Restrictive Use of Dexamethasone in Glioblastoma

NCT04266977 | Recruiting DMC

• 1 other identifier: RESDEX
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Glioblastoma; Dexamethasone; Steroids

Outcome Measures

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

  30 days after surgery

Secondary Outcomes (11)

• Secondary neurological or systemic complication

  30 days after surgery

• Cumulative dexamethasone dosage

  30 days after surgery

• National Institutes of Health Stroke Scale (NIHSS) over time of the study period

  30 days after surgery

• Glasgow Coma Scale (GCS) over time of the study period and correlation with steroid medication

  30 days after surgery

• Volume of contrast enhancing tumor on preoperative MRI

  presurgery

Study Arms (1)

Treatment Dexamethasone

EXPERIMENTAL

The restrictive DEX regimen is applied from referral to the neurosurgical center until discharge. All administered steroids will be stopped immediately after study inclusion. If one or more of the previously defined failure criteria occurs, patients will be treated with DEX.

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

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

Treatment Dexamethasone

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Infratentorial lesions, brainstem lesions, multifocal lesions
• Need for treatment with steroids due to any other disease
• Contraindications to the administration of Dexamethasone
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (4)

Kantonsspital St. Gallen

Sankt Gallen, St.Gallen, 9007, Switzerland

NOT YET RECRUITING

Universitätsspital Basel

Basel, 4031, Switzerland

NOT YET RECRUITING

Department of Neurosurgery

Bern, 3010, Switzerland

RECRUITING

Universitätsspital Zürich

Zurich, 8091, Switzerland

NOT YET RECRUITING

Related Publications (11)

• GALICICH JH, FRENCH LA, MELBY JC. Use of dexamethasone in treatment of cerebral edema associated with brain tumors. J Lancet. 1961 Feb;81:46-53. No abstract available.

  PMID: 13703072 BACKGROUND

• KOFMAN S, GARVIN JS, NAGAMANI D, TAYLOR SG 3rd. Treatment of cerebral metastases from breast carcinoma with prednisolone. J Am Med Assoc. 1957 Apr 20;163(16):1473-6. doi: 10.1001/jama.1957.02970510039008. No abstract available.

  PMID: 13415910 BACKGROUND

• Luedi MM, Singh SK, Mosley JC, Hassan ISA, Hatami M, Gumin J, Andereggen L, Sulman EP, Lang FF, Stueber F, Fuller GN, Colen RR, Zinn PO. Dexamethasone-mediated oncogenicity in vitro and in an animal model of glioblastoma. J Neurosurg. 2018 Dec 1;129(6):1446-1455. doi: 10.3171/2017.7.JNS17668. Epub 2018 Jan 12.

  PMID: 29328002 BACKGROUND

• Ly KI, Wen PY. Clinical Relevance of Steroid Use in Neuro-Oncology. Curr Neurol Neurosci Rep. 2017 Jan;17(1):5. doi: 10.1007/s11910-017-0713-6.

  PMID: 28138871 BACKGROUND

• Pitter KL, Tamagno I, Alikhanyan K, Hosni-Ahmed A, Pattwell SS, Donnola S, Dai C, Ozawa T, Chang M, Chan TA, Beal K, Bishop AJ, Barker CA, Jones TS, Hentschel B, Gorlia T, Schlegel U, Stupp R, Weller M, Holland EC, Hambardzumyan D. Corticosteroids compromise survival in glioblastoma. Brain. 2016 May;139(Pt 5):1458-71. doi: 10.1093/brain/aww046. Epub 2016 Mar 28.

  PMID: 27020328 BACKGROUND

• Roth P, Wick W, Weller M. Steroids in neurooncology: actions, indications, side-effects. Curr Opin Neurol. 2010 Dec;23(6):597-602. doi: 10.1097/WCO.0b013e32833e5a5d.

  PMID: 20962642 BACKGROUND

• Shields LB, Shelton BJ, Shearer AJ, Chen L, Sun DA, Parsons S, Bourne TD, LaRocca R, Spalding AC. Dexamethasone administration during definitive radiation and temozolomide renders a poor prognosis in a retrospective analysis of newly diagnosed glioblastoma patients. Radiat Oncol. 2015 Oct 31;10:222. doi: 10.1186/s13014-015-0527-0.

  PMID: 26520780 BACKGROUND

• Ueda S, Mineta T, Nakahara Y, Okamoto H, Shiraishi T, Tabuchi K. Induction of the DNA repair gene O6-methylguanine-DNA methyltransferase by dexamethasone in glioblastomas. J Neurosurg. 2004 Oct;101(4):659-63. doi: 10.3171/jns.2004.101.4.0659.

  PMID: 15481722 BACKGROUND

• Wong ET, Lok E, Gautam S, Swanson KD. Dexamethasone exerts profound immunologic interference on treatment efficacy for recurrent glioblastoma. Br J Cancer. 2015 Dec 1;113(11):1642. doi: 10.1038/bjc.2015.404. No abstract available.

  PMID: 26625224 BACKGROUND

• Weinstein JD, Toy FJ, Jaffe ME, Goldberg HI. The effect of dexamethasone on brain edema in patients with metastatic brain tumors. Neurology. 1973 Feb;23(2):121-9. doi: 10.1212/wnl.23.2.121. No abstract available.

  PMID: 4734508 BACKGROUND

• Derr RL, Ye X, Islas MU, Desideri S, Saudek CD, Grossman SA. Association between hyperglycemia and survival in patients with newly diagnosed glioblastoma. J Clin Oncol. 2009 Mar 1;27(7):1082-6. doi: 10.1200/JCO.2008.19.1098. Epub 2009 Jan 12.

  PMID: 19139429 RESULT

MeSH Terms

Conditions

Glioblastoma

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Andreas Raabe, MD

  Inselspital Bern, Department of Neurosurgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johannes Goldberg, MD

CONTACT

+41316322409; johannes.goldberg@insel.ch

Nicole Söll, CDM

CONTACT

+41316323164; nicole.soell@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 12, 2020
• Study Start: May 8, 2020
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: July 9, 2025

Record last verified: 2025-07

Locations

CH (4)