Restrictive Use of Dexamethasone in Glioblastoma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Dexamethasone

    Drug

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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Treatment DexamethasoneExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
30 days after surgery

Secondary outcomes

1

Secondary neurological or systemic complication

Secondary neurological or systemic complication resulting in a 30-day morbidity or mortality

Time frame
30 days after surgery
2

Cumulative dexamethasone dosage

Cumulative dexamethasone dosage during study period

Time frame
30 days after surgery
3

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)

Time frame
30 days after surgery
4

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)

Time frame
30 days after surgery

Other outcomes

Sponsors and contacts

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