Intra-operative Radiotherapy For Breast Cancer Women After NSM

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Device: INTRABEAM (Carl Zeiss, Oberkochen, Germany)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Tumor diameter ≤3 cm Tumor from the papilla>2cm Low grade ductal carcinoma in situ Candidate for breast-conserving surgery Must have undergone lumpectomy with negative margins or minimal margin involvement Currently undergoing re-excision of the biopsy cavity and/or sentinel lymph node biopsy or axillary lymph node dissection No evidence of metastatic disease Informed consent Exclusion Criteria: No informed consent Tumor size > 3 cm Tumor from the papilla≤2cm Intermediate or high grade ductal carcinoma in situ Invasive carcinoma No indication for a boost

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Without Radiotherapy<br>Patients just accept nipple-sparing mastectomy (NSM) without radiotherapy. | |
| Experimental: Intraoperative Radiotherapy<br>Followed by nipple-sparing mastectomy (NSM),INTRABEAM IORT was carried out with a single dose of 16 Gy for nipple-areola complex (NAC). | Device: INTRABEAM (Carl Zeiss, Oberkochen, Germany)<br>* Boost with 16 Gy during NSM for nipple-areola complex (NAC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | After surgery,we should evaluate overall survival (OR)rates as the secondary important outcome measure. | Within ten years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ductal carcinoma in situ （DCIS）, Nipple-sparing mastectomy (NSM), Intraoperative radiotherapy (IORT), INTRABEAM