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NCT04266977Recruiting

Restrictive Use of Dexamethasone in Glioblastoma

Summary

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 criteria

• 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 criteria

• 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

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
No phase (N/A)
Study type
Interventional
Countries
Switzerland
Sponsor
Insel Gruppe AG, University Hospital Bern(Other)
Protocol no.
RESDEX
Conditions
Glioblastoma, Dexamethasone, Steroids
Interventions
Drug

Treatments studied

  • Dexamethasone

Locations · 1

  • Bern, SwitzerlandDepartment of NeurosurgeryRecruiting at this site

In total, worldwide, 1 of the 4 sites listed in the registry is recruiting; the other 3 are not currently recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: July 9, 2025).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.