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JOURNAL ONKOLOGIE – STUDIE
RESDEX

Restrictive Use of Dexamethasone in Glioblastoma

Rekrutierend

NCT-Nummer:
NCT04266977

Studienbeginn:
Mai 2020

Letztes Update:
24.03.2023

Wirkstoff:
Dexamethasone

Indikation (Clinical Trials):
Glioblastoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital Inselspital, Berne

Collaborator:
-

Studienleiter

Andreas Raabe, MD
Principal Investigator
Inselspital Bern, Department of Neurosurgery

Kontakt

Studienlocations
(3 von 4)

Department of Neurosurgery
3010 Bern
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Johannes Goldberg, MD
Phone: +41316322409
E-Mail: johannes.goldberg@insel.ch

Nicole Söll, CDM
Phone: +41316323164
E-Mail: nicole.soell@insel.ch» Ansprechpartner anzeigen
Universitätsspital Zürich
8091 Zürich
SwitzerlandNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Vincens Kälin, MD
E-Mail: Vincens.Kaelin@usz.ch

Carki Serra, MD
E-Mail: Carlo.Serra@usz.ch» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Detailed Description:

Background

Glioblastoma (GBM) is the most common and devastating malignant brain tumor in adults.

Patients with glioblastoma face a poor prognosis. Despite maximal treatment, most patients

suffer tumor progression after 6-7 months and die within 1-2 years. Standard treatment for

newly diagnosed glioblastoma contains maximal safe surgery and adjuvant radiochemotherapy

with temozolomide. Additional administration of steroids has established as standard of care

during treatment of GBM. It is widely used during the entire course of the disease including

pre- and postoperative management, chemotherapy and radiotherapy. Dexamethasone (DEX) is the

most frequently used steroid. The main purpose is to reduce the tumor associated vasogenic

cerebral edema, to prevent or treat increased intracranial pressure. In addition, DEX helps

to cope with adverse effects of GBM-treatment like nausea, vomiting and fatigue. However,

steroids are also linked to a multitude of adverse side effects that may affect the survival

of GBM patients such as major immunosuppression, and metabolic changes like hyperglycemia.

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.

DEX was also related to a poor prognosis in recurrent GBM. Despite these findings, in routine

clinical practice, the suspicion of glioblastoma often triggers the administration of DEX,

regardless of neurologic symptoms or the extension of cerebral edema. Many patients are

treated with larger doses of DEX per day before being referred to a neurosurgical center and

are kept on steroids during the entire treatment. On the other hand, the clinical experience

shows that GBM-patients with no, or only mild neurologic symptoms, normal intracranial

pressure and relatively small cerebral edema can be managed without administration of DEX.

The rationale for this study is to objectify the criteria and safety of a restrictive DEX

regimen (based on standardized clinical and radiological criteria). A restrictive DEX regimen

may help to reduce over-use, limit the number of patients exposed to the adverse effects of

DEX, and potentially improve survival in GBM-patients. 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.

Objective

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.

Methods

All patients referred to the neurosurgical center with suspicion of glioblastoma are screened

for inclusion- and exclusion criteria. If eligible and consenting of the patient to the study

protocol, no steroids will be administered until discharge (except optional intraoperative

single shot dexamethasone of max. 4mg if necessary). If steroids have been administered for a

maximum of one day before referral, they will be stopped immediately. Patients are followed

clinically. If one of the above-described failure criteria occurs, the primary endpoint is

reached and DEX will be administered.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Failure rate of the restrictive DEX regimen (Time Frame - 30 days after surgery):
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



Secondary outcome:

1. Secondary neurological or systemic complication (Time Frame - 30 days after surgery):
Secondary neurological or systemic complication resulting in a 30-day morbidity or mortality

2. Cumulative dexamethasone dosage (Time Frame - 30 days after surgery):
Cumulative dexamethasone dosage during study period

3. National Institutes of Health Stroke Scale (NIHSS) over time of the study period (Time Frame - 30 days after surgery):
NIHSS over time of the study period and correlation with steroid medication (Score 0-42, 0 = no deficits and 1-42 deficits)

4. Glasgow Coma Scale (GCS) over time of the study period and correlation with steroid medication (Time Frame - 30 days after surgery):
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)

5. Volume of contrast enhancing tumor on preoperative MRI (Time Frame - presurgery):
Volume of contrast enhancing tumor on preoperative MRI

6. Volume of contrast enhancing tumor on postoperative MRI (Time Frame - 48 hours after surgery):
Volume of contrast enhancing tumor on postoperative MRI

7. Volume of edema on preoperative MRI and correlation with steroid medication (Time Frame - presurgery):
Volume of edema on preoperative MRI and correlation with steroid medication

8. Volume of edema on postoperative MRI (Time Frame - 48 hours after surgery):
Volume of edema on postoperative MRI and correlation with steroid medication

9. Time to start of adjuvant treatment (Time Frame - 30 days after surgery):
Time to start of adjuvant treatment

10. Rate of reoperations (Time Frame - 30 days after surgery):
Rate of reoperations

11. Cause of reoperations (Time Frame - 30 days after surgery):
Cause of reoperations

Geprüfte Regime

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

Quelle: ClinicalTrials.gov


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