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Trial Title:
Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With Radiochemotherapy and Maintenance Chemotherapy in Patients With Glioblastoma (Brain-RF)
NCT ID:
NCT06140875
Condition:
Glioblastoma
Conditions: Official terms:
Glioblastoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Radiofrequency electromagnetic field treatment
Description:
Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz
Arm group label:
Experimental
Other name:
mEHT
Other name:
capacitive hyperthermia
Other name:
electrohyperthermia
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Charité Universitätsmedizin Berlin
Address:
City:
Berlin
Zip:
13353
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Yvonne Saewe
Phone:
+49 30 450 527318
Email:
yvonne.saewe@charite.de
Investigator:
Last name:
Pirus Ghadjar, Prof. Dr.
Email:
Principal Investigator
Investigator:
Last name:
David Kaul, PD Dr.
Email:
Principal Investigator
Start date:
November 15, 2023
Completion date:
May 14, 2029
Lead sponsor:
Agency:
Charite University, Berlin, Germany
Agency class:
Other
Source:
Charite University, Berlin, Germany
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06140875
