Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China.
Department of Radiation Oncology, Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China.
BMJ Open. 2022 Sep 1;12(9):e062034. doi: 10.1136/bmjopen-2022-062034.
Short course regimen has become the major trend in the field of adjuvant radiotherapy for patients with breast cancer. Hypofractionated radiotherapy (HF-RT) regimen of 40-42.5 Gy in 15-16 fractions has been established as a preferred option for whole breast irradiation. However, few evidences of hypofractionated regional nodal irradiation (RNI), especially involving internal mammary nodes (IMNs), could be available during the era of intensity-modulated radiation therapy (IMRT). Against this background, we design this trial to explore the hypothesis that HF-RT regimen involving RNI (including infraclavicular, supraclavicular nodes and IMNs) will be non-inferior to a standard schedule by using IMRT technique.
This is an open-label randomised, non-inferior, multicentre phase III trial. Patients with breast cancer with an indication for RNI after breast conserving surgery or mastectomy are randomised at a ratio of 1:1 into the following two groups: hypofractionated regimen of 2.67 Gy for 16 fractions or conventional regimen of 2 Gy for 25 fractions. The dose was prescribed to ipsilateral chest wall or whole breast and RNI (including infraclavicular, supraclavicular nodes and IMNs, lower axilla if indicated). The trial plans to enrol a total of 801 patients and all patients will be treated using IMRT technique. The primary endpoint is 5-year locoregional recurrence. The secondary endpoints include 5-year distant metastasis free survival, invasive recurrence-free survival, overall survival, accumulative acute radiation-induced toxicity and accumulative late radiation-induced toxicity, cosmetic outcomes and quality of life.
The study has been approved by the Ethical Committee of Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine (version 2018-95-3) and approvals from ethical committee of each participating centre have also been obtained. Research findings will be submitted for publication in peer-reviewed journals.
NCT03829553.
短程治疗方案已成为乳腺癌辅助放疗领域的主要趋势。40-42.5Gy 的分割剂量（15-16 次分割）已成为全乳照射的首选方案。然而，在调强放疗（IMRT）时代，关于局部区域淋巴结照射（RNI），特别是内乳淋巴结（IMNs）的分割剂量的证据较少。在此背景下，我们设计了这项试验，旨在探索以下假设：采用 IMRT 技术的 RNI（包括锁骨下、锁骨上淋巴结和 IMNs）短程治疗方案不劣于标准方案。
这是一项开放标签、随机、非劣效、多中心 III 期试验。接受保乳手术或乳房切除术的乳腺癌患者，按 1:1 的比例随机分为以下两组：16 次分割的 2.67Gy 短程治疗方案或 25 次分割的 2Gy 常规治疗方案。处方剂量为同侧胸壁或全乳和 RNI（包括锁骨下、锁骨上淋巴结和 IMNs，如果需要，还包括腋窝下部）。该试验计划共纳入 801 例患者，所有患者均采用调强放疗技术进行治疗。主要终点为 5 年局部区域复发率。次要终点包括 5 年无远处转移生存率、无侵袭性复发生存率、总生存率、累积急性放射性诱导毒性和累积晚期放射性诱导毒性、美容效果和生活质量。
本研究已获得上海交通大学医学院附属瑞金医院伦理委员会（版本 2018-95-3）的批准，各参与中心的伦理委员会也已批准。研究结果将提交同行评议期刊发表。
NCT03829553。
