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临床试验/NCT04648462
NCT04648462招募中不适用

Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology

Maastricht Radiation Oncology3 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,500
试验地点
3
主要终点
Neurocognitive failure at 5 years

研究概览

简要总结

The first proton therapy treatments in the Netherlands have taken place in 2018. Due to the physical properties of protons, proton therapy has tremendous potential to reduce the radiation dose to the healthy, tumour-surrounding tissues. In turn, this leads to less radiation-induced complications, and a decrease in the formation of secondary tumours. The Netherlands has spearheaded the development of the model-based approach (MBA) for the selection of patients for proton therapy when applied to prevent radiation-induced complications. In MBA, a pre-treatment in-silico planning study is done, comparing proton and photon treatment plans in each individual patient, to determine (1) whether there is a significant difference in dose in the relevant organs at risk (ΔDose), and (2) whether this dose difference translates into an expected clinical benefit in terms of NormalTissue Complication Probabilities (ΔNTCP). To translate ΔDose into ΔNTCP, NTCP-models are used, which are prediction models describing the relation between dose parameters and the likelihood of radiation-induced complications. The Dutch Society for Radiotherapy and Oncology (NVRO) setup the selection criteria for proton therapy in 2015, taking into account toxicity and NTCP. However, NTCP-models can be affected by changes in the irradiation technique. Therefore, it is paramount to continuously update and validate these NTCP-models in subsequent patient cohorts treated with new techniques. In ProTRAIT, a Findable, Accessible, Interoperable and Reusable (FAIR)data infrastructure for both clinical and 3D image and 3D dose information has been developed and deployed for proton therapy in the Netherlands. It allows for a prospective, standardized, multi-centric data from all Dutch proton and a representative group of photon therapy patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • All brain tumors with a favorable prognosis (median survival > 10 year)
  • Age ≥ 18 years
  • ECOG performance status 0 - 1 / Karnofsky performance status 80 - 100
  • No - minimal neurocognitive impairment
  • Dosimetrical gain of protontherapy relative to photontherapy (≥5% on supratentorial brain dose or hippocampi)
  • Informed consent

排除标准

  • Not eligible for chemotherapy
  • Eligible for stereotactic radiotherapy

结局指标

主要结局

Neurocognitive failure at 5 years

时间窗: 5 years after radiotherapy

Time to neurocognitive failure, defined as the time from last radiotherapeutic treatment to the first instance of a measured HVLT-dr of -1.5Z based on the normal data

次要结局

  • HVLT- delayed recall decline at 5 years(5 years after radiotherapy)
  • HVLT total recall decline at 5 years(5 years after radiotherapy)
  • TMT a decline at 5 years(5 years after radiotherapy)
  • TMT b decline at 5 years(5 years after radiotherapy)
  • COWA total decline at 5 years(5 years after radiotherapy)

研究者

发起方
Maastricht Radiation Oncology
申办方类型
Other
责任方
Sponsor

研究点 (3)

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