Hypofractionated versus conventional intensity-modulated radiation irradiation (HARVEST-adjuvant): study protocol for a randomised non-inferior multicentre phase III trial
Min Li,
Fei Xu,
Jian Li,
Min Chen,
Mei Chen,
Cheng Xu,
Yuan Yao,
Rong Cai,
Qing Lin,
Xiao Lin,
Yimin Han,
Feifei Xu,
Jinrong Xie,
Yutian Zhao,
Gang Cai,
Qiwei Zhu,
Shubei Wang,
Xiaolu Tang,
Chuying Chen,
Siyue Zheng,
Xiaofang Qian,
Chunhong Shen,
Haoping Xu,
Dan Ou,
Kun Wei Shen,
Wei-Xiang Qi,
Lu Cao,
Xiaobo Huang,
Jiayi Chen
Affiliations
Min Li
Center for Global Health, Nanjing Medical University School of Public Health, Nanjing, Jiangsu, China
Fei Xu
Dept. of Epidemiology, Nanjing Medical University School of Public Health, Nanjing, Jiangsu, China
Jian Li
Departments of Anaesthesiology, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu Province, China
Min Chen
1 Ophthalmology, Joint Shantou International Eye Center of Shantou University and The Chinese University, Shantou, People`s Republic of China
Mei Chen
Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China
Cheng Xu
associate professor
Yuan Yao
Department of Radiation Oncology, Shanghai Jiao Tong University School of Medicine Affiliated Ninth People`s Hospital, Shanghai, Shanghai, China
Rong Cai
Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China
Qing Lin
Department of Radiation Oncology, Shanghai Tenth People`s Hospital, Shanghai, Shanghai, China
Xiao Lin
Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Medical Research Centre, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China
Yimin Han
Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China
Feifei Xu
Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China
Jinrong Xie
Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China
Yutian Zhao
Department of Radiation Oncology, Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China
Gang Cai
Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China
Qiwei Zhu
Department of Radiation Oncology, Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu, China
Shubei Wang
Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China
Xiaolu Tang
Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China
Chuying Chen
Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China
Siyue Zheng
Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China
Xiaofang Qian
Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China
Chunhong Shen
Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China
Haoping Xu
Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China
Dan Ou
Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China
Kun Wei Shen
Department of General Surgery, Comprehensive Breast Health Centre, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China
Wei-Xiang Qi
Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China
Lu Cao
Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China
Xiaobo Huang
Department of Cardioloqy, Southern Medical University Nanfang Hospital, Guangzhou, Guangdong, China
Jiayi Chen
Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China
Introduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number NCT03829553.
