The purpose of this study is to validate whether clinically low-risk, and RecurIndex high-risk N1 patients receiving regional lymph node radiotherapy can further improve clinical outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
540
external-beam radiotherapy (XRT)
Whole Breast Irradiation
chestwall irradiation
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
RECRUITINGInvasive disease-free survival (IDFS)
defined as the time between randomization and either local recur, distant metastases or death occurred
Time frame: 5 years
Any first recurrence (AFR)
defined as any recurrence of ipsilateral chest, breast, regional lymph node recurrence, or distant metastases by Imaging or pathology
Time frame: 5 years
Local-regional recurrence free survival (LRFS)
defined as time between randomization and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred
Time frame: 5 years
Distant metastasis free survival (DMFS)
defined as time between randomization and the time of distant metastases, or death occurred
Time frame: 5 years
Recurrence free survival (RFS)
defined as time between randomization and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred
Time frame: 5 years
Overall Survival (OS)
defined as time between randomization and the time of death occurred
Time frame: 5 years
Disease free survival (DFS)
defined as time between randomization and the time of disease recur or death occur
Time frame: 5 years
Beast cancer specific mortality (BCSM)
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defined as time between randomization and the time of death occur specific due to breast cancer
Time frame: 5 years
Patient life quality measurement
At the screening period and after the end of radiotherapy, each group of patients was enrolled in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Cancer-30 (C30)
Time frame: 5 years
Patient life quality measurement
At the screening period and after the end of radiotherapy, each group of patients was enrolled in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Breast-23 (BR23)
Time frame: 5 years