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临床试验/NCT04752280
NCT04752280招募中不适用

Glioblastoma Radiotherapy Using IMRT or Proton Beams

University Hospital Heidelberg3 个研究点 分布在 1 个国家目标入组 326 人开始时间: 2021年4月19日最近更新:
适应症
干预措施

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

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

Active Comparator

Photon irradiation applied as intensity-modulated radiotherapy

干预措施: Photon irradiation (Radiation)

Arm A: Proton irradiation

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Juergen Debus

Prof. Dr. Dr. Jürgen Debus

University Hospital Heidelberg

研究点 (3)

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