Restrictive Use of Dexamethasone in Glioblastoma

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Switzerland
Universitätsspital Basel
NOT_YET_RECRUITING
Basel
Department of Neurosurgery
RECRUITING
Bern
Kantonsspital St. Gallen
NOT_YET_RECRUITING
Sankt Gallen
Universitätsspital Zürich
NOT_YET_RECRUITING
Zurich
Contact Information
Primary
Johannes Goldberg, MD
johannes.goldberg@insel.ch
+41316322409
Backup
Nicole Söll, CDM
nicole.soell@insel.ch
+41316323164
Time Frame
Start Date: 2020-05-08
Estimated Completion Date: 2028-04
Participants
Target number of participants: 50
Treatments
Experimental: Treatment Dexamethasone
The restrictive DEX regimen is applied from referral to the neurosurgical center until discharge. All administered steroids will be stopped immediately after study inclusion.~If one or more of the previously defined failure criteria occurs, patients will be treated with DEX.
Sponsors
Leads: Insel Gruppe AG, University Hospital Bern

This content was sourced from clinicaltrials.gov