Ignite Creation Date:
2024-05-06 @ 12:51 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03861299
Status:
RECRUITING
Last Update Posted:
2023-11-21
First Post:
2019-02-28
Brief Title:
The SAFE-Trial Awake Craniotomy Versus Surgery Under General Anesthesia for Glioblastoma Patients
Sponsor:
Jasper Gerritsen
Organization:
Erasmus Medical Center
Study Overview
Official Title:
The SAFE-Trial Safe Surgery for Glioblastoma Multiforme Awake Craniotomy Versus Surgery Under General Anesthesia A Multicenter Prospective Randomised Controlled Study
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAFE
Brief 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 11 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have to be histologically confirmed If GBM is not histologically confirmed patients will be considered off-study and withdrawn from the study These patients will be followed-up according to standard practice Thereafter patients will receive the standard treatment with concomitant Temozolomide 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
Detailed Description:
Rationale Glioblastoma Multiforme GBM or Astrocytomas grade IV WHO are devastating tumors with one of the worst prognoses in oncology Extending resection improves survival in patients with GBM Surgery of GBM nowadays is usually performed under general anesthesia GA and resections are not as aggressive as possible due to the chance of seriously damaging the patient with a rather low life expectancy A surgical technique optimizing resection of the tumor in eloquent areas but preventing neurological deficits is necessary to improve survival and quality of life in these patients Awake craniotomy AC with the use of cortical and subcortical stimulation is an alternative surgical technique that is standardly implemented in surgery for low grade glioma but not yet for GBM AC has shown to increase resection percentage and preserve quality of life in low grade glioma LGG and could be of important value in the surgery of GBM
Objective The study is performed to increase safety and efficacy during surgery in patients with GBM in eloquent areas This study will compare awake craniotomy with surgery under general anesthesia for patients with GBM near or in eloquent areas Primary end points are 1 Proportion of patients with NIH Stroke Scale NIHSS 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 Secondary end points are 1 Health related quality of life HRQoL at 6 weeks 3 months and 6 months after operation 2 Progression-free survival PFS at 12 months after operation 3 Overall survival OS at 12 months after operation 4 Frequency and severity of Serious Adverse Effects in each group Infections intracranial bleeding epilepsy aphasia paresisparalysis in arms orand legs Also a cost benefit analysis will be performed
Study design The trial is set up as a multicenter randomized controlled study The study will include 246 patients in 5 neurosurgical centers in the Netherlands Patients with GBM in eloquent areas on diagnostic MRI will be selected by the neurosurgeons according to the eligibility criteria After informed consent the patient will be randomized for awake craniotomy AC or regular craniotomy under general anesthesia GA with 11 allocation ratio After surgery only patients with histologically proven GBM will continue with the study Patients in whom no GBM could not be proven histologically will be considered off-study Thereafter patients will receive the standard treatment with concomitant Temozolomide and radiation therapy and standard follow up Total duration of the study is 5 years Patient inclusion is 4 years Follow-up is 1 year
Study population Patients aged 18-90 years old with Glioblastoma Multiforme near or in eloquent areas and eligible for awake craniotomy
Intervention Awake craniotomy compared to craniotomy under general anaesthesia
Main study parametersendpoints
1 Proportion of patients with NIHSS deterioration at 6 weeks post-surgery
2 Proportion of patients without residual contrast-enhancing tumour on postoperative MRI
Nature and extent of the burden and risks associated with participation benefit and group relatedness Patients have 50 chance to be randomized for an awake procedure The risk-benefit-ratio of this procedure in patients with GBM is subject of this trial and the investigators expect less neurological morbidity than surgery under generalised anaesthesia Three quality of life questionnaires and 1 neurological examination will take place preoperatively 6 weeks after 3 months after and 6 months after the surgery The burden of this trial for the patient is therefore confined
Objective The study is performed to increase safety and efficacy during surgery in patients with GBM in eloquent areas This study will compare awake craniotomy with surgery under general anesthesia for patients with GBM near or in eloquent areas Primary end points are 1 Proportion of patients with NIH Stroke Scale NIHSS 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 Secondary end points are 1 Health related quality of life HRQoL at 6 weeks 3 months and 6 months after operation 2 Progression-free survival PFS at 12 months after operation 3 Overall survival OS at 12 months after operation 4 Frequency and severity of Serious Adverse Effects in each group Infections intracranial bleeding epilepsy aphasia paresisparalysis in arms orand legs Also a cost benefit analysis will be performed
Study design The trial is set up as a multicenter randomized controlled study The study will include 246 patients in 5 neurosurgical centers in the Netherlands Patients with GBM in eloquent areas on diagnostic MRI will be selected by the neurosurgeons according to the eligibility criteria After informed consent the patient will be randomized for awake craniotomy AC or regular craniotomy under general anesthesia GA with 11 allocation ratio After surgery only patients with histologically proven GBM will continue with the study Patients in whom no GBM could not be proven histologically will be considered off-study Thereafter patients will receive the standard treatment with concomitant Temozolomide and radiation therapy and standard follow up Total duration of the study is 5 years Patient inclusion is 4 years Follow-up is 1 year
Study population Patients aged 18-90 years old with Glioblastoma Multiforme near or in eloquent areas and eligible for awake craniotomy
Intervention Awake craniotomy compared to craniotomy under general anaesthesia
Main study parametersendpoints
1 Proportion of patients with NIHSS deterioration at 6 weeks post-surgery
2 Proportion of patients without residual contrast-enhancing tumour on postoperative MRI
Nature and extent of the burden and risks associated with participation benefit and group relatedness Patients have 50 chance to be randomized for an awake procedure The risk-benefit-ratio of this procedure in patients with GBM is subject of this trial and the investigators expect less neurological morbidity than surgery under generalised anaesthesia Three quality of life questionnaires and 1 neurological examination will take place preoperatively 6 weeks after 3 months after and 6 months after the surgery The burden of this trial for the patient is therefore confined
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MEC-2018-1564 | OTHER | Medical Ethical Committee Erasmus MC | None |