Treatment for glioblastoma using radiofrequency electromagnetic fields and chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Charité Universitätsmedizin Berlin
  Berlin, Germany Recruiting

Study contacts

• Study coordinator: Pirus Ghadjar, Prof. Dr.
• Email: pirus.ghadjar@charite.de
• Phone: +49 30 450 527318

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.