RecruitingNot ApplicableNCT06140875
Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With Radiochemotherapy and Maintenance Chemotherapy in Patients With Glioblastoma (Brain-RF)
Sponsor
Charite University, Berlin, Germany
Enrollment
26 participants
Start Date
Nov 15, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
Combined chemoradiation and radiofrequency electromagnetic field treatment for patients with glioblastoma
Eligibility
Min Age: 18 YearsMax Age: 70 Years
Inclusion Criteria7
- 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 Criteria8
- 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
Interventions
DEVICERadiofrequency electromagnetic field treatment
Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz
Locations(1)
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NCT06140875
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