NCT06140875招募中不适用
Amplitude Modulated Radiofrequency Electromagnetic Field Treatment Combined with Radiochemotherapy and Maintenance Chemotherapy in Patients with Glioblastoma (Brain-RF)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- PFS at 6 months
研究概览
简要总结
Combined chemoradiation and radiofrequency electromagnetic field treatment for patients with glioblastoma
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
PFS at 6 months
时间窗: 6 months after surgery or biopsy
Progression-free survival
次要结局
- OS(Through study completion, an average of 15 months)
- Acute and late toxicity(During 5,5 years of trial conduction)
- Subsequent salvage treatment of the brain(During 5,5 years of trial conduction)
- PFS(During 5,5 years of trial conduction)
- Mini mental state examination(During 5,5 years of trial conduction)
- Depression and anxiety testing(During 5,5 years of trial conduction)
- QOL(During 5,5 years of trial conduction)
研究者
Pirus Ghadjar
Prof. Dr.
Charite University, Berlin, Germany
研究点 (2)
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