NCT04266977 Restrictive Use of Dexamethasone in Glioblastoma
| NCT ID | NCT04266977 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Glioblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2020-05-08 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2020-05-08 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Andreas Raabe, MD
PRINCIPAL INVESTIGATOR
Inselspital Bern, Department of Neurosurgery
Frequently Asked Questions
Who can join the NCT04266977 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Glioblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04266977 currently recruiting?
Yes, NCT04266977 is actively recruiting participants. Contact the research team at johannes.goldberg@insel.ch for enrollment information.
Where is the NCT04266977 trial being conducted?
This trial is being conducted at Sankt Gallen, Switzerland, Basel, Switzerland, Bern, Switzerland, Zurich, Switzerland.
Who is sponsoring the NCT04266977 clinical trial?
NCT04266977 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Andreas Raabe, MD at Inselspital Bern, Department of Neurosurgery. The trial plans to enroll 50 participants.
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