Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
NCT04266977

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

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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Restrictive Use of Dexamethasone in Glioblastoma | DecenTrialz