Restricting Dexamethasone Use in Glioblastoma Treatment
Restrictive Use of Dexamethasone in Glioblastoma
NA · Insel Gruppe AG, University Hospital Bern · NCT04266977
This study is testing if newly diagnosed glioblastoma patients can do well without the usual steroid treatment to see if it helps them avoid side effects and improve their outcomes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern (other) |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Sankt Gallen, St.Gallen and 3 other locations) |
| Trial ID | NCT04266977 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety of limiting the use of dexamethasone, a steroid commonly administered to glioblastoma patients, during their treatment. It aims to determine if selected patients can be treated effectively without the standard steroid regimen, which is associated with adverse side effects and poor prognostic outcomes. The study focuses on newly diagnosed glioblastoma patients who meet specific criteria, including age and neurological status, and excludes those with certain conditions or prior steroid use. By assessing the impact of reduced steroid use, the study seeks to improve patient outcomes and survival rates.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 90 with newly diagnosed glioblastoma and specific neurological criteria.
Not a fit: Patients with infratentorial lesions, multifocal lesions, or those requiring steroids for other conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates and reduced side effects for glioblastoma patients.
How similar studies have performed: While the use of dexamethasone in glioblastoma treatment is standard, this study's approach to restrict its use is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sankt Gallen, St.Gallen and 3 other locations
- Kantonsspital St. Gallen — Sankt Gallen, St.Gallen, Switzerland (NOT_YET_RECRUITING)
- Universitätsspital Basel — Basel, Switzerland (NOT_YET_RECRUITING)
- Department of Neurosurgery — Bern, Switzerland (RECRUITING)
- Universitätsspital Zürich — Zurich, Switzerland (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Andreas Raabe, MD — Inselspital Bern, Department of Neurosurgery
- Study coordinator: Johannes Goldberg, MD
- Email: johannes.goldberg@insel.ch
- Phone: +41316322409
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Glioblastoma, Dexamethasone, Steroids