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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hypofractionation radiotherapy | Experimental | irradiation 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. |
|
| conventional fractionation radiotherapy | Active Comparator | irradiation 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiotherapy | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| in-breast recurrence rate | evidence of ipsilateral breast local recurrence confirmed by histology | 5 year |
| Measure | Description | Time Frame |
|---|---|---|
| regional node recurrence rate | ipsilateral axillary node, internal mammary node and supraclavicular node recurrence confirmed by physical examination, image evaluation or histology. | 5 year |
| disease-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ye-xiong Li, M.D. | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Study Chair |
| Shu-lian Wang, M.D. | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing hospital | Beijing | Beijing Municipality | 100730 | China | ||
| Zhongshan Hospital Fudan University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32780661 | Derived | Wang SL, Fang H, Hu C, Song YW, Wang WH, Jin J, Liu YP, Ren H, Liu J, Li GF, Du XH, Tang Y, Jing H, Ma YC, Huang Z, Chen B, Tang Y, Li N, Lu NN, Qi SN, Yang Y, Sun GY, Liu XF, Li YX. Hypofractionated Versus Conventional Fractionated Radiotherapy After Breast-Conserving Surgery in the Modern Treatment Era: A Multicenter, Randomized Controlled Trial From China. J Clin Oncol. 2020 Nov 1;38(31):3604-3614. doi: 10.1200/JCO.20.01024. Epub 2020 Aug 11. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
locoregional relapse, distant relapse, death
| 5 year |
| overall survival | any death | 5 year |
| acute toxicity | radiation dermatitis and radiation pneumonitis evaluated and graded by CTC3.0 criteria | 6 months |
| late complication | breast cosmetic effect, ischemic heart disease, rib fracture, arm edema and shoulder joint dysfunction | 3 -10 year |
| Shanghai |
| Shanghai Municipality |
| 200032 |
| China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| Cancer Hospital, Chinese Academy of Medical Sciences | Beijing | 100021 | China |
| D017437 |
| Skin and Connective Tissue Diseases |