Intra-operative Radiotherapy For Breast Cancer Women After NSM

  • STATUS
    Recruiting
  • End date
    Oct 21, 2024
  • participants needed
    110
  • sponsor
    Liao Ning
Updated on 21 January 2021
cancer
carcinoma
breast cancer
metastasis
carcinoma in situ
lumpectomy
ductal carcinoma in situ
axillary lymph node dissection
breast-conserving surgery
ductal carcinoma
sentinel lymph node biopsy

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.

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.

Details
Condition Breast Cancer, Breast Cancer, breast tumors, tumor of the breast, breast tumor
Treatment INTRABEAM (Carl Zeiss, Oberkochen, Germany)
Clinical Study IdentifierNCT02389686
SponsorLiao Ning
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

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 papilla2cm
Intermediate or high grade ductal carcinoma in situ
Invasive carcinoma
No indication for a boost
Clear my responses

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