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

Glioblastoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06140875
• Other study ID #: Brain-RF
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: May 14, 2029

Study information

• Verified date: November 2023
• Source: Charite University, Berlin, Germany
• Contact: Pirus Ghadjar, Prof. Dr.
• Phone: +49 30 450 527318
• Email: pirus.ghadjar[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Combined chemoradiation and radiofrequency electromagnetic field treatment for patients with glioblastoma

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: May 14, 2029
• Est. primary completion date: May 14, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Device:
• Radiofrequency electromagnetic field treatment
Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS at 6 months	Progression-free survival	6 months after surgery or biopsy
Secondary	OS	Overall Survival	Through study completion, an average of 15 months
Secondary	Acute and late toxicity	CTCAE version 5	During 5,5 years of trial conduction
Secondary	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
Secondary	PFS	Progression-free survival	During 5,5 years of trial conduction
Secondary	QOL	European Organisation for Research and Treatment of Cancer (EORTC) QLQ-BN20	During 5,5 years of trial conduction
Secondary	Mini mental state examination	Brain function testing	During 5,5 years of trial conduction
Secondary	QOL	European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30	During 5,5 years of trial conduction
Secondary	Depression and anxiety testing	Hospital Anxiety and Depression Scale (HADS-D)	During 5,5 years of trial conduction