The study was designed to investigate whether hypofractionated radiotherapy(HF-RT) is noninferior to conventionally fractionated radiotherapy (CF-RT) in terms of tumor loco-regional control for patients after breast conserving surgery
Eligible patients after breast conserving surgery will be randomized 1:1 into hypofractionated radiotherapy (HF-RT) group or conventionally fractionated radiotherapy (CF-RT) group. Patients in HF-RT group will receive 40 Gy/15 fractions irradiation to the whole breast with/without regional lymphnodes within 3 weeks and the tumor bed is boosted to 48 Gy/15 fractions simutaneously. Patients in CF-RT group will receive 50 Gy/ 25 fractions irradiation to whole breast with/without regional lymphnodes within 5 weeks and the tumor bed is boosted to 60 Gy/30 fractions sequentially. The primary endpoint is loco-regional recurrence. Other cancer related events and acute/late radiation morbidities will also be evaluated. The patients will be followed for 10 years. It is hypothesized that hypofractionated radiotherapy is non inferior to conventional fractionated radiotherapy in terms of tumor loco-regional control for patients after breast conserving surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4,052
daily fractions, 2.66 Gy/3.2 Gy per fraction to whole breast/tumor bed, five fractions per week
daily fractions, 2 Gy per fraction, five fractions per week
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
NOT_YET_RECRUITINGSuzhou Municipal hospital
Suzhou, Jiangsu, China
RECRUITINGThe Second Hospital of Dalian Medical University
Dalian, Liaoning, China
Loco-regional recurrence (LRR)
Defined as any clinical and biopsy-proven tumor recurrence involving the ipsilateral chest wall and/or regional nodes (including axillary, supraclavicular, infraclavicular, or internal mammary nodes).
Time frame: 5 years
Distant metastasis free survival (DMFS)
Distant metastasis is defined as clinical detection of metastatic disease beyond the chest wall and/or regional lymph nodes or death or last visit. Distant metastasis free survival (DMFS) is defined as the interval starting from the date of randomization until to the event.
Time frame: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years
Disease free survival (DFS)
Defined as the interval from the date of randomization to any disease recurrence or death or last visit.
Time frame: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years
Overall survival (OS)
Defined as the interval from the date of randomization to death or last visit.
Time frame: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years
Number of patients with radiation-induced acute toxicity assesses by CTCAE4.03
Acute toxicity (development of radiation dermatitis, pruritus, pain, radiation esophagitis, and radiation pneumonitis) will be assessed according to toxicity criteria of CTCAE version 4.03 before treatment, during treatment (after 8 fractions irradiation for HF-RTgroup and 15 fractions for CF-RT group) and the end of treatment (15 fractions irradiation for HF-RTgroup and 30 fractions for CF-RT group), 2 weeks and 3 months after the last fraction received.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Shanghai Huangpu District Central Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGFudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGTime frame: before treatment, after 8 fractions (HF-RTgroup) and 15 fractions (CF-RT and HF-RT groups) and 30 fractions（CF-RT group) irradiation, 2 weeks and 3 months after the irradiation finished
Number of patients with radiation-induced late toxicity assesses by CTCAE4.03
Late toxicity (change of skin in irradiated area，impaired shoulder movement ，impaired shoulder movement, brachial plexopathy,ischemic heart disease) will be assessed according to toxicity criteria of CTCAE version 4.03
Time frame: before treatment, every year after the last fraction received through 10 years
Number of patients with radiation-induced late toxicity assesses by LENT-SOMA Toxicity Assessment
Development of dyspigmentation, telangiectasia in irradiated area and radiation pulmonary fibrosis will be assessed according to toxicity criteria of LENT-SOMA
Time frame: before treatment, every year after the last fraction received through 10 years
Harvard/NSABP/RTOG Breast Cosmesis Grades of patients
The cosmetic outcomes will be evaluated by radiation oncologists, nurses and patients using digital photographs and Harvard/NSABP/RTOG Breast Cosmesis Grading Scale. Harvard/NSABP/RTOG Breast Cosmesis Grading Scale classifies the overall aesthetic results in four categories from excellent, good, fair to poor.
Time frame: before treatment, every year after the last fraction received through 10 years
Quality of Life Score assessed by EORTC-QLQ-C30 (version 3)
Patients' quality of life will be assessed using self-administered questionnaire EORTC-QLQ-C30 (version 3)
Time frame: before treatment, after 15 fractions (HF-RTgroup) or 30 fractions (CF-RT group) irradiation，every year after the treatment finished through 10 years
Quality of Life Score assessed by EORTC breast-cancer module (BR23)
Patients' quality of life will be assessed using self-administered questionnaire EORTC breast-cancer module (BR23)
Time frame: before treatment, after 15 fractions (HF-RTgroup) or 30 fractions (CF-RT group) irradiation, every year after the last fraction received through 10 years
Number and percentage of peripheral blood lymphocytes
peripheral blood lymphocytes will be assessed before, during treatment (after 8 fractions irradiation for HF-RTgroup and 15 fractions for CF-RT group) and the end of treatment (15 fractions irradiation for HF-RTgroup and 30 fractions for CF-RT group). The number and percentage of peripheral blood lymphocytes will be assessed the correlation with the grade of acute toxicity assessed by CTCAE 4.03
Time frame: before treatment, after 8 fractions (HF-RTgroup) and 15 fractions (CF-RT and HF-RT groups) and 30 fractions（CF-RT group) irradiation