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

Overview

Combined chemoradiation and radiofrequency electromagnetic field treatment for patients with glioblastoma

Detailed 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.

Interventions

• Device Radiofrequency electromagnetic field treatment
  Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz

Primary outcome measures

• PFS at 6 months [Time frame: 6 months after surgery or biopsy]

Secondary outcome measures (8)

• OS [Time frame: Through study completion, an average of 15 months]
• Acute and late toxicity [Time frame: During 5,5 years of trial conduction]
• Subsequent salvage treatment of the brain [Time frame: During 5,5 years of trial conduction]
• PFS [Time frame: During 5,5 years of trial conduction]
• QOL [Time frame: During 5,5 years of trial conduction]
• Mini mental state examination [Time frame: During 5,5 years of trial conduction]
• QOL [Time frame: During 5,5 years of trial conduction]
• Depression and anxiety testing [Time frame: During 5,5 years of trial conduction]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Germany · 1 center

• Charité Universitätsmedizin Berlin — Berlin

Identifiers

NCT: NCT06140875 · Brain-RF

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗