Breast Neoplasms
Conditions
Keywords
Ductal carcinoma in situ （DCIS）, Nipple-sparing mastectomy (NSM), Intraoperative radiotherapy (IORT), INTRABEAM
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.
Interventions
DEVICEINTRABEAM (Carl Zeiss, Oberkochen, Germany)
Boost with 16 Gy during NSM for nipple-areola complex (NAC)
Sponsors
Liao Ning
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
17 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ipsilateral breast tumor recurrence rate after surgery within five years | Within 5 years after surgery | Within 5 years after surgery,we should evaluate ipsilateral breast tumor recurrence and Disease free survival as the most important outcome measure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival after surgery within five years | Within 5 years after surgery | Within 5 years after adjuvant chemotherapy,we should evaluateDisease free survival(DFS) rates as thet important outcome measure. |
| Overall survival after surgery within ten years | Within ten years after surgery | After surgery,we should evaluate overall survival (OR)rates as the secondary important outcome measure. |
Countries
China
Contacts
Primary ContactLiao Ning, MD,PhD
Outcome results
None listed