NCT03861299Recruiting
The SAFE-Trial: Awake Craniotomy Versus Surgery Under General Anesthesia for Glioblastoma Patients.
The SAFE-Trial: Safe Surgery for Glioblastoma Multiforme: Awake Craniotomy Versus Surgery Under General Anesthesia. A Multicenter Prospective Randomised Controlled Study
Source: ClinicalTrials.gov · Last updated 21 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 If GBM is not histologically confirmed, patients will be considered off-study and withdrawn from the study.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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 246 (estimated)
- First submitted
- 28 Feb 2019
- Start date
- 1 Apr 2019
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Jasper Gerritsen
- Diseases
- Glioblastoma
- NCT number
- NCT03861299
What you commit to
- Study type: Interventional
- Planned participants: 246
- From 1 Apr 2019 to the primary completion date, 1 Sept 2026
- 5 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous brain tumour surgery
- Previous low-grade glioma.
Other illness
- Substantial non-contrast enhancing tumor areas suggesting low grade gliomas with malignant transformation
- Psychiatric history
- 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.
Other
- Tumors of the cerebellum, brain stem or midline
- Multifocal contrast enhancing lesions
- Medical reasons precluding MRI (eg, pacemaker)
- Inability to give consent because of or language barrier
- Severe aphasia or dysphasia
Who the study is looking for
- 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
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Ghent Coordinator of this site? Confirm its status | Ghent | Belgium | Recruiting |
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| Erasmus MC Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Medical Center Haaglanden Coordinator of this site? Confirm its status | The Hague | Netherlands | Recruiting |
| Elisabeth-Tweesteden Ziekenhuis Coordinator of this site? Confirm its status | Tilburg | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.