NCT04266977Recrutement en cours
Restrictive Use of Dexamethasone in Glioblastoma
Résumé
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.
Critères d'inclusion
• 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
Critères d'exclusion
• 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
Contacts
Les coordonnées de l'équipe de l'essai s'affichent sur demande.
Voir la fiche officielle de l'essai- Statut
- Recrutement en cours
- Phase
- Sans phase (N/A)
- Type d'étude
- Interventionnelle
- Pays
- Suisse
- Promoteur
- Insel Gruppe AG, University Hospital Bern(Autre)
- N° de protocole
- RESDEX
- Pathologies
- Glioblastoma, Dexamethasone, Steroids
- Interventions
- Médicament
Traitements évalués
- Dexamethasone
Lieux · 1
- Bern, SuisseDepartment of NeurosurgeryRecrute dans ce centre
Au total, dans le monde, 1 des 4 centres listés au registre recrute ; les 3 autres ne recrutent pas actuellement.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 9 juillet 2025).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
Voir aussi
Autres versions
Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.