Intra-operative Radiotherapy For Breast Cancer Women After NSM

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02389686
• Other study ID #: GGHBCRG-IORT-NSM
• Status: Recruiting
• Phase: N/A
• First received: March 10, 2015
• Last updated: March 10, 2015
• Start date: October 2014
• Est. completion date: October 2024

Study information

• Verified date: March 2015
• Source: Guangdong Academy of Medical Sciences
• Contact: Liao Ning, MD,PhD
• Phone: +86 83827812
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: October 2024
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 17 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma in Situ
• Carcinoma, Intraductal, Noninfiltrating

Intervention

Device:
• INTRABEAM (Carl Zeiss, Oberkochen, Germany)
Boost with 16 Gy during NSM for nipple-areola complex (NAC)

Locations

Country	Name	City	State
China	Guangdong Academy of Medical Sciences	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Liao Ning

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes