A randomised phase III study of radiation doses and fractionation schedules in non-low risk DCIS of the breast

非低风险乳腺导管原位癌 (DCIS) 放射剂量和分割方案的随机 III 期研究

• 批准号: nhmrc : 454390
• 负责人: A/Pr Rosemary Balleine
• 金额: $ 116.77万
• 依托单位: The University of Melbourne
• 依托单位国家: 澳大利亚
• 项目类别: NHMRC Project Grants
• 财政年份: 2007
• 资助国家: 澳大利亚
• 起止时间: 2007-01-01 至 2011-12-31
• 项目状态: 已结题
• 来源: https://researchdata.edu.au/randomised-phase-iii-dcis-breast/95362
• 关键词: randomised; phase; III; study; radiation

Treatment of ductal carcinoma in-situ (DCIS), a preinvasive form of breast cancer, is aimed at preventing invasive cancer recurrence. Women with higher-risk DCIS have an increased risk of recurrence. This study aims to individualise treatment for women with DCIS to achieve long-term tumour control with minimal treatment toxicity. After local excision of DCIS, radiotherapy (RT) to the whole breast reduces the recurrence rate. However, it is unclear if escalating radiation dose to the tumour bed in higher-risk women increases tumour control. It is also uncertain if giving fewer but larger radiation doses over 3-4 weeks would achieve the same tumour control as the standard 5-7 week course of RT to improve patient convenience and access to RT. Thus, this multicentre study of 610 women with higher-risk DCIS will investigate if adding a tumour bed radiation boost after whole breast RT improves tumour control, and the shorter RT course achieves the same tumour control as the standard longer course. Currently, the ability to predict the malignant potential of DCIS and RT toxicity is limited. This study will investigate if there are biological and genetic markers predictive of invasive recurrence and normal tissue toxicity in women with DCIS using state of the art technology. Women need to weigh up the likelihood of cancer control against adverse treatment effects to make an informed treatment decision. However, very little is known about the quality of life (QoL) consequences of the diagnosis and treatment of DCIS. In this study, the QoL, psychological distress, perceived risk of invasive cancer recurrence and perceived cosmetic outcomes of women with DCIS, will be assessed using a questionnaire of validated measures. This study will refine treatment for women with DCIS according to their risks of recurrence. It will significantly advance the understanding of the biology of DCIS and its psychological and QoL outcomes after treatment.

导管原位癌(DCIS)是乳腺癌的一种侵袭前形式，其治疗的目的是防止浸润性癌症的复发。患有高危DCIS的女性复发风险更高。这项研究的目的是对患有DCIS的妇女进行个体化治疗，以实现长期的肿瘤控制，并将治疗毒性降至最低。DCIS局部切除后，全乳房放疗可降低复发率。然而，目前尚不清楚高危女性肿瘤床辐射剂量的增加是否会增加肿瘤控制。同样不确定的是，在3-4周内给予更少但更大的放射剂量是否会达到与标准5-7周疗程的放疗相同的肿瘤控制效果，以改善患者的便利性和获得放疗的机会。因此，这项对610名患有高危DCIS的女性进行的多中心研究将调查在全乳腺放疗后增加肿瘤床放射增强是否能改善肿瘤控制，而较短的放疗疗程与标准的较长疗程实现了相同的肿瘤控制。目前，预测DCIS的恶性潜能和RT毒性的能力是有限的。这项研究将利用最先进的技术调查是否有生物学和遗传标记预测DCIS女性的侵袭性复发和正常组织毒性。女性需要权衡癌症控制的可能性和不良治疗效果，以做出知情的治疗决定。然而，人们对诊断和治疗DCIS的生活质量(QOL)的影响知之甚少。在这项研究中，生活质量、心理痛苦、浸润性癌症复发的感知风险和感知的美容结果将使用有效测量的问卷来评估。这项研究将根据DCIS复发的风险来改进对她们的治疗。这将极大地促进对DCIS生物学及其治疗后心理和生活质量结果的理解。