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

Inclusion Criteria:

• Pathological evidence of newly diagnosed glioblastoma according to WHOclassification 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 theCeTeG/NOA-09 protocol (+ Lomustin)

• Patient must be planned for concomitant RCT with a total RT dose of 60 Gy over sixweeks 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 cancerwithin the past 5 years

• History of cancers or other comorbidities that limit life expectancy to less thanfive years

• Postoperative evidence of increased intracranial pressure (midline shift > 5mm,clinically significant papilledema, vomiting and nausea or reduced level ofconsciousness)

• Technical impossibility to use magnetic resonance imaging (MRI) or known allergiesagainst MRI and/or computed tomography (CT) contrast agents

• Technical impossibility to use AM-RF-EMF (pacemaker, defibrillator or deep brainstimulator, metal implants)

• Participants of childbearing age unwilling to use or not capable of using effectivecontraception

• Pregnant patients