BReath hOld TecHniquEs for Radiotherapy of Esophageal Carcinoma; a Feasibility Study - Part 1
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Reproducibility DIBH
研究概览
简要总结
The main objective of the first part of the study is to determine the most optimal method for DIBH (active breathing control vs voluntary coached) and its reproducibility. Based on these findings, one of these methods will be selected for part 2 of this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Histologically proven esophageal cancer of the mid or distal esophagus
- •Scheduled for external-beam photon radiotherapy with curative intention.
- •Age >= 18 years
- •Written informed consent.
排除标准
- •Serious respiratory distress
- •Contra-indication for fiducial marker placement
- •Noncompliance with any of the inclusion criteria
研究组 & 干预措施
ABC DIBH
Active Breathing Controlled (ABC) technique for deep breath inspiration hold (DIBH)
干预措施: DIBH using ABC technique (Other)
VC DIBH
Voluntary Coached (VC) technique for deep breath inspiration hold (DIBH)
干预措施: DIBH using VC technique (Other)
结局指标
主要结局
Reproducibility DIBH
时间窗: Week 1, 2, 3, 4, 5 during radiotherapy
Diaphragm dome position within 1cm of the baseline CT Target coverage \>94% of the prescribed dose (at 98% of the ITV)
Feasibility DIBH
时间窗: Week 1, 2, 3, 4, 5 during radiotherapy
Breath hold maintained for \>20 seconds
次要结局
未报告次要终点