Clinical trial · Interventional
Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With Radiochemotherapy and Maintenance Chemotherapy in Patients With Glioblastoma (Brain-RF)
NCT06140875CI-TRIAL-00085915recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Combined chemoradiation and radiofrequency electromagnetic field treatment for patients with glioblastoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiofrequency electromagnetic field treatment | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental
- 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.
- interventionNames
- Device: Radiofrequency electromagnetic field treatment
Primary outcomes (1)
- measure
- PFS at 6 months
- timeFrame
- 6 months after surgery or biopsy
- description
- Progression-free survival
Secondary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.