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

RecruitingNAAges 18 Years - 70 YearsAllCharite University, Berlin, Germany
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In plain words

What the trial is, and whether it could suit you

Combined chemoradiation and radiofrequency electromagnetic field treatment for patients with glioblastoma

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Radiofrequency electromagnetic field treatment
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Where

1 site
Charité Universitätsmedizin Berlin
Berlin, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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