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

NCT06140875 | Recruiting

• 1 other identifier: Brain-RF
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Combined chemoradiation and radiofrequency electromagnetic field treatment for patients with glioblastoma

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• PFS at 6 months

  Progression-free survival

  6 months after surgery or biopsy

Secondary Outcomes (8)

• OS

  Through study completion, an average of 15 months

• Acute and late toxicity

  During 5,5 years of trial conduction

• Subsequent salvage treatment of the brain

  During 5,5 years of trial conduction

• PFS

  During 5,5 years of trial conduction

• QOL

  During 5,5 years of trial conduction

Study Arms (1)

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

Interventions

Radiofrequency electromagnetic field treatment DEVICE

Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz

Also known as: mEHT, capacitive hyperthermia, electrohyperthermia

Experimental

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité Universitätsmedizin Berlin

Berlin, 13353, Germany

RECRUITING

MeSH Terms

Conditions

Glioblastoma

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

Central Study Contacts

Pirus Ghadjar, Prof. Dr.

CONTACT

+49 30 450 527318; pirus.ghadjar@charite.de

David Kaul, PD. Dr.

CONTACT

+49 30 450 527318; david.kaul@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 20, 2023
• Study Start: November 15, 2023
• Primary Completion (Estimated): May 14, 2029
• Study Completion (Estimated): May 14, 2029
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

DE (1)