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

Обзор

Combined chemoradiation and radiofrequency electromagnetic field treatment for patients with glioblastoma

Подробное описание

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.

Вмешательства

• Устройство Radiofrequency electromagnetic field treatment
  Radiofrequency electromagnetic field treatment using a carrier frequency of 13.56 MHz

Первичные конечные точки

• PFS at 6 months [Срок оценки: 6 months after surgery or biopsy]

Вторичные конечные точки (8)

• OS [Срок оценки: Through study completion, an average of 15 months]
• Acute and late toxicity [Срок оценки: During 5,5 years of trial conduction]
• Subsequent salvage treatment of the brain [Срок оценки: During 5,5 years of trial conduction]
• PFS [Срок оценки: During 5,5 years of trial conduction]
• QOL [Срок оценки: During 5,5 years of trial conduction]
• Mini mental state examination [Срок оценки: During 5,5 years of trial conduction]
• QOL [Срок оценки: During 5,5 years of trial conduction]
• Depression and anxiety testing [Срок оценки: During 5,5 years of trial conduction]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• Charité Universitätsmedizin Berlin — Berlin

Идентификаторы

NCT: NCT06140875 · Brain-RF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗