Evaluation of CPAP (Continuous Positive Airway Pressure) in the Planning of Radiation Treatments for Lung, Upper Abdomen and Left Breast Cancers
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Reduction in amplitude of tumor motion
研究概览
简要总结
This is a clinical study on patients to compare the effects of CPAP on lung volume diaphragm motion, heart position and tumor motion compared to free breathing. Only patients with significant tumor motion of greater than 1 cm amplitude or unfavorable chest wall geometry (heart close to chest wall) identified on standard imaging and simulation will be candidates for the study. Patients will be re- simulated and planned for radiation treatments with CPAP. The radiation plans generated with and without CPAP will be compared to evaluate the impact of CPAP on tumor motion and dose delivered to adjacent critical structures such as the heart and lung.
详细描述
Primary Objectives
- Evaluate effectiveness of CPAP to reproducibly reduce tumor and organ motion during radiation therapy treatments.
- Determine if CPAP allows for a reduction in normal tissue receiving radiation in chest and abdomen tumors and reduce heart exposure for patients receiving left breast irradiation.
Entry Criteria: This is a proof of concept and feasibility study. We propose to study 10 patients in each group for a total of thirty patients.
Eligibility criteria Group1. Lung tumors and nodules with tumor motion greater than 1 cm on standard imaging (n=10) Group2. Left sided breast tumors with unfavorable anatomy, viz heart abutting chest wall (n=10) Group3. Upper abdominal tumors: Liver and Pancreas with tumor motion greater than 1 cm. (n=10)
Pretreatment evaluations/management for patients meeting eligibility criteria CPAP All patients will be evaluated by a pulmonologist for their respiratory performances including physical examination, oxygen saturation and pulmonary function tests including DLCO that will serve for baseline measures. Then, adjustment session will be performed aiming to get adjusted to a CPAP device till the maximal tolerated pressure is not more than 16 cmH20 (TBD) for 30 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Lung tumors and nodules with tumor motion greater than 1 cm on standard imaging
- •Left sided breast tumors with unfavorable anatomy, viz heart abutting chest wall
- •Upper abdominal tumors: Liver and Pancreas with tumor motion greater than 1 cm. (n=10)
排除标准
- •Under 18 years old
- •Inability to sign informed consent
- •Pregnancy,
- •Mental Illness,
- •Not legally competent
结局指标
主要结局
Reduction in amplitude of tumor motion
时间窗: 2 months
Measurement of the Internal Target Volume in cc
次要结局
- Reduction of radiation dose to critical organs(2 months)
研究者
Dr. Zvi Symon MD
Chairman Radiation Oncology
Sheba Medical Center
