Glioblastoma Radiotherapy Using IMRT or Proton Beams
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 326
- 试验地点
- 3
- 主要终点
- Cumulative rate of toxicity
研究概览
简要总结
Radiation therapy is an integral part of the multimodal primary therapy of glioblastomas. As the overall prognosis in this tumor entity remains unfavorable, current research is focused on additional drug therapies, which are often accompanied by increases in toxicity. By using proton beams instead of photon beams, it is possible to protect large parts of the brain which are not affected by the tumor more effectively. An initial retrospective matched-pair analysis showed that this theoretical physical benefit is also clinically associated with a reduction in toxicity during therapy and in the first few months thereafter. The aim of the GRIPS study is to prospectively test this clinical benefit in a randomized, open-label Phase III study. Patients are treated in the study using either modern photon radiation techniques (standard arm) or proton beams (experimental arm). The primary endpoint is the cumulative toxicity CTC grade 2 and higher in the first 4 months. Secondary endpoints include overall survival, progression-free survival, quality of life, and neurocognition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •histologically confirmed gliomblastoma WHO IV (operated or after biopsy)
- •Indication for radiotherapy / radiochemotherapy
- •Informed consent
- •KI ≥ 60% or ECOG 0/1
- •Age ≥ 18 years
- •Sufficient effective contraception
排除标准
- •Patient is not able to consent
- •Previous radiotherapy in the brain or skull base
- •Active medical implants for which there is no ion radiation authorization at the time of treatment (e.g., cardiac pacemaker, defibrillator, ...)
- •Contraindication to MRI imaging
- •Simultaneous participation in another clinical trial that could influence the outcome of this study or other study
研究组 & 干预措施
Arm B: Photon IMRT
Photon irradiation applied as intensity-modulated radiotherapy
干预措施: Photon irradiation (Radiation)
Arm A: Proton irradiation
Irradiation applied with protons
干预措施: Proton irradiation (Radiation)
结局指标
主要结局
Cumulative rate of toxicity
时间窗: from start of radiotherapy until progress (max. month 4)
Cumulative rate of toxicity ≥ grade 2 (until progress (max. month 4))
次要结局
- Overall survival(1 year and 2 years)
- Late Toxicity(6 weeks after end of therapy (end of therapy up to month 4))
- Quality of life according to EORTC QLQ-C30(1 year and 2 years)
- Measuring number of Lymphocytes count(end of therapy up to month 4)
- Progression free survival(1 year and 2 years)
- Acute Toxicity(start of therapy until 6 weeks after end of therapy (end of therapy up to month 4))
- Quality of life according to EORTC QLQ-BN20(1 year and 2 years)
- Neurocognition(1 year and 2 years)
研究者
Juergen Debus
Prof. Dr. Dr. Jürgen Debus
University Hospital Heidelberg
