HUmanitas PROtontherapy (HU-PRO)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- collecting real world data
研究概览
简要总结
Proton therapy is a cancer treatment, similar to the more commonly used radiation therapy. It uses radiation to destroy cancer cells and helps control the disease in the treated area.
However, when proton therapy is compared with standard radiation therapy, many studies show fewer side effects and better disease control. This is due to the unique physical properties of the particles used in proton therapy.
At present, in Italy, this innovative treatment is available only for selected diseases, as defined by national guidelines. For this reason, it is very important to collect as much data as possible to support the further development of proton therapy and to improve treatment safety and effectiveness.
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
- •Solid tumors candidate to proton therapy, in particular, according to Italian regolamentations
- •Written informed consent for HU-PRO according to applicable legal and ethical requirements
- •Indication for proton therapy
- •≥ 18 years old
- •ECOG PS (performance status scale) 0-2
排除标准
- •Age < 18 years old
- •ECOG (performance status scale) >3
- •Life expectancy < 3 months
- •Inability to provide informed consent
研究组 & 干预措施
proton therapy
all patients treated with proton therapy according to clinical practice
结局指标
主要结局
collecting real world data
时间窗: from enrollment to 10 years
To collect real-world data on cancer patients treated with protonherapy, to support research and to provide evidence of the role of protontherapy in a multidisciplinary approach.
次要结局
- identify prognostic biomarkers(from enrollment to 10 years)
- toxicities profiles(from enrollment to 10 years)
- Secondary Cancer Risk(from enrollment to 10 years)
- Optimize treatment plannig(from enrollment to 10 years)
- Asses Outcomes in Rare or Radioresistant Tumors(from enrollment to 10 years)
- Analyze Quality of Life Outcomes(from enrollment to 10 years)
- Monitor Treatment Adherence and Compliance(from enrollment to 10 years)