A Prospective Trial to Compare Deep Inspiratory Breath Hold (DIBH) With Prone Breast Irradiation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Mean cardiac dose
研究概览
简要总结
This phase II trial studies how well deep inspiratory breath hold or prone breast radiation therapy works in reducing cardiac dose in patients with breast cancer or ductal carcinoma in situ. Deep inspiratory breath hold is a technique that involves a patient holding their breath during radiation to move the heart away from the breast to minimize radiation to the heart. Prone breast radiation therapy is a technique in which a patient receives treatment "face-down" to minimize the radiation to the rest of the body, including the heart and lungs. Comparing deep inspiratory breath hold to prone breast radiation therapy may help doctors improve radiation to the target while reducing radiation to healthy tissues surrounding the target.
详细描述
Patients attend a simulation visit and undergo two CT scans, one in the prone position and one in the supine position with DIBH. Within 1 week after the simulation visit, patients undergo radiation therapy either in the supine position with DIBH or in the prone position daily for 15-30 consecutive days as per physician's prescription
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Any woman with biopsy proven left breast DCIS or invasive cancer who has undergone a lumpectomy and who requires whole breast irradiation to the breast alone (and not to any nodal regions) as per the treating radiation oncologist
排除标准
- •Previous radiation to the ipsilateral breast
- •All pre-menopausal women will require a urine qualitative pregnancy test to exclude pregnancy; pregnant women will be excluded from the study
结局指标
主要结局
Mean cardiac dose
时间窗: Up to 6 weeks
Assess whether the mean cardiac dose in the supine DIBH plan differs from the mean cardiac dose in the prone plan within strata defined by total RT dose.
次要结局
- Mean left anterior descending artery (LAD) dose in DIBH plan vs. prone plan(Up to 6 weeks)
- Maximum left anterior descending artery (LAD) dose in DIBH plan vs. prone plan(Up to 6 weeks)
- Volume of ipsilateral lung receiving > 20Gy(Up to 6 weeks)
- Volume of the contralateral breast receiving > 5 Gy(Up to 6 weeks)
- Maximum point dose to planning target volume (PTV) breast(Up to 6 weeks)
- Change in distance between the chest wall and heart (at the most lateral portion of the chest-wall-heart interface)(Up to 6 weeks)
- Patient treatment plan (supine with DIBH or prone)(Up to 6 weeks)
- Distance from the mid-sternum to the nipple when the patient is in the prone position(Up to 6 weeks)
- PTV breast volume as calculated on the prone scan(Up to 6 weeks)
- Volume of heart receiving > 20 gray (Gy)(Up to 6 weeks)
- Maximum separation(Up to 6 weeks)
- Mean ipsilateral lung dose(Up to 6 weeks)