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Hypofractionated versus conventional intensity-modulated radiation irradiation (HARVEST-adjuvant): study protocol for a randomised non-inferior multicentre phase III trial.
Xie, Jinrong; Xu, Feifei; Zhao, Yutian; Cai, Gang; Lin, Xiao; Zhu, Qiwei; Lin, Qing; Yao, Yuan; Xu, Cheng; Cai, Rong; Wang, Shubei; Tang, Xiaolu; Chen, Chuying; Zheng, Siyue; Chen, Mei; Chen, Min; Qian, Xiaofang; Shen, Chunhong; Li, Jian; Xu, Haoping; Xu, Fei; Han, Yimin; Li, Min; Ou, Dan; Shen, Kun Wei; Qi, Wei-Xiang; Cao, Lu; Huang, Xiaobo; Chen, Jiayi.
Afiliação
  • Xie J; Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China.
  • Xu F; Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China.
  • Zhao Y; Department of Radiation Oncology, Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China.
  • Cai G; Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China.
  • Lin X; Yat-Sen Breast Tumor Hospital, Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University, Guangzhou, Guangdong, China.
  • Zhu Q; 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.
  • Lin Q; Department of Radiation Oncology, Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu, China.
  • Yao Y; Department of Radiation Oncology, Shanghai Tenth People's Hospital, Shanghai, Shanghai, China.
  • Xu C; Department of Radiation Oncology, Shanghai Jiao Tong University School of Medicine Affiliated Ninth People's Hospital, Shanghai, Shanghai, China.
  • Cai R; Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China.
  • Wang S; Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China.
  • Tang X; Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China.
  • Chen C; Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China.
  • Zheng S; Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China.
  • Chen M; Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China.
  • Chen M; Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China.
  • Qian X; Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China.
  • Shen C; Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China.
  • Li J; Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China.
  • Xu H; Clinical Research Centre, Ruijin Hospital, Shanghai Jiaotong university School of Medicine, Shanghai, Shanghai, China.
  • Xu F; Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China.
  • Han Y; Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China.
  • Li M; Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China.
  • Ou D; Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China.
  • Shen KW; Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China.
  • Qi WX; Department of General Surgery, Comprehensive Breast Health Centre, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China.
  • Cao L; Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China.
  • Huang X; Department of Radiation Oncology, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, Shanghai, Shanghai, China.
  • Chen J; Yat-Sen Breast Tumor Hospital, Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University, Guangzhou, Guangdong, China.
BMJ Open ; 12(9): e062034, 2022 09 01.
Article em En | MEDLINE | ID: mdl-36581983
ABSTRACT

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 11 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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Lesões por Radiação / Neoplasias da Mama / Radioterapia de Intensidade Modulada Tipo de estudo: Clinical_trials / Etiology_studies Aspecto: Ethics / Patient_preference Limite: Female / Humans País/Região como assunto: Asia Idioma: En Revista: BMJ Open Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Lesões por Radiação / Neoplasias da Mama / Radioterapia de Intensidade Modulada Tipo de estudo: Clinical_trials / Etiology_studies Aspecto: Ethics / Patient_preference Limite: Female / Humans País/Região como assunto: Asia Idioma: En Revista: BMJ Open Ano de publicação: 2022 Tipo de documento: Article