Trial comparing treatments for Glioblastoma
Official title The SAFE-Trial: Awake Craniotomy Versus Surgery Under General Anesthesia for Glioblastoma Patients.
ClinicalTrials.gov ID: NCT03861299
What this study is testing
- What it's testing
- This study aims to find out which type of brain surgery allows doctors to remove more tumor safely without causing new problems with movement or speech.
- Who it's for
- People who have a brain tumor called glioblastoma in an area that controls movement or speech.
- What's involved
- Participants will have brain surgery either while awake or under general anesthesia. After surgery, they will receive standard radiation and chemotherapy and have regular check-ups.
- Time commitment
- The study lasts about one year after surgery, which includes regular follow-up visits.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- 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...
- Tumors situated in or near eloquent areas; motor cortex, sensory cortex, subcortical pyramidal tract or speech areas as indicated on MRI (Sawaya...
- The tumor is suitable for resection (according to neurosurgeon)
- Karnofsky performance scale 80 or more
You likely can't join if
- 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
See the full 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 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Ghent, Belgium
- Tilburg, North Brabant, Netherlands
- Rotterdam, South Holland, Netherlands
- The Hague, South Holland, Netherlands
- Groningen, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Ghent, Belgium; Tilburg, North Brabant, Netherlands; Rotterdam, South Holland, Netherlands; The Hague, South Holland, Netherlands; Groningen, Netherlands. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.