Status:
RECRUITING
The SAFE-Trial: Awake Craniotomy Versus Surgery Under General Anesthesia for Glioblastoma Patients.
Lead Sponsor:
Jasper Gerritsen
Collaborating Sponsors:
Elisabeth-TweeSteden Ziekenhuis
University Medical Center Groningen
Conditions:
Glioblastoma
Glioblastoma Multiforme
Eligibility:
All Genders
18-90 years
Phase:
NA
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 accordi...
Detailed Description
Rationale Glioblastoma Multiforme (GBM) or Astrocytoma's grade IV (WHO) are devastating tumors with one of the worst prognoses in oncology. Extending resection improves survival in patients with GBM. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT03861299
Start Date
April 1 2019
End Date
September 1 2027
Last Update
November 21 2023
Active Locations (5)
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1
University Hospital Ghent
Ghent, Belgium, 9000
2
Elisabeth-Tweesteden Ziekenhuis
Tilburg, North Brabant, Netherlands, 5022 GC
3
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015 CE
4
Medical Center Haaglanden
The Hague, South Holland, Netherlands, 2261 CP