Glioblastoma
Conditions
Brief summary
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
Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS at 6 months | 6 months after surgery or biopsy | Progression-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute and late toxicity | During 5,5 years of trial conduction | CTCAE version 5 |
| Subsequent salvage treatment of the brain | During 5,5 years of trial conduction | Need for brain surgery, new drug therapy or additional radiotherapy of the brain |
| PFS | During 5,5 years of trial conduction | Progression-free survival |
| OS | Through study completion, an average of 15 months | Overall Survival |
| Mini mental state examination | During 5,5 years of trial conduction | Brain function testing |
| Depression and anxiety testing | During 5,5 years of trial conduction | Hospital Anxiety and Depression Scale (HADS-D) |
| QOL | During 5,5 years of trial conduction | European Organisation for Research and Treatment of Cancer (EORTC) QLQ-BN20 |
Countries
Germany
Contacts
Primary ContactPirus Ghadjar, Prof. Dr.
Backup ContactDavid Kaul, PD. Dr.
Outcome results
None listed