Glioblastoma
Conditions
Brief summary
The study is designed as an international, multicenter prospective cohort study. Patients with presumed glioblastoma (GBM) in- or near eloquent areas on diagnostic MRI will be selected by neurosurgeons. Patients will be treated following one of three study arms: 1) a craniotomy where the resection boundaries for motor or language functions will be identified by the awake mapping technique (awake craniotomy, AC); 2) a craniotomy where the resection boundaries for motor functions will be identified by asleep mapping techniques (MEPs, SSEPs, continuous dynamic mapping); 3) a craniotomy where the resection boundaries will not be identified by any mapping technique (no mapping group). All patients will receive follow-up according to standard practice.
Interventions
PROCEDUREAwake mapping under local anesthesia
During an awake craniotomy, the patient is awake and cooperative during the resection of the tumor while the surgeon uses electro(sub)cortical mapping to prevent damage to eloquent areas.
During asleep mapping under general anesthesia, the surgeon uses electro(sub)cortical mapping with evoked potentials (MEPs, SSEPs or continuous dynamic mapping) to prevent damage to eloquent areas.
During resection under general anesthesia without mapping, the surgeon does not use any intraoperative stimulation mapping techniques to identify eloquent areas.
Sponsors
Medical Center Haaglanden
Universitaire Ziekenhuizen KU Leuven
University of California, San Francisco
Erasmus Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years and ≤ 90 years 2. Tumor diagnosed as GBM on MRI as assessed by the neurosurgeon 3. Tumors situated in or near eloquent areas; motor cortex, sensory cortex, subcortical pyramidal tract, speech areas or visual areas as indicated on MRI (Sawaya Grading II and II) 4. The tumor is suitable for resection (according to neurosurgeon) 5. Written informed consent
Exclusion criteria
1. Tumors of the cerebellum, brain stem or midline 2. Multifocal contrast enhancing lesions 3. Medical reasons precluding MRI (e.g. pacemaker) 4. Inability to give written informed consent (e.g. because of severe language barrier) 5. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurological morbidity | Between baseline and 6 weeks/3 months/6 months postoperatively | NIHSS deterioration of 1 point or more as compared to baseline value. |
| Extent of resection | Assessed within 72 hours on postoperative MRI scan | Resection percentage as assessed by an independent neuroradiologist on MRI contrast images with volumetric analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Onco-functional outcome | Between baseline and 6 weeks/3 months/6 months postoperatively | 2D coordinate based on extent of resection (or residual tumor volume) on the x-axis and NIHSS score on the y-axis |
| Frequency and severity of Serious Adverse Events (SAEs) | Between surgery and 6 weeks postoperatively | Infections, intracerebral bleeding, epilepsy, aphasia, paresis/paralysis in arms or/and legs (this is not an exhaustive list). |
| Progression-free survival | Between surgery and 12 months postoperatively | Progression-free survival (PFS) defined as time from diagnosis to disease progression (occurrence of a new tumour lesion with a volume greater than 0.175 cm³, or an increase in residual tumour volume of more than 25%) or death, whichever comes first. |
| MRC deterioration (for motor gliomas) | Between baseline and 6 weeks/3 months/6 months postoperatively | MRC deterioration of 1 point or more as compared to baseline value. |
| Residual tumor volume | Assessed within 72 hours on postoperative MRI scan | Postoperative tumor volume in mm3 as assessed by an independent neuroradiologist on MRI contrast images with volumetric analysis |
| Overall survival | Between surgery and 12 months postoperatively | Overall survival (OS) defined as time from diagnosis to death from any cause. |
Countries
Belgium, Germany, Netherlands, Switzerland, United States
Contacts
Primary ContactJasper Gerritsen, MD
Backup ContactArnaud Vincent, MD PhD
Outcome results
None listed