About this trial
The administration of steroids, most commonly dexamethasone (DEX), has established as standard of care during treatment of glioblastoma (GBM) and is widely used during the entire course of the disease including pre- and postoperative management, chemo- and radiotherapy. The primary purpose is to reduce tumor-associated vasogenic edema and to prevent or treat increased intracranial pressure. However, steroids are also linked to a multitude of adverse side effects that may affect survival of GBM patients such as major immunosuppression. The use of steroids during radiotherapy is associated with reduced overall- and progression-free survival and has been identified as an independent poor prognostic factor. Despite these findings, the suspicion of GBM often triggers the administration of DEX in routine clinical practice, regardless of neurological symptoms, tumor size, or extension of cerebral edema. The purpose of this study is to assess whether selected GBM patients can be treated safely with a restrictive DEX regimen from referral to the neurosurgical center until discharge.
The primary objective is to determine the failure rate of a restrictive DEX regimen defined as edema or mass effect leading to any of the following: GCS deterioration ≥ 2 points, NIHSS increase ≥ 3 points, increase of midline Shift ≥ 2mm, or any surgical rescue procedure for increasing mass effect.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Newly diagnosed supratentorial contrast enhancing lesion suspicious of glioblastoma without major mass effect, amenable to surgical resection
Age 18 - 90 years
Midline Shift ≤ 3mm
GCS ≥ 14
Disqualifiers
Infratentorial lesions, brainstem lesions, multifocal lesions
Therapy with steroids for >1 day before inclusion
Need for treatment with steroids due to any other disease
Contraindications to the administration of Dexamethasone
Trial design
Single group
Treatments tested in this trial
Dexamethasone
Drugrestrictive use of DEX, based on standardized clinical and radiological criteria.
Treatment groups
Trial outcomes
Primary outcomes
Failure rate of the restrictive DEX regimen
Failure rate of the restrictive DEX regimen, defined as cerebral edema or mass effect causing any of the following: GCS deterioration ≥ 2 points or NIHSS increase ≥ 3 points or Increase of midline Shift ≥ 2mm or any new herniation sign on imaging or Any surgical rescue procedure for increasing mass effect (hemicraniectomy, removal of bone flap, abortion of the procedure or emergency tumor debulking
Secondary outcomes
Secondary neurological or systemic complication
Secondary neurological or systemic complication resulting in a 30-day morbidity or mortality
Cumulative dexamethasone dosage
Cumulative dexamethasone dosage during study period
National Institutes of Health Stroke Scale (NIHSS) over time of the study period
NIHSS over time of the study period and correlation with steroid medication (Score 0-42, 0 = no deficits and 1-42 deficits)
Glasgow Coma Scale (GCS) over time of the study period and correlation with steroid medication
GCS over time of the study period and correlation with steroid medication GCS over time of the study period and correlation with steroid medication (Score 15-3, 15 = patient is fully oriented, 3 = patient is intubated)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.