This non-inferiority, phase 3 clinical trial evaluates the cosmetic non-inferiority of a one-week regimen (26 Gy/5 Fx) versus a three-week regimen (40 Gy/15 Fx) using intensity-modulated radiation therapy (IMRT) for partial breast irradiation (PBI) in low-risk breast cancer patients post-breast-conserving surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
818
40.05Gy/15Fx/3w, 2.67Gy/Fx, once daily
26Gy/5Fx/1w, 5.2Gy/Fx, once daily
Fudan University Shanghai Cancer Center
Shanghai, China
RECRUITINGAdverse cosmesis
Adverse cosmetic outcome (defined as 'Fair' or 'Poor') was evaluated by an independent panel using standard photographic assessment based on the EORTC Cosmetic Rating System.
Time frame: 3 years
Locoregional recurrence
Locoregional recurrence is defined as the first documented recurrence in the ipsilateral breast or regional nodes.
Time frame: 5 years
Overall survival
Overall survival is the time from randomization to death from any cause.
Time frame: 5 years
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