Hypofractionated Ion Irradiation (Protons or Carbon Ions) of Sacrococcygeal Chordoma
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- safety and feasibility of hypofractionated irradiation in patients with sacrococcygeal chordoma using ions (protons or carbon ions) in raster scan technique
研究概览
简要总结
The purpose of this study is to evaluate the safety and feasibility of primary hypofractionated irradiation of sacrococcygeal chordoma with carbon ions or protons using the raster scan technique.
详细描述
The primary objective of this trial is safety and feasibility of hypofractionated irradiation in patients with sacrococcygeal chordoma using protons or carbon ions in raster scan technique for primary or additive treatment after R2 resection. The evaluation is therefore based on the proportion of treatments without Grade 3-5 toxicity (CTCAE, version 4.0) up to 12 months after treatment and/or discontinuation of the treatment for any reason as primary endpoint. Local-progression free survival, overall survival and quality of life will be analyzed as secondary end points.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological confirmation of sacrococcygeal chordoma
- •Karnofsky performance status ≥ 70%
- •Patients age 18 - 80 years
- •Macroscopic tumour (MRI)
- •Written informed consent
排除标准
- •Lack of macroscopic tumour
- •Tumor extension in craniocaudal direction >16cm
- •Metal implants at the level of the tumor which could influence the treatment planning
- •Inability of the patient to lie quiet for at least 20 minutes (eg due to pain)
- •Prior radiotherapy of the pelvic region
- •Simultaneous participation in another trial that could influence the results of the study
- •Active medical implants without treatment approval at the time of ion irradiation (eg, cardiac pacemaker, defibrillator)
结局指标
主要结局
safety and feasibility of hypofractionated irradiation in patients with sacrococcygeal chordoma using ions (protons or carbon ions) in raster scan technique
时间窗: From date of treatment start until 12 months after treatment.
The evaluation is based on incidence of Grade 3-5 toxicity (NCI-CTC-AE) and/or discontinuation of the treatment for any reason. Endpoint is the proportion of treatments without Grade 3-5 toxicity (NCI-CTC-AE) up to 12 months after treatment and/or discontinuation of the treatment for any reason
次要结局
- local progression free survival (LPFS)(From date of treatment start until the date of first documented progression in MRI/CT scan assessed up to 12 months.)
- Quality of life (QoL)(From date of treatment start up to 12 months. Evaluation at treatment start, at the end of treatment and 12 months after treatment.)
- Overall survival (OS)(From date of treatment start until the date of death from any cause assessed up to 12 months.)
研究者
Klaus Herfarth, MD
Prof. Dr.
Heidelberg University