PT  - JOURNAL ARTICLE
AU  - Liu, Jing
AU  - Tan, Yuting
AU  - Bi, Zhuofei
AU  - Huang, Suning
AU  - Zhang, Na
AU  - Zhang, An-du
AU  - Zhao, Lina
AU  - Wang, Yu
AU  - Liang, Zibin
AU  - Hou, Yu
AU  - Xu, Xiangying
AU  - Chen, Jianying
AU  - Wang, Fei
AU  - Lan, Xiaowen
AU  - Lin, Xiao
AU  - Zhang, Xiaoxue
AU  - Zhou, Wenyi
AU  - Ye, Xuting
AU  - Guo, Jian-gui
AU  - Wang, Xiaohong
AU  - Ding, Ran
AU  - Chen, Jiayi
AU  - Huang, Xiaobo
TI  - <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
AID  - 10.1136/bmjopen-2023-078049
DP  - 2024 Jul 01
TA  - BMJ Open
PG  - e078049
VI  - 14
IP  - 7
4099  - http://bmjopen.bmj.com/content/14/7/e078049.short
4100  - http://bmjopen.bmj.com/content/14/7/e078049.full
SO  - BMJ Open2024 Jul 01; 14
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.