpoints include the proportion of patients experiencing neurological deterioration post-surgery and the extent of tumor resection achieved. The study seeks to improve surgical outcomes and quality of life for patients with this aggressive brain tumor.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 with a confirmed diagnosis of Glioblastoma Multiforme located in or near eloquent brain areas.
Not a fit: Patients with tumors in the cerebellum, brain stem, or midline, or those with multifocal lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better surgical outcomes and improved quality of life for glioblastoma patients.
How similar studies have performed: Previous studies have shown that awake craniotomy can improve resection rates and preserve quality of life in low-grade gliomas, suggesting potential benefits for glioblastoma surgery as well.
Eligibility criteria
Show full inclusion / exclusion 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) 4. The tumor is suitable for resection (according to neurosurgeon) 5. Karnofsky performance scale 80 or more 6. Written Informed consent 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
Where this trial is running
Ghent and 4 other locations
- University Hospital Ghent — Ghent, Belgium (Recruiting)
- Elisabeth-Tweesteden Ziekenhuis — Tilburg, North Brabant, Netherlands (Recruiting)
- Erasmus MC — Rotterdam, South Holland, Netherlands (Recruiting)
- Medical Center Haaglanden — The Hague, South Holland, Netherlands (Recruiting)
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Arnaud Vincent, MD PhD — Erasmus Medical Center
- Study coordinator: Jasper Gerritsen, MD PhD
- Email: j.gerritsen@erasmusmc.nl
- Phone: +31629119553
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.