Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With Radiochemotherapy and Maintenance Chemotherapy in Patients With Glioblastoma (Brain-RF)
NCT ID: NCT06140875
Last Updated: 2025-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
26 participants
INTERVENTIONAL
2023-11-15
2029-05-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental
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.
Radiofrequency electromagnetic field treatment
Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz
Interventions
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Radiofrequency electromagnetic field treatment
Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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Pirus Ghadjar
Prof. Dr.
Locations
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Charité Universitätsmedizin Berlin
Berlin, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Brain-RF
Identifier Type: -
Identifier Source: org_study_id
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