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

Study Overview
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Brief Summary
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Combined chemoradiation and radiofrequency electromagnetic field treatment for patients with glioblastoma

Detailed Description
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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.

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

Conditions
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Glioblastoma

Intervention / Treatment
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* Device: Radiofrequency electromagnetic field treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>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<br>* Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz<br>* Other names: electrohyperthermia;|

What is the study measuring?
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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 |