Restrictive Use of Dexamethasone in Glioblastoma
Recruiting now · Not applicable
Conditions studied: Glioblastoma, Dexamethasone, Steroids
In brief
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.
Key facts
- Study ID
- NCT04266977
- Run by
- Insel Gruppe AG, University Hospital Bern
- People needed
- 50
- Starts
- 2020-05-08
- Expected to finish
- 2028-04-01
- Last updated by the study team
- 2025-07-09
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Department of Neurosurgery — Bern, Switzerland (enrolling)
- Kantonsspital St. Gallen — Sankt Gallen, St.Gallen, Switzerland
- Universitätsspital Basel — Basel, Switzerland
- Universitätsspital Zürich — Zurich, Switzerland
Full record on ClinicalTrials.gov
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