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The role of NSM is still controversial, mainly because of concern about the oncologic safety of the nipple-areola complex (NAC).INTRABEAM (Carl Zeiss, Oberkochen, Germany) is the most widely used mobile intraoperative radiotherapy (IORT) device to date. This study aims to assess the value of the INTRABEAM system for breast cancer.
Despite the advancement and increasing use of nipple-sparing mastectomy (NSM) is still carried out in a portion of breast cancer patients. However, the role of NSM is still controversial, mainly because of concern about the oncologic safety of the nipple-areola complex (NAC). 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.INTRABEAM (Carl Zeiss, Oberkochen, Germany) is the most widely used mobile intraoperative radiotherapy (IORT) device to date. This study aims to broaden the application of the INTRABEAM system for breast cancer, investigating the feasibility of INTRABEAM IORT in NSM with breast reconstruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Without Radiotherapy | No Intervention | Patients just accept nipple-sparing mastectomy (NSM) without radiotherapy. | |
| Intraoperative Radiotherapy | Experimental | Followed by nipple-sparing mastectomy (NSM),INTRABEAM IORT was carried out with a single dose of 16 Gy for nipple-areola complex (NAC). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INTRABEAM (Carl Zeiss, Oberkochen, Germany) | Device | Boost with 16 Gy during NSM for nipple-areola complex (NAC) |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Overall survival after surgery within ten years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liao Ning, MD,PhD | Contact | +86 83827812 |
| 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 | Recruiting | Guangzhou | Guangdong | 510080 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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After surgery,we should evaluate overall survival (OR)rates as the secondary important outcome measure. |
| Within ten years after surgery |
| D017437 |
| Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |