Actively Recruiting
Led by Jasper Gerritsen · Updated on 2023-11-21
246
Participants Needed
5
Research Sites
52 weeks
Total Duration
J
Jasper Gerritsen
Lead Sponsor
E
Elisabeth-TweeSteden Ziekenhuis
Collaborating Sponsor
Researchers are evaluating surgical approaches for patients with Glioblastoma Multiforme (GBM) located in critical brain areas responsible for movement and language. This trial compares awake craniotomy, which uses direct brain stimulation during surgery to identify and protect vital functions, with traditional craniotomy performed under general anesthesia. GBM is a severe brain tumor with poor prognosis, and improving surgical safety and tumor removal could impact survival and quality of life. Participants are randomly assigned to either awake craniotomy or surgery under general anesthesia with equal chance. In awake craniotomy, surgeons use electrical stimulation to map brain areas during surgery, working with neuropsychologists to monitor speech and movement. Surgery under general anesthesia is guided by neuronavigation without brain mapping. After surgery, only patients with confirmed GBM continue in the study and receive standard treatment including chemotherapy with Temozolomide and radiation therapy. During the study, neurological function is assessed before surgery and at 6 weeks post-operation using the NIH Stroke Scale. Brain scans within 48 hours after surgery measure the amount of tumor removed. Quality of life is evaluated at multiple time points up to 6 months, and survival, tumor progression, and serious side effects are tracked for 12 months. The total study lasts 5 years, including patient recruitment over 4 years and 1 year of follow-up after surgery.
CONDITIONS
The SAFE-Trial: Awake Craniotomy Versus Surgery Under General Anesthesia for Glioblastoma Patients.
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo either awake craniotomy with brain mapping or craniotomy under general anesthesia to remove the glioblastoma tumor.
1 surgical visit
Duration - Up to 6 months
Participants are monitored for neurological outcomes, tumor resection success, and adverse events after surgery. Quality of life and neurological assessments are performed at multiple time points.
Follow-up visits at 6 weeks, 3 months, and 6 months post-surgery
Duration - Up to 12 months after surgery
Participants are followed for progression-free survival and overall survival with standard treatment and routine care.
Periodic assessments as per standard care
Total: 5 locations
1
University Hospital Ghent
Ghent, Belgium, 9000
Actively Recruiting
2
Elisabeth-Tweesteden Ziekenhuis
Tilburg, North Brabant, Netherlands, 5022 GC
Actively Recruiting
3
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015 CE
Actively Recruiting
4
Medical Center Haaglanden
The Hague, South Holland, Netherlands, 2261 CP
Actively Recruiting
5
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
Actively Recruiting
J
Jasper Gerritsen, MD PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Jasper K W Gerritsen, Rosa H Zwarthoed, John L Kilgallon...
https://pubmed.ncbi.nlm.nih.gov/35569489Jasper Kees Wim Gerritsen, Clemens Maria Franciscus Dirven, Steven De Vleeschouwer...
https://pubmed.ncbi.nlm.nih.gov/34290067Jasper K W Gerritsen, Markus Klimek, Clemens M F Dirven...
https://pubmed.ncbi.nlm.nih.gov/31676314