Treatment for glioblastoma using radiofrequency electromagnetic fields and chemotherapy

Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined With Radiochemotherapy and Maintenance Chemotherapy in Patients With Glioblastoma (Brain-RF)

This study is testing whether combining radiofrequency electromagnetic field treatment with standard chemotherapy can help people with newly diagnosed glioblastoma feel better and improve their outcomes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 26 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Charite University, Berlin, Germany (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Berlin)
• Trial ID: NCT06140875 on ClinicalTrials.gov

What this trial studies

This study investigates the combined effects of radiofrequency electromagnetic field treatment alongside standard chemoradiotherapy in patients with newly diagnosed glioblastoma. Conducted at Charité Universitätsmedizin Berlin, the trial aims to assess the feasibility of this innovative approach, leveraging existing retrospective data that suggests potential effectiveness and low toxicity. Participants will receive a total radiation dose of 60 Gy over six weeks, followed by maintenance chemotherapy with temozolomide. The study will compare outcomes with data from a similar patient population to evaluate the treatment's efficacy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with newly diagnosed glioblastoma who have undergone tumor resection and meet specific health criteria.

Not a fit: Patients with a history of cranial radiation or recent cancer treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new, effective option for patients with glioblastoma, potentially improving survival rates and quality of life.

How similar studies have performed: While there is limited prospective data on this combined approach, retrospective studies suggest potential effectiveness, indicating a novel exploration in glioblastoma treatment.

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

Where this trial is running

Berlin

• Charité Universitätsmedizin Berlin — Berlin, Germany (Recruiting)

Study contacts

• Study coordinator: Pirus Ghadjar, Prof. Dr.

Conditions Glioblastoma