Image Guided Reirradiation of High-grade Glioma - a Phase I/II Dose Escalation Study
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 4
- 主要终点
- Toxicity
研究概览
简要总结
The purpose of the study is to evaluate the short- and long term toxicity of radiotherapy to patients with recurrent high-grade glioma who have previously received radiotherapy and to determine the best dose and treatment regimen. Positron emission tomography (PET) using an amino acid tracer, 18-fluoro-ethyltyrosine (18F-FET), is used for target delineation.The study examines, in four sequential treatment groups, the effect of dose, hypofractionation and treatment volume on toxicity. Upon completion of the phase I part, the study progresses to phase II where the best dose- and treatment regimen will be chosen for treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •recurrent high-grade glioma
- •previous focal radiotherapy for high-grade glioma
- •no standard treatment options available/indicated
- •ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1 or 2
- •life expectancy > 3 months
- •hemoglobin value > 6 mmol/l (transfusion permitted)
- •able to understand oral and written Danish
排除标准
- •disseminated recurrent disease
- •infection or wound dehiscence or other pathological condition in meninges/skull/scalp
- •symptoms of elevated intracranial pressure
- •very early recurrence following primary radiotherapy (< or equal to 3 months)
- •contraindications to magnetic resonance imaging (MRI) or positron emission tomography (PET)
- •other previous radiotherapy to the brain than primary course of irradiation
结局指标
主要结局
Toxicity
时间窗: One year
Early (\<4 weeks) and late (\> 4 weeks) toxicity evaluated by Common Toxicity Criteria ver. 3.0 at multiple time points up to one year after treatment. (for phase I part of the study)
Time to neurocognitive decline
时间窗: Up to one year
Time to neurocognitive decline assessed using a test battery comprised of validated tests at multiple time points. (for phase II part of the study)
Diagnostic precision of 18F-FET-PET imaging in recurrent high-grade glioma
时间窗: Approximately one to two weeks prior to radiotherapy
Diagnostic accuracy (positive- and negative predictive value) of 18F-FET-PET guided biopsies (optional procedure) in patients who will receive reirradiation for recurrent high-grade glioma in the study. (for phase I part of the study).
Time to progression
时间窗: Up to one year
Time to disease progression evaluated by RANO (Response Assessment in Neuro-Oncology) criteria (for phase II part of the study).
次要结局
- Objective response rate(Up to one year)
- Value of 18F-FET-PET in reirradiation of high-grade glioma(One year)
研究者
Søren Møller
MD
Rigshospitalet, Denmark