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The study was designed to evaluate the feasibility and safety of hypofractionated whole-breast irradiation with simultaneously integrated boost for early-stage breast cancer after breast conserving surgery in Chinese population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HF-WBI | Experimental | Hypofractionated whole breast irradiation for early breast cancer with prescription dose 40Gy in 15 fractions in 3 weeks. Tumor bed is simultaneously integrated boosted to 48Gy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hypofractionated whole breast irradiation with simultaneously integrated boost | Radiation | deliver 40Gy/15Fx to whole breast with 48Gy/15fx simultaneously integrated to tumor bed |
| Measure | Description | Time Frame |
|---|---|---|
| Numbers of participants with treatment-related toxicity assessed by CTCAE v4.0 | acute toxicity related to irradiation such as lung and skin | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| acute radiation-induced toxicity assessed by CTCAE v4.0 | acute toxicity related to skin and lung | during radiotherapy; 3months; 6 months |
| local-regional recurrence | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoli Yu, MD | Contact | +86 13817893133 | stephanieyxl@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoli Yu, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Disease free survival | 5 years |
| Overall survival Over survival | 5 years |
| Late complications | 1,2,3,4,5years |
| cosmetic effect measured by Harvard 4 scale evaluation system | 2,3,4,5years |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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