GlioblastomaNCT06140875
Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With Radiochemotherapy and Maintenance Chemotherapy in Patients With Glioblastoma (Brain-RF)
A study testing Radiofrequency electromagnetic field treatment in people with Glioblastoma, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Combined chemoradiation and radiofrequency electromagnetic field treatment for patients with glioblastoma Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Radiofrequency electromagnetic field treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteGermany
- Study dates
- 15 Nov 2023to 14 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Charité Universitätsmedizin Berlin
Berlin, 13353
Yvonne Saewe, +49 30 450 527318, yvonne.saewe@charite.de
Pirus Ghadjar, Prof. Dr.
About this study
Combined chemoradiation and radiofrequency electromagnetic field treatment for patients with glioblastoma
Read the 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.
- Conditions
- Glioblastoma
- Being tested
- Radiofrequency electromagnetic field treatment
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency electromagnetic field treatmentDevice
Also called mEHT, capacitive hyperthermia, electrohyperthermia
Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz
| Study group | Role | What they receive |
|---|---|---|
| Experimental | 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. Receives: Device: Radiofrequency electromagnetic field treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS at 6 months
Progression-free survival
Measured: 6 months after surgery or biopsy
Secondary outcomes (8)
OS
Overall Survival
Measured: Through study completion, an average of 15 months
Acute and late toxicity
CTCAE version 5
Measured: During 5,5 years of trial conduction
Subsequent salvage treatment of the brain
Need for brain surgery, new drug therapy or additional radiotherapy of the brain
Measured: During 5,5 years of trial conduction
PFS
Progression-free survival
Measured: During 5,5 years of trial conduction
QOL
European Organisation for Research and Treatment of Cancer (EORTC) QLQ-BN20
Measured: During 5,5 years of trial conduction
Mini mental state examination
Brain function testing
Measured: During 5,5 years of trial conduction
QOL
European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30
Measured: During 5,5 years of trial conduction
Depression and anxiety testing
Hospital Anxiety and Depression Scale (HADS-D)
Measured: During 5,5 years of trial conduction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2023
- Study start15 Nov 2023
- Primary completion14 May 2029 (estimated)
- Study completion14 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pirus Ghadjar, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140875
- Sponsor's protocol ID
- Brain-RF
- Status last verified
- Feb 2025
- First submitted
- 15 Nov 2023
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With Radiochemotherapy and Maintenance Chemotherapy in Patients With Glioblastoma (Brain-RF)
- ClinicalTrials.gov ID
- NCT06140875
- Acronym / sponsor ID
- Brain-RF
- Conditions
- Glioblastoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 14 May 2029 (estimated)
- Study completion
- 14 May 2029 (estimated)
- First posted
- 20 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Radiofrequency electromagnetic field treatmentRadiochemotherapy (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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency electromagnetic field treatmentAlso: mEHT, capacitive hyperthermia, electrohyperthermiaRadiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz | Device | Experimental |
Primary outcome
PFS at 6 months
Time frame: 6 months after surgery or biopsy
Progression-free survival
8 secondary outcomes
OS
Time frame: Through study completion, an average of 15 months
Acute and late toxicity
Time frame: During 5,5 years of trial conduction
Subsequent salvage treatment of the brain
Time frame: During 5,5 years of trial conduction
PFS
Time frame: During 5,5 years of trial conduction
QOL
Time frame: During 5,5 years of trial conduction
Mini mental state examination
Time frame: During 5,5 years of trial conduction
QOL
Time frame: During 5,5 years of trial conduction
Depression and anxiety testing
Time frame: During 5,5 years of trial conduction
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency electromagnetic field treatment in people with Glioblastoma, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pirus Ghadjar, Prof. Dr. (+49 30 450 527318, pirus.ghadjar@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS at 6 months (time frame: 6 months after surgery or biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.