Early-stage breast cancer patients treated with breast conservative surgery are enrolled in this study if they meet defined criteria. Patients are randomized into two groups: conventional fractionation radiotherapy and hypofractionated radiotherapy.The hypothesis is that conventional fractionation radiotherapy and hypofractionated radiotherapy have similar efficacy and toxicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
720
one group receives radiation to the whole breast to a total dose of 43.5Gy,at 2.9Gy per fraction, 5 fractions a week, followed by tumor bed boost of 8.7Gy, at 2.9Gy per fraction 5 fractions a week. the other group receives radiation to the whole breast to a total dose of 50Gy,at 2.0Gy per fraction, 5 fractions a week, followed by tumor bed boost of 10Gy, at 2.0Gy per fraction 5 fractions a week.
Beijing hospital
Beijing, Beijing Municipality, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
in-breast recurrence rate
evidence of ipsilateral breast local recurrence confirmed by histology
Time frame: 5 year
regional node recurrence rate
ipsilateral axillary node, internal mammary node and supraclavicular node recurrence confirmed by physical examination, image evaluation or histology.
Time frame: 5 year
disease-free survival
locoregional relapse, distant relapse, death
Time frame: 5 year
overall survival
any death
Time frame: 5 year
acute toxicity
radiation dermatitis and radiation pneumonitis evaluated and graded by CTC3.0 criteria
Time frame: 6 months
late complication
breast cosmetic effect, ischemic heart disease, rib fracture, arm edema and shoulder joint dysfunction
Time frame: 3 -10 year
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