跳至主要内容
临床试验/NCT01795300
NCT01795300撤回不适用

Randomized Comparison of Proton and Carbon Ion Radiotherapy With Advanced Photon Radiotherapy in Skull Base Meningiomas: The PINOCCHIO Trial.

University Hospital Heidelberg2 个研究点 分布在 1 个国家开始时间: 2020年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Toxicity graded according to CTCAE Version 4.1 after 1 year

研究概览

简要总结

In PINOCCHIO-Triayl, carbon ion radiotherapy is compared to proton and advanced photon radiotherapy in patients with skull base meningiomas. There will be two treatment arms with photons, one arm with hypofractionated photon radiotherapy, and one arm with conventional fractionation. The study is designed as descriptive study on feasibility of the investigated therapies aiming at a comparison of toxicities. The study will serve as a basis for further larger randomized protocols comparing efficacy of the therapies, assuming toxicity is comparable in all four treatment arms. Primary endpoint is toxicity, secondary endpoints are overall survival, progression-free survival and quality of life.

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Toxicity graded according to CTCAE Version 4.1 after 1 year

时间窗: 1 year

Toxicity graded according to CTCAE Version 4.1 after 1 year

次要结局

  • Progression-free survival(3 years)
  • Overall survival(3 years)
  • Quality of Life(3 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 (2)

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