No registrations found.
ID
Source
Brief title
Health condition
Glioblastoma
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postoperative neurological complications; extent of resection
Secondary outcome
Overall survival; progression-free survival; onco-functional outcome
Background summary
Background
The main surgical dilemma during glioblastoma resections is the surgeon’s inability to accurately identify eloquent areas when the patient is under general anesthesia (GA) without mapping techniques. Intraoperative stimulation mapping (ISM) techniques can be used to maximize extent of resection in eloquent areas yet simultaneously minimze the risk of postoperative neurological deficits. ISM has been widely implemented for low-grade glioma resections (LGG) backed with ample scientific evidence, but this is not yet the case for glioblastoma resections. Therefore, ISM could thus be of important value in glioblastoma surgery to improve both surgical and clinical outcomes.
Methods/Design
This study is a international, multicenter, prospective 3-arm non-randomized clinical trial. Consecutive glioblastoma patients will receive tumor resection with awake mapping, asleep mapping or no mapping with a 1:1:1 allocation ratio.
Primary endpoints are: 1) Proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks after surgery and 2) Extent of resection as assessed by a neuroradiologist on postoperative contrast MRI scans. Secondary endpoints are: 1) Overall survival (OS); 2) Progression-free survival (PFS) at 6 months and 12 months after surgery and 3) Frequency and severity of Serious Adverse Events (SAEs) in each arm. Total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.
Discussion
The present study should demonstrate whether awake mapping, asleep mapping or no mapping is superior regarding neurological morbidity, survival and quality of life for glioblastoma resections and which subgroups yield the most benefit from which surgical modality.
Study objective
ISM yields superior clinical outcomes as compared to resection under general anesthesia for glioblastoma patients
Study design
Baseline, 6 weeks, 3 months, 6 months
Intervention
Awake mapping (awake craniotomy)
Asleep mapping
Inclusion criteria
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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8998 |
| Other | METC Erasmus MC : MEC-2020-0812 |