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

Summary

Combined chemoradiation and radiofrequency electromagnetic field treatment for patients with glioblastoma

Interventions

• Radiofrequency electromagnetic field treatment · DEVICE

  Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (1)

• Charité Universitätsmedizin Berlin, Berlin, Germany · RECRUITING