Hypofractionated Irradiation At Regional Nodal Area for Breast Cancer Vs Existed Standard Treatment

The main objective of this trial is to investigate the efficacy and safety of hypofractionated radiotherapy of 3 or 4 weeks by comparing with conventional radiotherapy of 5 or 6 weeks using intensity-modulated radiation therapy (IMRT) in breast cancer patients with an indication for regional nodal irradiation (RNI) following mastectomy or breast conserving surgery. Patients will be randomized to hypofractionated radiotherapy or conventional radiotherapy delivered to chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes). Eligible breast cancer patients will be followed for at least 5 years to evaluate the difference in 5-year locoregional recurrence, over survival, distant metastasis, toxicity and life quality between two groups.

NCT Number	NCT03829553
Lead Sponsor	Ruijin Hospital Collaborators: RenJi Hospital, Shanghai 10th People's Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai Zhongshan Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Affiliated Hospital of Jiangnan University, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
Conditions	Breast Cancer
Enrollment	801 participants
Start Date	2019-02-21
Primary Completion	2022-12 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2022-06-02