ISM yields superior clinical outcomes as compared to resection under general anesthesia for glioblastoma patients
ID
Bron
Verkorte titel
Aandoening
Glioblastoma
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Postoperative neurological complications; extent of resection
Achtergrond van het onderzoek
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.
Doel van het onderzoek
ISM yields superior clinical outcomes as compared to resection under general anesthesia for glioblastoma patients
Onderzoeksopzet
Baseline, 6 weeks, 3 months, 6 months
Onderzoeksproduct en/of interventie
Awake mapping (awake craniotomy)
Asleep mapping
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8998 |
| Ander register | METC Erasmus MC : MEC-2020-0812 |