Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
ID04266977

Restrictive Use of Dexamethasone in Glioblastoma from Referral to Discharge

Led by Insel Gruppe AG, University Hospital Bern · Updated on 2025-07-09

50

Participants Needed

4

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Glioblastoma (GBM) is a common and aggressive brain tumor in adults with a poor outlook despite intensive treatment. Steroids like dexamethasone (DEX) are commonly used throughout GBM care to reduce brain swelling and manage symptoms, but they may cause serious side effects that could negatively impact patient survival. This trial aims to evaluate if selected GBM patients can be safely managed with a restrictive use of DEX, limiting steroid exposure from referral to the neurosurgical center until discharge. Participants will follow a restrictive DEX regimen, where steroids are stopped immediately after study inclusion unless specific failure criteria occur. These criteria include worsening neurological status or increased brain swelling requiring surgical intervention. If these signs appear, DEX treatment will be started. The study observes patients from referral through their hospital discharge, with optional single-dose DEX during surgery if necessary. Throughout the study, patients receive clinical monitoring to track neurological function and brain imaging to assess tumor and edema volumes. Outcomes include the rate of failure of the restrictive regimen within 30 days after surgery, neurological or systemic complications, steroid dosage, and timing of additional treatments. The study also evaluates brain swelling and tumor size changes before and after surgery, along with the need for reoperations. Participants are followed closely to understand the safety and effects of limiting steroid use in GBM care.

CONDITIONS

Brief 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, suitable for surgical removal
  • Age between 18 and 90 years
  • Midline brain shift of 3 millimeters or less
  • Glasgow Coma Scale score of 14 or higher
  • National Institutes of Health Stroke Scale score of 3 or less
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Lesions located in the infratentorial region, brainstem, or multifocal lesions
  • Steroid treatment for more than one day before study inclusion
  • Need for steroid treatment due to other diseases
  • Contraindications to dexamethasone use
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - From referral to neurosurgical center until discharge

Participants follow a restrictive dexamethasone (DEX) regimen from referral to the neurosurgical center until discharge. Steroids are stopped immediately after study inclusion unless a failure criterion occurs, at which point DEX treatment is initiated.

Clinical follow-up visits until discharge

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

N

Nicole Söll, CDM

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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Published Research Related To This Trial

Dexamethasone administration during definitive radiation and temozolomide renders a poor prognosis in a retrospective analysis of newly diagnosed glioblastoma patients.

Lisa B E Shields, Brent J Shelton, Andrew J Shearer...

https://pubmed.ncbi.nlm.nih.gov/26520780