RT Journal Article
SR Electronic
T1 <span class="underline">R</span>ecur<span class="underline">I</span>ndex-<span class="underline">G</span>uided postoperative radiotherapy with or without <span class="underline">A</span>voidance of <span class="underline">I</span>rradiation of regional <span class="underline">N</span>odes in 1–3 node-positive breast cancer (RIGAIN): a study protocol for a multicentre, open-label, randomised controlled prospective, phase III trial
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e078049
DO 10.1136/bmjopen-2023-078049
VO 14
IS 7
A1 Liu, Jing
A1 Tan, Yuting
A1 Bi, Zhuofei
A1 Huang, Suning
A1 Zhang, Na
A1 Zhang, An-du
A1 Zhao, Lina
A1 Wang, Yu
A1 Liang, Zibin
A1 Hou, Yu
A1 Xu, Xiangying
A1 Chen, Jianying
A1 Wang, Fei
A1 Lan, Xiaowen
A1 Lin, Xiao
A1 Zhang, Xiaoxue
A1 Zhou, Wenyi
A1 Ye, Xuting
A1 Guo, Jian-gui
A1 Wang, Xiaohong
A1 Ding, Ran
A1 Chen, Jiayi
A1 Huang, Xiaobo
YR 2024
UL http://bmjopen.bmj.com/content/14/7/e078049.abstract
AB Introduction Postoperative radiotherapy in patients with breast cancer with one to three lymph node metastases, particularly within the pT1–2N1M0 cohort with a low clinical risk of local–regional recurrence (LRR), has incited a discourse surrounding personalised treatment strategies. Multigene testing for Recurrence Index (RecurIndex) model capably differentiates patients based on their level of LRR risk. This research aims to validate whether a more aggressive treatment approach can enhance clinical outcomes in N1 patients who possess a clinically low risk of LRR, yet a high RecurIndex-determined risk of LRR. Specifically, this entails postoperative whole breast irradiation combined with regional lymph node irradiation (RNI) following breast-conserving surgery or chest wall irradiation with RNI after mastectomy.Methods and analysis The RIGAIN (RecurIndex-Guided postoperative radiotherapy with or without Avoidance of Irradiation of regional Nodes in 1–3 node-positive breast cancer) Study is a multicentre, prospective, randomised, open-label, phase III clinical trial that is being conducted in China. In this study, patients with low clinical LRR risk but high RecurIndex-LRR risk are randomly assigned in a 1:1 ratio to the experimental group or the control group. In the experimental group, RNI is performed and the control group omits RNI. Efficacy and safety analyses will be conducted, enrolling a total of 540 patients (270 per group). The primary endpoint is invasive disease-free survival, and secondary endpoints include any first recurrence, LRR-free survival, distant metastasis-free survival, recurrence-free survival, overall survival, disease-free survival, breast cancer-specific mortality and assessment of patient quality of life. The study began in April 2023 and with a follow-up period of 60 months after the last participant completes radiation therapy.Ethics and dissemination The study was approved by the Ethics Committee of Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University (SYSKY-2022-097-02, V.3.1). It adheres to the Helsinki Declaration and Good Clinical Practice. Research findings will be submitted for publication in peer-reviewed journals.Trial registration number NCT04069884.