Testing Limited Steroid Use in Patients With Glioblastoma
Tests whether dexamethasone can be given sparingly to adults with glioblastoma, a brain tumor.
Plain-language title generated from the registry record
Registry title: Restrictive Use of Dexamethasone in Glioblastoma
Key facts
- Where
- Basel, Bern, Sankt Gallen, and Zurich, SwitzerlandSee the 4 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 90 years old?
Source: NCT04266977, who can take part
Where in Switzerland
- Universitätsspital BaselBasel, SwitzerlandNot yet recruiting
- Department of NeurosurgeryBern, SwitzerlandTaking people
- Kantonsspital St. GallenSankt Gallen, SwitzerlandNot yet recruiting
- Universitätsspital ZürichZurich, SwitzerlandNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Insel Gruppe AG, University Hospital Bern
- Trial code
- NCT04266977
- Record updated
- 9 July 2025
- Original description
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.Read full original descriptionShow less
Restrictive Use of Dexamethasone in Glioblastoma
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.
Inclusion: 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; NIHSS ≤ 3; Provided written informed consent.
Exclusion: Therapy with steroids for >1 day before inclusion; Need for treatment with steroids due to any other disease; Contraindications to the administration of Dexamethasone; Infratentorial lesions, brainstem lesions, multifocal lesions; Pregnancy or breastfeeding.