No registrations found.
ID
Source
Brief title
Health condition
Glioblastoma
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks post-surgery, where deterioration is defined as at least one point increase in total NIHSS score compared to baseline
2. Proportion of patients without residual contrast-enhancing tumour on postoperative MRI, where residual tumour is defined as contrast-enhancement with a volume more than 0.175 cm3.
Secondary outcome
1. Health related quality of life (HRQoL) at 6 weeks, 3 and 6 months after operation, where HRQol is measured with the QLQ-C30, QLQ-BN20 and EQ-5D questionnaires.
2. Progression-free survival (PFS) at 12 months 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.
3. Overall survival (OS) at 12 months defined as time from diagnosis to death from any cause.
4. Frequency and severity of Serious Adverse Effects in each group: Infections, intracerebral bleeding, epilepsy, aphasia, paresis/paralysis in arms or/and legs.
Background summary
The trial is designed as a multicenter randomized controlled study. 246 patients with presumed Glioblastoma Multiforme in eloquent areas on diagnostic MRI will be selected by the neurosurgeons according the eligibility criteria (see under). After written informed consent is obtained, the patient will be randomized for an awake craniotomy (AC) (+/-123 patients) or craniotomy under general anesthesia (GA) (+/-123 patients), with 1:1 allocation ratio. Under GA the amount of resection of the tumour has to be performed within safe margins as judged by the surgeon during surgery. The second group will be operated with an awake craniotomy procedure where the resection boundaries for motor or language functions will be identified by direct cortical and subcortical stimulation. After surgery, the diagnosis of GBM will have to be histologically confirmed. If GBM is not histologically confirmed, patients will be considered off-study and withdrawn from the study. These patients will be followed-up according to standard practice. Thereafter, patients will receive the standard treatment with concomitant Temozolamide and radiation therapy and standard follow up. Total duration of the study is 5 years. Patient inclusion is expected to take 4 years. Follow-up is 1 year after surgery. Statistical analysis, cost benefit analysis and article writing will take 3 months.
Study objective
Awake craniotomy improves safety and efficacy during surgery for glioblastoma in eloquent areas
Study design
Baseline - 48 hours postoperatively - 6 weeks postoperatively - 3 months postoperatively - 6 months postoperatively
Intervention
Awake craniotomy; craniotomy under general anesthesia; NIHSS; EQ-5D; EORTC QLQ-C30; EORTC QLQ-BN20
Inclusion criteria
1. Age ≥18 years and ≤ 90 years
2. 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
3. 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) [47]
4. The tumor is suitable for resection (according to neurosurgeon)
5. Karnofsky performance scale 80 or more
6. No severe aphasia or dysphasia; able to communicate during an awake procedure
7. Written Informed consent
Exclusion criteria
1. Tumors of the cerebellum, brain stem or midline
2. Multifocal contrast enhancing lesions
3. Substantial non-contrast enhancing tumor areas suggesting low grade gliomas with malignant transformation
4. Medical reasons precluding MRI (eg, pacemaker)
5. Inability to give consent because of or language barrier
6. Psychiatric history
7. Previous brain tumour surgery
8. Previous low-grade glioma.
9. 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.
10. Severe aphasia or dysphasia
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 | NL7589 |
| Other | METC EMC : MEC-2018-1564 |