RecruitingNot ApplicableNCT04266977

Restrictive Use of Dexamethasone in Glioblastoma


Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

50 participants

Start Date

May 8, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether patients with newly diagnosed glioblastoma (a serious type of brain tumor) who do not have significant brain swelling or midline shift can safely undergo surgery without the routine use of dexamethasone (a steroid), to reduce steroid-related side effects. **You may be eligible if:** - You are between 18 and 90 years old - You have a new contrast-enhancing brain lesion suspicious for glioblastoma that can be surgically removed - You have minimal brain midline shift (3mm or less) - Your neurological exam and consciousness are essentially normal (GCS of 14 or higher) **You may NOT be eligible if:** - Your tumor is in the back of the brain, brainstem, or you have multiple tumors - You have already been on steroids for more than one day before enrollment - You need steroids for another medical condition - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDexamethasone

restrictive use of DEX, based on standardized clinical and radiological criteria.


Locations(4)

Kantonsspital St. Gallen

Sankt Gallen, St.Gallen, Switzerland

Universitätsspital Basel

Basel, Switzerland

Department of Neurosurgery

Bern, Switzerland

Universitätsspital Zürich

Zurich, Switzerland

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NCT04266977


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