JOURNAL ONKOLOGIE – STUDIE

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

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT06140875

Studienbeginn:
November 2023

Letztes Update:
20.11.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Glioblastoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Charite University, Berlin, Germany

Collaborator:
-

Kontakt

Pirus Ghadjar, Prof. Dr.
Kontakt:
Phone: +49 30 450 527318
E-Mail: pirus.ghadjar@charite.de» Kontaktdaten anzeigen

David Kaul, PD. Dr.
Kontakt:
Phone: +49 30 450 527318
E-Mail: david.kaul@charite.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Charité Universitätsmedizin Berlin
13353 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Yvonne Saewe
Phone: +49 30 450 527318
E-Mail: yvonne.saewe@charite.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. PFS at 6 months (Time Frame - 6 months after surgery or biopsy):
Progression-free survival

Secondary outcome:

1. OS (Time Frame - Through study completion, an average of 15 months):
Overall Survival

2. Acute and late toxicity (Time Frame - During 5,5 years of trial conduction):
CTCAE version 5

3. Subsequent salvage treatment of the brain (Time Frame - During 5,5 years of trial conduction):
Need for brain surgery, new drug therapy or additional radiotherapy of the brain

4. PFS (Time Frame - During 5,5 years of trial conduction):
Progression-free survival

5. QOL (Time Frame - During 5,5 years of trial conduction):
European Organisation for Research and Treatment of Cancer (EORTC) QLQ-BN20

6. Mini mental state examination (Time Frame - During 5,5 years of trial conduction):
Brain function testing

7. QOL (Time Frame - During 5,5 years of trial conduction):
European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30

8. Depression and anxiety testing (Time Frame - During 5,5 years of trial conduction):
Hospital Anxiety and Depression Scale (HADS-D)

Geprüfte Regime

Radiofrequency electromagnetic field treatment (mEHT / capacitive hyperthermia / electrohyperthermia / ):
Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz

Quelle: ClinicalTrials.gov

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