NCT03861299 The SAFE-Trial: Awake Craniotomy Versus Surgery Under General Anesthesia for Glioblastoma Patients.
| NCT ID | NCT03861299 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jasper Gerritsen |
| Condition | Glioblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 246 participants |
| Start Date | 2019-04-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 246 participants in total. It began in 2019-04-01 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 If GBM is not histologically confirmed, patients will be considered off-study and withdrawn from the study.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.
Eligibility 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
Contact & Investigator
Arnaud Vincent, MD PhD
PRINCIPAL INVESTIGATOR
Erasmus Medical Center
Frequently Asked Questions
Who can join the NCT03861299 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Glioblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03861299 currently recruiting?
Yes, NCT03861299 is actively recruiting participants. Contact the research team at j.gerritsen@erasmusmc.nl for enrollment information.
Where is the NCT03861299 trial being conducted?
This trial is being conducted at Ghent, Belgium, Tilburg, Netherlands, Rotterdam, Netherlands, The Hague, Netherlands and 1 additional location.
Who is sponsoring the NCT03861299 clinical trial?
NCT03861299 is sponsored by Jasper Gerritsen. The principal investigator is Arnaud Vincent, MD PhD at Erasmus Medical Center. The trial plans to enroll 246 participants.
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