The study was designed to evaluate the feasibility and safety of hypofractionated partial breast irradiation after breast-conserving surgery for low-risk breast cancer patients.
A total dose of 40.05Gy in 15 fractions was delivered to the tumor bed for each eligible breast cancer patients. The endpoints including loco-regional recurrence, cosmetic outcomes, and toxicities, were evaluated after treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
220
deliver 40Gy/15Fx to tumor bed areas
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
The change of breast cosmetic outcome
The breast cosmetic outcome was measured by Harvard 4 scale (poor, moderate, good, excellent) evaluation system
Time frame: Baseline, and three years after the completion of radiation therapy
Acute radiation-induced toxicity assessed by CTCAE v4.0
acute toxicity related to skin and lung
Time frame: 3weeks, 5weeks,1 and 3 months after treatment beginning
Late complications
Complications related to radiation treatment after more than 3 months.
Time frame: 3 years
Ipsilateral breast tumor recurrence rate
The pathological confirmed tumor recurrence in the same breast
Time frame: 5 years
Local-regional recurrence
Disease recurrence in the ipsilateral chest wall or axillary, supraclavicular or infraclavicular fossa, or internal mammary chain.
Time frame: 5 years
Disease free survival
The interval from diagnosis to disease recurrence or death or last visit.
Time frame: 5 years
Overall survival
The interval from diagnosis to death or last visit
Time frame: 5 years
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