Intra-operative Radiotherapy For Breast Cancer Women After NSM

Liao Ning

Status: Enrolling

Conditions: Breast Neoplasms

Treatments: Device: INTRABEAM (Carl Zeiss, Oberkochen, Germany)

Study type: Interventional

Funder types: Other

Identifiers

NCT02389686

GGHBCRG-IORT-NSM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: Female

Ages: 17 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Without Radiotherapy

No Intervention group

Description:

Patients just accept nipple-sparing mastectomy (NSM) without radiotherapy.

Intraoperative Radiotherapy

Experimental group

Description:

Followed by nipple-sparing mastectomy (NSM),INTRABEAM IORT was carried out with a single dose of 16 Gy for nipple-areola complex (NAC).

Treatment:

Device: INTRABEAM (Carl Zeiss, Oberkochen, Germany)