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Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation during surgery followed by external-beam radiation to the entire breast may kill more tumor cells.The clinical trial is conducting to compare the effectiveness of radiation therapy during surgery and whole-breast radiation therapy in treating women who have undergone breast-conversing surgery for Intermediate or high grade ductal carcinoma in situ breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraoperative Radiotherapy | Experimental | Boost with 20 Gy during BCS, EBRT with 46-50 Gy |
|
| whole breast radiation | Active Comparator | WRT:whole breast radiation after BCS with 46-50 Gy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative Radiotherapy | Radiation | Boost with 20 Gy during BCS, EBRT with 46-50 Gy |
|
| Measure | Description | Time Frame |
|---|---|---|
| ipsilateral breast tumor recurrence rate after surgery within five years | Within 5 years after surgery,we should evaluate ipsilateral breast tumor recurrence and Disease free survival as the most important outcome measure | Within 5 years after surgery |
| Disease free survival after surgery within five years | Within 5 years after adjuvant chemotherapy,we should evaluateDisease free survival(DFS) rates as thet important outcome measure. | Within 5 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival after surgery within ten years | After surgery,we should evaluate overall survival (OR)rates as the secondary important outcome measure. | Within ten years after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liao Ning, MD,PhD | Guangdong Academy of Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Academy of Medical Sciences | Guangzhou | Guangdong | 510080 | 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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| Whole breast radiation | Radiation | whole breast radiation after BCS with 46-50 Gy |
|
| D017437 |
| Skin and Connective Tissue Diseases |