Optimisation and Individualisation of Heart-Sparing Breast Radiotherapy Techniques (The HeartSpare Study)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Interfraction reproducibility of chest wall position (group A)
研究概览
简要总结
Radiotherapy (RT) has a major curative role in women with early breast cancer, and is recommended routinely after lumpectomy and selectively after mastectomy. It has contributed to a halving of breast cancer mortality in the UK over the last 2 decades despite ever-rising cancer incidence. RT in women with left-sided tumours often exposes the underlying heart to a damaging dose. The heart is very sensitive to RT, and there were 1-2 deaths from heart disease for every 100 breast cancer patients treated during the 1960s-70s. The situation has improved in recent years, but standard RT techniques still deliver significant radiation doses to heart tissue.
Two potentially simple techniques reduce heart dose. In one, women are taught to breathe in deeply and to hold their breath for about 20 seconds while RT is given. The downward movement of the diaphragm pulls the heart away from the RT beam. In the other technique, women lie on their fronts, instead of on their backs as they normally do for breast RT. In this position, the breast falls away from the rib cage and reduces exposure of the heart. Neither technique is routinely available to women receiving breast RT in the UK for reasons that this research aims to address. The investigators need to: 1) confirm that patient position can be reproduced with millimetre precision every day using these techniques, 2) minimise costs of equipment, time and personnel required to support such techniques, 3) select the most appropriate technique for different patients and 4) train staff in centres across the UK to deliver techniques safely and effectively. By addressing all of these issues, the study aims ultimately to make heart-sparing RT available to all UK women that might benefit from treatment, thereby significantly reducing the burden of heart disease in breast cancer survivors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Complete microscopic excision of early stage invasive ductal or lobular carcinoma (pT1-3b N0-1 M0) of the left breast following breast conservation surgery or mastectomy.
- •Recommendation for whole breast (groups A and B) or chest wall (Group A only) radiotherapy (with or without tumour bed boost)
- •Performance status ≤1
- •Patients able to tolerate breath-hold
排除标准
- •Requirement for nodal irradiation
- •Patients with micro- or macro-scopic disease on sentinel node biopsy who have not undergone completion axillary node clearance
- •Previous radiotherapy to any region above the diaphragm
结局指标
主要结局
Interfraction reproducibility of chest wall position (group A)
时间窗: End of radiotherapy (3-4 weeks)
The position of ipsilateral chest wall will be compared between the digitally reconstructed radiographs (derived from the planning CT) and the on-treatment electronic portal images and mean daily displacements calculated.
Difference in mean left anterior descending coronary artery (LAD) mean normal tissue dose (NTDmean) (group B)
时间窗: End of radiotherapy (3-4 weeks)
Using dose-volume histograms (DVHs) based on the planning scan and on-treatment CBCT imaging, mean LAD NTDmean will be compared for ABC_DIBH versus prone positioning.
次要结局
- Difference in NTDmean for heart, LAD, ipsilateral and whole lungs (group A)(End of radiotherapy (3-4 weeks))
- Comparison of standard deviation in mean LAD NTDmean over a treatment course (group B)(End of radiotherapy (3-4 weeks))
- Comparison of individual patient heart NTDmean differences by anatomical factors (group B)(End of radiotherapy (3-4 weeks))
- Difference in mean normal tissue doses (NTDmean) to heart, ipsilateral and whole lungs (group B)(End of radiotherapy (3-4 weeks))
- Difference in volumes of chest wall receiving 20Gy (Groups A and B)(End of radiotherapy (3-4 weeks))
- Interfraction reproducibility of chest wall position (groups A and B)(End of radiotherapy (3-4 weeks))
- Interfraction reproducibility of tumour bed position (groups A and B)(End of radiotherapy (3-4 weeks))
- Time and equipment costs (groups A and B)(End of study (2 years))
- Patient and radiographer satisfaction with positioning technique (groups A and B)(Weekly questionnaire)
