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Intra-operative Radiotherapy For Breast Cancer Women After NSM

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Guangdong Academy of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Liao Ning, Guangdong Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT02389686
First received: March 10, 2015
Last updated: NA
Last verified: March 2015
History: No changes posted
  Purpose
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.

Condition Intervention
Breast Neoplasms
Device: INTRABEAM (Carl Zeiss, Oberkochen, Germany)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intra-operative Radiotherapy For Women With Ductal Carcinoma in Situ Breast Cancer After Nipple-sparing Mastectomy

Resource links provided by NLM:


Further study details as provided by Guangdong Academy of Medical Sciences:

Primary Outcome Measures:
  • Ipsilateral breast tumor recurrence rate after surgery within five years [ Time Frame: 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 Outcome Measures:
  • Disease free survival after surgery within five years [ Time Frame: 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 [ Time Frame: Within ten years after surgery ]
    After surgery,we should evaluate overall survival (OR)rates as the secondary important outcome measure.


Estimated Enrollment: 110
Study Start Date: October 2014
Estimated Study Completion Date: October 2024
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Without Radiotherapy
Patients just accept nipple-sparing mastectomy (NSM) without radiotherapy.
Experimental: Intraoperative Radiotherapy
Followed by nipple-sparing mastectomy (NSM),INTRABEAM IORT was carried out with a single dose of 16 Gy for nipple-areola complex (NAC).
Device: INTRABEAM (Carl Zeiss, Oberkochen, Germany)
Boost with 16 Gy during NSM for nipple-areola complex (NAC)

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.
  Eligibility

Ages Eligible for Study:   17 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02389686

Contacts
Contact: Liao Ning, MD,PhD +86 83827812

Locations
China, Guangdong
Guangdong Academy of Medical Sciences Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Wen LingZhu    13763316144    dearecho@msn.com   
Sponsors and Collaborators
Liao Ning
Investigators
Study Director: Liao Ning, MD,PhD Guangdong Academy of Medical Sciences
  More Information

Responsible Party: Liao Ning, MD,PhD, Guangdong Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02389686     History of Changes
Other Study ID Numbers: GGHBCRG-IORT-NSM
Study First Received: March 10, 2015
Last Updated: March 10, 2015

Keywords provided by Guangdong Academy of Medical Sciences:
Ductal carcinoma in situ (DCIS)
Nipple-sparing mastectomy (NSM)
Intraoperative radiotherapy (IORT)
INTRABEAM

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on March 28, 2017