Hypofractionated Ion Irradiation (Carbon Ions Versus Protons) of the Prostate
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- proctitis and cystitis
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 the prostate with carbon ions or protons using the raster scan technique.
详细描述
as published: Habl G, Hatiboglu G, Edler L, Uhl M, Krause S, Roethke M, Schlemmer HP, Hadaschik B, Debus J, Herfarth K: Ion Prostate Irradiation (IPI) - a pilot study to establish the safety and feasibility of primary hypofractionated irradiation of the prostate with protons and carbon ions in a raster scan technique. BMC cancer 2014, 14(1):202.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •histological proven carcinoma of the prostate with Gleason score risk of lymphe node involvement of <15% calculated by the Yale-formula; Risk [%] = [GS -5] x [PSA/3 + 1.5 x T], mit T = 0, 1, and 2 for cT1c, cT2a, und cT2b/cT2c
- •Karnofsky-Index ≥ 70%
- •age between 40 and 80 years
排除标准
- •Stadium IV (distant metastases) Lymphogenous Metastases hip replacement former irradiation of the pelvis pacemaker defibrillator
研究组 & 干预措施
protons
irradiation 20 x 3,3 GyE protons
干预措施: radiation (Procedure)
carbon ions
irradiation 20 x 3,3 GyE carbon ions
干预措施: radiation (Procedure)
结局指标
主要结局
proctitis and cystitis
时间窗: 3 years
via incidence grade 3-4 toxicity (NCI-CTC-AE)
次要结局
- OS(3 years)
- PSA-PFS(3 years)
- quality of life(3 years)
研究者
Klaus Herfarth, MD
Prof. Dr. Herfarth
Heidelberg University