Intra-operative Radiotherapy For Breast Cancer Women After NSM

March 10, 2015 updated by: Liao Ning

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Liao Ning, MD,PhD
  • Phone Number: +86 83827812

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Guangdong Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 5 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 5 years after surgery
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.
Within ten years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liao Ning

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ANTICIPATED)

October 1, 2019

Study Completion (ANTICIPATED)

October 1, 2024

Study Registration Dates

First Submitted

March 10, 2015

First Submitted That Met QC Criteria

March 10, 2015

First Posted (ESTIMATE)

March 17, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

March 17, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GGHBCRG-IORT-NSM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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