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

一项随机对照试验，比较早期兽癌女性的术中放疗与常规放疗。

• 批准号: nhmrc : 393703
• 负责人: Mrs Tammy Corica
• 金额: $ 58.28万
• 依托单位: The University of Western Australia
• 依托单位国家: 澳大利亚
• 项目类别: NHMRC Project Grants
• 财政年份: 2006
• 资助国家: 澳大利亚
• 起止时间: 2006-01-01 至 2010-12-31
• 项目状态: 已结题
• 来源: https://researchdata.edu.au/randomised-controlled-trial-beast-cancer/100507
• 关键词: randomised; controlled; trial; comparing; intraoperative

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.

随着乳腺癌筛查在澳大利亚的出现，许多妇女被诊断出患有小的低风险癌症，可以通过保乳治疗获得良好的结果。在这种情况下，手术和放射治疗用于最大限度地减少局部复发的风险。现在有人质疑，我们是否可以为个别患者量身定制放射治疗，而不是推荐所有患者每天进行6-7周的标准外照射放射治疗。这项试验旨在回答这个问题，因为一种可以在单次手术中提供放射治疗的新设备现已经过测试，并被证明可以安全地用于乳房。本试验的主要目的是证明，在适合保乳治疗的早期低风险乳腺癌女性中，术中单剂量放疗（IORT）的局部控制率与标准外照射放疗相当。其他目的包括比较两种治疗方法的无病总生存率、美容结局、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在实现局部控制方面与标准外照射放疗一样有效，则患者的主要受益将是通过避免6-7周的标准放疗来缩短治疗时间。减少需要接受标准放射治疗的早期乳腺癌患者的人数也将使治疗中心和其他癌症患者受益，因为这将减少放射治疗的等待时间。消费者团体从一开始就支持这一概念，而最初不支持的团体最近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，在允许其成为其他国家正在进行的标准治疗之前，正式研究在临床试验的安全范围内提供IORT的有效性。