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

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Recruiting

CT.gov ID

NCT06140875

Collaborator

(none)

Enrollment

Location

Arm

65.9

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Combined chemoradiation and radiofrequency electromagnetic field treatment for patients with glioblastoma

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma	Device: Radiofrequency electromagnetic field treatment	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

26 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 15, 2023

Anticipated Primary Completion Date :

May 14, 2029

Anticipated Study Completion Date :

May 14, 2029

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

PFS at 6 months [6 months after surgery or biopsy]
Progression-free survival

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charité Universitätsmedizin Berlin	Berlin		Germany	13353

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pirus Ghadjar, Prof. Dr., Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT06140875

Other Study ID Numbers:

Brain-RF

First Posted:

Nov 20, 2023

Last Update Posted:

Nov 20, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Glioblastoma

Study Results

No Results Posted as of Nov 20, 2023