Xie Jinrong, Zheng Siyue, Qi Wei-Xiang, Gan Lu, Yu Bo, Jiang Juan, Zhang Jie, Shi Yonggang, Dong Meilian, Cai Gang, Cai Rong, Xu Cheng, Xu Haoping, Qian Xiaofang, Zhang Yibin, Chen Mei, Cao Lu, Chen Jiayi
Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, China.
Department of Oncology, Shanghai Jiaotong University School of Medicine Xinhua Hospital, Shanghai, China.
BMJ Open. 2025 May 15;15(5):e096677. doi: 10.1136/bmjopen-2024-096677.
INTRODUCTION: Shortening the duration of postoperative radiotherapy (RT) for breast cancer while maintaining efficacy and safety has become a significant trend. The 3-week regimen of 40-42.5 Gy in 15-16 fractions is now a preferred option in clinical practice. Following the publication of the 5-year outcomes from the Fast-Forward trial, interest in 1-week regimens has surged, prompting the initiation of multiple studies. However, trials exploring the 1-week regimen for regional nodal irradiation (RNI), especially involving internal mammary nodes (IMN), remain scarce. Additionally, the optimal fractionation scheme for tumour bed boost in the era of ultra-hypofractionated regimens is still debated. To address these gaps, we initiated the adjuvant regional nodal radiation therapy for one week in breast cancer (ARROW) trial to evaluate the feasibility of a 1-week regimen for RNI of 26 Gy in five fractions, with optional sequential tumour bed boost of 10.4 Gy in two fractions. The findings from our trial are expected to extend the application of ultra-hypofractionated regimens to include sequential tumour bed boosts and RNI, pioneering its use in IMN irradiation. METHODS AND ANALYSIS: The ARROW trial is an open-label, single-arm, multicentre phase II trial, encompassing four teaching hospitals in China. Enrolled patients will receive a total of 26 Gy in five fractions to ipsilateral whole breast/chest wall and regional regions, including supraclavicular/infraclavicular nodes, IMN and any portion of the undissected axilla deemed at risk. A sequential tumour bed boost of 10.4 Gy in two fractions is delivered in patients at high risk for recurrence, which is at the discretion of the radiation oncologist. The sample size for the ARROW trial was 197 patients. Both intensity-modulated radiation therapy and proton therapy are permitted. The primary endpoint is acute radiation-induced toxicity, graded according to Radiation Therapy Oncology Group (RTOG) criteria and CTCAE V.3.0. Secondary endpoints include cosmetic outcomes for breast-conserving surgery, late radiation-induced toxicity, local regional recurrence, distant metastasis, invasive tumour-free survival, overall survival and quality-of-life assessment. ETHICS AND DISSEMINATION: The trial has been approved by the Ethical Committee of Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, as well as approvals from the ethical committees of each participating centre have also been obtained. Research findings will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ARROW trial: NCT04509648.
引言:在维持疗效和安全性的同时缩短乳腺癌术后放疗(RT)疗程已成为一个重要趋势。3周方案,即15 - 16次分割给予40 - 42.5 Gy,目前是临床实践中的首选方案。随着快速前进试验5年结果的公布,对1周方案的兴趣激增,促使开展了多项研究。然而,探索用于区域淋巴结照射(RNI)的1周方案的试验,尤其是涉及内乳淋巴结(IMN)的试验仍然很少。此外,在超短程分割方案时代,瘤床加量的最佳分割方案仍存在争议。为填补这些空白,我们启动了乳腺癌1周辅助区域淋巴结放射治疗(ARROW)试验,以评估1周方案给予26 Gy分5次进行RNI的可行性,以及可选的序贯给予瘤床10.4 Gy分2次加量的可行性。我们试验的结果有望将超短程分割方案的应用扩展到包括序贯瘤床加量和RNI,开创其在内乳淋巴结照射中的应用。 方法与分析:ARROW试验是一项开放标签、单臂、多中心II期试验,在中国的四家教学医院开展。入组患者将接受同侧全乳/胸壁及区域,包括锁骨上/下淋巴结、内乳淋巴结以及任何被认为有风险的未清扫腋窝部分,共26 Gy分5次照射。对于复发高风险患者,由放射肿瘤学家决定序贯给予瘤床10.4 Gy分2次加量。ARROW试验的样本量为197例患者。允许使用调强放射治疗和质子治疗。主要终点是急性放射诱导毒性,根据放射治疗肿瘤学组(RTOG)标准和CTCAE V.3.0分级。次要终点包括保乳手术的美容效果、晚期放射诱导毒性、局部区域复发、远处转移、无侵袭性肿瘤生存、总生存和生活质量评估。 伦理与传播:该试验已获得上海交通大学医学院附属瑞金医院伦理委员会的批准,并且也已获得各参与中心伦理委员会的批准。研究结果将提交至同行评审期刊发表。 试验注册号:ARROW试验:NCT04509648。
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