Actively Recruiting
Restrictive Use of Dexamethasone in Glioblastoma
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2025-07-09
50
Participants Needed
4
Research Sites
412 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Restrictive Use of Dexamethasone in Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed supratentorial contrast enhancing lesion suspicious of glioblastoma without major mass effect, amenable to surgical resection
- Age 18 - 90 years
- Midline Shift 3mm
- Glasgow Coma Scale (GCS) 14
- NIH Stroke Scale (NIHSS) 3
- Provided written informed consent
You will not qualify if you...
- 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
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Kantonsspital St. Gallen
Sankt Gallen, St.Gallen, Switzerland, 9007
Not Yet Recruiting
2
Universitätsspital Basel
Basel, Switzerland, 4031
Not Yet Recruiting
3
Department of Neurosurgery
Bern, Switzerland, 3010
Actively Recruiting
4
Universitätsspital Zürich
Zurich, Switzerland, 8091
Not Yet Recruiting
Research Team
J
Johannes Goldberg, MD
CONTACT
N
Nicole Söll, CDM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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