Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With Radiochemotherapy and Maintenance Chemotherapy in Patients With Glioblastoma (Brain-RF)
Recruiting now · Not applicable
Conditions studied: Glioblastoma
In brief
Combined chemoradiation and radiofrequency electromagnetic field treatment for patients with glioblastoma
Key facts
- Study ID
- NCT06140875
- Run by
- Charite University, Berlin, Germany
- People needed
- 26
- Starts
- 2023-11-15
- Expected to finish
- 2029-05-14
- Last updated by the study team
- 2025-02-13
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Charité Universitätsmedizin Berlin — Berlin, Germany (enrolling)
Full record on ClinicalTrials.gov
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