A randomised controlled trial comparing intraoperative to conventional radiotherapy in women with early beast cancer.

随着澳大利亚乳房筛查的出现，许多妇女被诊断出患有小的低风险癌症，可以用保乳疗法治疗，效果良好。在这种情况下，手术和放疗是为了尽量减少局部复发的风险。现在的问题是，我们是否可以为个别患者量身定制放疗，而不是向所有患者推荐每天6-7周的标准外束放疗。这项试验旨在回答这个问题，因为一种新的装置可以在术中进行一次放射治疗，现在已经经过测试，证明在乳房中使用是安全的。本试验的主要目的是证明，对于适合保乳治疗的早期低危乳腺癌妇女，术中单剂量放疗（IORT）与标准外束放疗具有相同的局部控制率。其他目标包括比较两种治疗方法；无病总生存率、美容结果、患者满意度偏好、生活质量和成本效益。如果研究发现保乳手术后单独IORT与标准外束放疗一样有效实现局部控制，那么对患者的主要好处是缩短治疗时间，避免了6-7周的标准放疗。减少需要接受标准放射治疗的早期乳腺癌患者的数量也将使治疗中心和其他癌症患者受益，因为它减少了等待放射治疗的时间。消费者团体从一开始就支持这一概念，最近原本不支持的团体的支持程度有所增加。具有重要意义的是，该试验提供了一个机会，在允许IORT成为其他国家正在进行的标准治疗之前，正式调查在临床试验安全范围内提供IORT的有效性。

With the advent of breast screening in Australia many women are diagnosed with small low risk cancers that can be treated with breast conserving therapy with good outcomes. Surgery and radiotherapy in this situation are used to minimise the risk of local recurrence. It is now being questioned whether we can tailor radiotherapy to suit individual patients rather than recommending the daily 6-7 weeks of standard external beam radiotherapy to all patients. This trial aims to answer this question as a new device which can deliver radiotherapy intraoperatively in a single session has now been tested and proven safe to use in the breast. The main objective of this trial is to demonstrate that a single dose of radiotherapy delivered intraoperatively (IORT) gives an equivalent local control rate to standard external beam radiotherapy in women with early low risk breast cancer who are suitable for breast conserving therapy. Other objectives include comparing the two treatments with respect to; disease-free-overall survival, cosmetic outcome, patient satisfaction-preference, quality of life and cost benefit. If the study finds that IORT alone after breast conserving surgery is as effective in achieving local control as standard external beam radiotherapy, a major benefit to patients would be shorter treatment duration by avoiding the 6-7 weeks of standard radiotherapy. A reduction in the number of early breast cancer patients requiring access to standard radiotherapy would also benefit treatment centres and other cancer patients by reducing the waiting times for radiotherapy. Consumer groups have supported the concept from the beginning and there has been recent increase in level of support by originally unsupportive groups. Of great significance is this trial offers an opportunity to formally investigate the efficacy of delivering IORT in the safe confines of a clinical trial, before allowing it to become a standard treatment which is occurring in other countries.