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In this study,the eligible breast cancer patients will be randomized divided into two groups. the study group receive the accelerated hypo-fractioned whole breast irradiation with a concurrent boost to the tumor bed (WBI 2.5Gy x18 and SIB 2.88Gy x18) and the control group receive conventional fractioned whole breast irradiation with a concurrent boost to the tumor bed(WBI 1.8Gy x28 and SIB 2.15Gy x28). All radiotherapy will be delivered by external beam-intensity modulated radiotherapy. the purpose of this study is to assess whether the accelerated hypo-fractioned is non-inferior to the conventional fractionated radiotherapy. The outcomes evaluation will include acute toxicity , late toxicity including breast fibrosis and cardiac disease, cosmetic outcome ,local control and survival outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HF WBI-SIB breast radiation | Experimental | WBI-SIB breast radiation(WBI 2.5Gy x18 and SIB 2.88Gy x18) |
|
| CF WBI-SIB breast radiation | Placebo Comparator | WBI-SIB breast radiation(WBI 1.8Gy x28 and SIB 2.15Gy x28) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole Breast irradiation Plus simultaneous tumor bed Boost | Radiation | hypo-fractionated irradiation for experimental group and normal fractionated irradiation for comprator group |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of acute skin toxicity | To determine the acute toxicity of accelerated hypo-fractionated whole breast irradiation with concurrent boost to the tumor bed in 18 fractions and whether it will be non-inferior to the conventional fractionated WBI with a concurrent boost | 2 Weeks after the end of radiotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| local control | To determine the local control in women with early stage breast cancer treated with accelerated hypo-fractionated whole breast irradiation with concurrent boost to the tumor bed in 18 fractions and whether it will be non-inferior to the conventional fractionated WBI with a concurrent boost | From data of randomization until 60 months after the end of radiotherapy of last patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Xu | Contact | +86-531-67626132 | xumin7799@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiyan Road No.440 | Recruiting | Jinan | Shandong | 250117 | China |
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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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| Degree of chronic skin toxicity and cosmesis after radiotherapy | To assess the chronic skin toxicity and measure cosmesis using the Harvard cosmoses scale in patients and to determine whether the accelerated hypo-fractionated WBI with a concurrent boost is non-inferior to standard WBI with concurrent boost. | 6 months after radiotherapy |
| Degree of chronic skin toxicity and cosmesis after radiotherapy | To assess the chronic skin toxicity and measure cosmesis using the Harvard cosmoses scale in patients and to determine whether the accelerated hypo-fractionated WBI with a concurrent boost is non-inferior to standard WBI with concurrent boost. | 2 years after radiotherapy |
| Degree of chronic skin toxicity and cosmesis after radiotherapy | To assess the chronic skin toxicity and measure cosmesis using the Harvard cosmoses scale in patients and to determine whether the accelerated hypo-fractionated WBI with a concurrent boost is non-inferior to standard WBI with concurrent boost. | 5 years after radiotherapy |
| overall survival | To determine whether the overall survival after hypo-fractionated breast radiation with concurrent boost is non-inferior to conventional fractionated radiation therapy with concurrent boost. | From date of randomization until 60 months after the end of radiotherapy of last patients |
| D017437 |
| Skin and Connective Tissue Diseases |