Intra-operative Radiotherapy For Breast Cancer Women After NSM

Liao Ning110 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

Breast Neoplasms

Interventions

INTRABEAM (Carl Zeiss, Oberkochen, Germany)DEVICE

Boost with 16 Gy during NSM for nipple-areola complex (NAC)

Eligibility

Sex: FEMALEMin age: 17 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Guangdong Academy of Medical Sciences

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: Within 5 years after surgery

Secondary Outcomes

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.

Time frame: 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.

Time frame: Within ten years after surgery

Central Contacts

Liao Ning, MD,PhD

CONTACT

+86 83827812

Data from ClinicalTrials.gov

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