Spots Global Cancer Trial Database for Intra-operative Radiotherapy For Breast Cancer Women After NSM

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Trial Identification

Brief Title: Intra-operative Radiotherapy For Breast Cancer Women After NSM

Official Title: Intra-operative Radiotherapy For Women With Ductal Carcinoma in Situ Breast Cancer After Nipple-sparing Mastectomy

Study ID: NCT02389686

Conditions

Breast Neoplasms

Interventions

INTRABEAM (Carl Zeiss, Oberkochen, Germany)

Study Description

Brief Summary: 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.

Detailed Description: 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.