A Prospective Registry Study to Record Clinical Results and Side Effects of Ion Beam Therapy at MedAustron
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,800
- 试验地点
- 1
- 主要终点
- Therapy response
研究概览
简要总结
The purpose of the study is the prospective and standardized data collection of patients treated with ion therapy at MedAustron.
详细描述
During and up to 10 years after radiation therapy data regarding tumor control and treatment response as well as acute and late toxicities will be collected at regular time intervals. Additionally quality of life and sociodemographic status will be assessed in all study patients and neurocognitive assessment will be performed in patients undergoing ion radiation of the brain.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with tumor disease treated with ion beam therapy at MedAustron
- •Signed informed consent form
排除标准
- •Comorbidities endangering treatment delivery or study compliance
结局指标
主要结局
Therapy response
时间窗: 10 years
Therapy Response according to RECIST Version 1.1
Overall survival
时间窗: 10 years
Local progression-free survival
时间窗: 10 years
Toxicity according to NCI CTCAE
时间窗: 10 years
Acute/late toxicity according to CTCAEv4.03, June 14,2010
Progression-free survival
时间窗: 10 years
Cause-specific survival
时间窗: 10 years
次要结局
- EORTC-QLQ-PR25(Through study completion, at 3, 5, and 10 years)
- EORTC-QLQ-BN20(Through study completion, at 3, 5, and 10 years)
- EORTC-QLQ-C30(Through study completion, at 3, 5, and 10 years)
- Neurocognitive test battery(Through study completion, at 3, 5, and 10 years)