Validation of Prone Crawl Radiotherapy for Whole-breast Irradiation After Breast Conserving Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Setup error
研究概览
简要总结
The aim of this study is to validate the obtained results of setup precision, comfort and setup time. The possibility of using breath hold for heart sparing in combination with prone crawl position will be tested. Forty patients (20 with left-sided and 20 with right-sided breast carcinoma) presenting for WBI without LNI after breast-conserving surgery will be included after signing informed consent.
详细描述
This is a phase II non-randomized trial, where 40 patients will be treated for breast cancer requiring whole breast irradiation as per standard of care. Patients will be simulated and treated using the novel prone crawl position to a total dose of 40.05 Gy in 15 fractions of 2.67 Gy.
The trial aims to evaluate setup precision, patient comfort and setup time in the prone crawl positioning. Feasibility of deep inspiration breathhold will be tested and dosimetric parameters evaluated.
This is done through registration of setup errors at the time of treatment, questionnaires for comfort/discomfort scoring, time registration, toxicity scoring, and dosimetric analysis in treatment planning systems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Female patients
- •Non-metastasized breast carcinoma
- •Multidisciplinary decision of adjuvant radiotherapy after lumpectomy for breast cancer
- •Prone WBI without LNI indicated according to the department's guidelines, treatment schedule of at least 15 fractions
- •Age ≥ 18 years
- •Informed consent obtained, signed and dated before specific protocol procedures
排除标准
- •< 18 years old
- •Mastectomy
- •Need for LNI
- •Bilateral breast irradiation
- •Partial breast irradiation
- •Unable to be treated in prone position
- •Less than 15 treatment fractions planned
- •Situs inversus
- •Pregnant or breastfeeding
- •Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
- •Patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study
结局指标
主要结局
Setup error
时间窗: During the intervention
Setup errors are analyzed using Van Herk parameters obtained by rigid coregistration of treatment imaging with simulation imaging
次要结局
- Setup Time(During the intervention)
- Reproducibility of DIBH(At baseline)
- Patient comfort(immediately after the intervention)
- Acute toxicity(6 months after treatment end)
- Dose to target and dose to organs at risk(Before treatment initiation after CT simulation)