Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined with Radiochemotherapy and Maintenance Chemotherapy in Patients with Glioblastoma (Brain-RF)

Combined chemoradiation and radiofrequency electromagnetic field treatment for patients with glioblastoma

Study Overview

• Status: Recruiting
• Conditions: Glioblastoma
• Intervention / Treatment: Device: Radiofrequency electromagnetic field treatment

Detailed Description

Charité Universitätsmedizin Berlin is currently the only German University Hospital with an available capacitive radiofrequency electromagnetic field treatment device. While there is retrospective data available regarding the assumed effectiveness and low toxicity profile of radiofrequency electromagnetic field treatment for glioblastoma in the palliative setting, there is only few prospective data available on the combined effect first-line chemoradiation and radiofrequency electromagnetic field treatment. The investigators aim to conduct a feasibility trial and plan to compare the results with data of a prospective trial with a comparable patient population.

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pirus Ghadjar, Prof. Dr.; Phone Number: +49 30 450 527318; Email: pirus.ghadjar@charite.de
• Study Contact Backup: Name: David Kaul, PD. Dr.; Phone Number: +49 30 450 527318; Email: david.kaul@charite.de

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Charité Universitätsmedizin Berlin
    • Contact: Yvonne Saewe; Phone Number: +49 30 450 527318; Email: yvonne.saewe@charite.de
    • Contact: Pirus Ghadjar, Prof. Dr.
    • Contact: David Kaul, PD Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pathological evidence of newly diagnosed glioblastoma according to WHO classification criteria
• Patients 18 to 70 years of age with a WHO performance status of 2 or less
• All patients must sign written informed consent
• Adequate hematologic, renal, and hepatic function (absolute neutrophil count, ≥1,5 x 103/μL; platelet count, ≥100 x 103/μL; serum creatinine ≤1.7 mg/dL; total bilirubin > upper limit of normal; AST or ALT ≤3 times the upper limit of normal)
• Patient must have received subtotal or gross total resection of the tumor
• MGMT-promotor methylated patients must have refused therapy according to the CeTeG/NOA-09 protocol (+ Lomustin)
• Patient must be planned for concomitant RCT with a total RT dose of 60 Gy over six weeks and temozolomide followed by six cycles of maintenance CT using temozolomide

Exclusion Criteria:

• Previous cranial RT
• Cytostatic therapy / anti-angiogenic substances / CT or radiation therapy for cancer within the past 5 years
• History of cancers or other comorbidities that limit life expectancy to less than five years
• Postoperative evidence of increased intracranial pressure (midline shift > 5mm, clinically significant papilledema, vomiting and nausea or reduced level of consciousness)
• Technical impossibility to use magnetic resonance imaging (MRI) or known allergies against MRI and/or computed tomography (CT) contrast agents
• Technical impossibility to use AM-RF-EMF (pacemaker, defibrillator or deep brain stimulator, metal implants)
• Participants of childbearing age unwilling to use or not capable of using effective contraception
• Pregnant patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental; Radiochemotherapy (RCT) and maintenance chemotherapy (CT) according to Stupp et al. 2005 combined with radiofrequency electromagnetic field treatment. The standard therapy involves gross- or subtotal tumor resection if feasible (alternatively biopsy only) followed by RCT (60 Gy over six weeks) with concomitant CT (temozolomide 75mg/m2) on all days, followed by maintenance CT (temozolomide150-200 mg/m2) on d1-5 for six cycles every 28 days. The trial intervention includes radiofrequency electromagnetic field treatment for 60 minutes three times a week during RCT and twice a week during d1-5 of maintenance CT, resulting in a total number of 30 radiofrequency electromagnetic field treatment therapy sessions.

Device: Radiofrequency electromagnetic field treatment; Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz; Other Names: mEHT; capacitive hyperthermia; electrohyperthermia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS at 6 months	Progression-free survival	6 months after surgery or biopsy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	Overall Survival	Through study completion, an average of 15 months
Acute and late toxicity	CTCAE version 5	During 5,5 years of trial conduction
Subsequent salvage treatment of the brain	Need for brain surgery, new drug therapy or additional radiotherapy of the brain	During 5,5 years of trial conduction
PFS	Progression-free survival	During 5,5 years of trial conduction
QOL	European Organisation for Research and Treatment of Cancer (EORTC) QLQ-BN20	During 5,5 years of trial conduction
Mini mental state examination	Brain function testing	During 5,5 years of trial conduction
QOL	European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30	During 5,5 years of trial conduction
Depression and anxiety testing	Hospital Anxiety and Depression Scale (HADS-D)	During 5,5 years of trial conduction

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): May 14, 2029
• Study Completion (Estimated): May 14, 2029

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 20, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: Brain-RF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No