Glioblastoma Clinical Trial
— RESDEXOfficial title:
Restrictive Use of Dexamethasone in Glioblastoma
NCT number | NCT04266977 |
Other study ID # | RESDEX |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 8, 2020 |
Est. completion date | April 2026 |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | April 2026 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Universitätsspital Basel | Basel | |
Switzerland | Department of Neurosurgery | Bern | |
Switzerland | Kantonsspital St. Gallen | Saint Gallen | St.Gallen |
Switzerland | Universitätsspital Zürich | Zürich |
Lead Sponsor | Collaborator |
---|---|
Insel Gruppe AG, University Hospital Bern |
Switzerland,
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Failure rate of the restrictive DEX regimen | Failure rate of the restrictive DEX regimen, defined as cerebral edema or mass effect causing any of the following: GCS deterioration = 2 points or NIHSS increase = 3 points or Increase of midline Shift = 2mm or any new herniation sign on imaging or Any surgical rescue procedure for increasing mass effect (hemicraniectomy, removal of bone flap, abortion of the procedure or emergency tumor debulking | 30 days after surgery | |
Secondary | Secondary neurological or systemic complication | Secondary neurological or systemic complication resulting in a 30-day morbidity or mortality | 30 days after surgery | |
Secondary | Cumulative dexamethasone dosage | Cumulative dexamethasone dosage during study period | 30 days after surgery | |
Secondary | National Institutes of Health Stroke Scale (NIHSS) over time of the study period | NIHSS over time of the study period and correlation with steroid medication (Score 0-42, 0 = no deficits and 1-42 deficits) | 30 days after surgery | |
Secondary | Glasgow Coma Scale (GCS) over time of the study period and correlation with steroid medication | GCS over time of the study period and correlation with steroid medication GCS over time of the study period and correlation with steroid medication (Score 15-3, 15 = patient is fully oriented, 3 = patient is intubated) | 30 days after surgery | |
Secondary | Volume of contrast enhancing tumor on preoperative MRI | Volume of contrast enhancing tumor on preoperative MRI | presurgery | |
Secondary | Volume of contrast enhancing tumor on postoperative MRI | Volume of contrast enhancing tumor on postoperative MRI | 48 hours after surgery | |
Secondary | Volume of edema on preoperative MRI and correlation with steroid medication | Volume of edema on preoperative MRI and correlation with steroid medication | presurgery | |
Secondary | Volume of edema on postoperative MRI | Volume of edema on postoperative MRI and correlation with steroid medication | 48 hours after surgery | |
Secondary | Time to start of adjuvant treatment | Time to start of adjuvant treatment | 30 days after surgery | |
Secondary | Rate of reoperations | Rate of reoperations | 30 days after surgery | |
Secondary | Cause of reoperations | Cause of reoperations | 30 days after surgery |
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