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

Charité University Medicine Berlin

Status: Enrolling

Conditions: Glioblastoma

Treatments: Device: Radiofrequency electromagnetic field treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06140875

Brain-RF

Details and patient eligibility

About

Combined chemoradiation and radiofrequency electromagnetic field treatment for patients with glioblastoma

Full description

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.

Enrollment: 26 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Experimental

Experimental group

Description:

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.

Treatment:

Device: Radiofrequency electromagnetic field treatment