A Non Randomised Comparative Phase II Trial to Determine the Benefit of Continuous Positive Airway Pressure-assisted Radiotherapy vs Deep Inspiration Breath Hold in Breast Cancer and in Lung & Liver Stereotactic Ablative Body Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Radiotherapy Plan Selection
研究概览
简要总结
A phase II trial to determine the proportion of patients where the use of continuous positive airway pressure (CPAP) results in a superior radiation plan compared to standard planning procedures. The rationale for using CPAP with radiotherapy is based on its ability to increase the tidal volume, flatten the diaphragm thus reducing respiratory excursions.The resultant lung hyperinflation and reduced respiratory excursions can be harnessed for radiotherapy purposes by:
- Displacing the heart away from the radiotherapy field
- Reducing the volume of functional lung irradiated
- Reducing the radiotherapy target motion
CPAP has been shown to be superior to free breathing radiotherapy (RT), however it remains unclear how much benefit it confers vs other motion management adjuncts such as deep inspiration breath hold (DIBH) or 4-DCT.
详细描述
PRIMARY OBJECTIVE:
To determine the proportion of patients where the use of CPAP results in a superior radiation plan compared to standard planning procedures in each patient cohort
SECONDARY OBJECTIVES
To determine:
- Impact of CPAP on treatment delivery time;
- Impact of CPAP on total lung volume;
- CPAP compliance;
- Patient experience;
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Any patient with pathologically-confirmed invasive breast cancer and planned for adjuvant radiotherapy to the breast or chest-wall with regional lymph node coverage
- •Any patient deemed suitable for lung or liver SABR as per departmental guidelines
- •Must have signed written informed consent
排除标准
- •Cannot tolerate CPAP e.g due to severe claustrophobia
- •Re-irradiation
结局指标
主要结局
Radiotherapy Plan Selection
时间窗: 6-12 months
To determine the proportion of patients where the use of continuous positive airway pressure (CPAP) results in a superior radiation plan compared to standard planning procedures in each patient cohort
次要结局
- Organ at Risk Dose Constraints(6-12 months)
- Compliance and Tolerability(6-12 months)