Proton Therapy Research Infrastructure- ProTRAIT- Neuro-oncology
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
- 否
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)
