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Intra-operative Radiotherapy For Breast Cancer Women After NSM

Primary Purpose

Breast Neoplasms

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

INTRABEAM (Carl Zeiss, Oberkochen, Germany)

About this trial

This is an interventional treatment trial for Breast Neoplasms focused on measuring Ductal carcinoma in situ （DCIS）, Nipple-sparing mastectomy (NSM), Intraoperative radiotherapy (IORT), INTRABEAM

Eligibility Criteria

17 Years - 80 Years (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Guangdong Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Without Radiotherapy

Intraoperative Radiotherapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Overall survival after surgery within ten years

After surgery,we should evaluate overall survival (OR)rates as the secondary important outcome measure.

Full Information

NCT ID

NCT02389686

First Posted

March 10, 2015

Last Updated

March 10, 2015

Sponsor

Liao Ning

1. Study Identification

Unique Protocol Identification Number

NCT02389686

Brief Title

Intra-operative Radiotherapy For Breast Cancer Women After NSM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Recruiting

Study Start Date

October 2014 (undefined)

Primary Completion Date

October 2019 (Anticipated)

Study Completion Date

October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Liao Ning

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Neoplasms

Keywords

Ductal carcinoma in situ （DCIS）, Nipple-sparing mastectomy (NSM), Intraoperative radiotherapy (IORT), INTRABEAM

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Without Radiotherapy

Arm Type

No Intervention

Arm Description

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

Arm Title

Intraoperative Radiotherapy

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

INTRABEAM (Carl Zeiss, Oberkochen, Germany)

Intervention Description

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

Primary Outcome Measure Information:

Title

Ipsilateral breast tumor recurrence rate after surgery within five years

Description

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 Outcome Measure Information:

Title

Disease free survival after surgery within five years

Description

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

Title

Overall survival after surgery within ten years

Description

After surgery,we should evaluate overall survival (OR)rates as the secondary important outcome measure.

Time Frame

Within ten years after surgery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

17 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Liao Ning, MD,PhD

Phone

+86 83827812

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Liao Ning, MD,PhD

Organizational Affiliation

Guangdong Academy of Medical Sciences

Official's Role

Study Director

Facility Information:

Facility Name

Guangdong Academy of Medical Sciences

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wen LingZhu

Phone

13763316144

dearecho@msn.com

12. IPD Sharing Statement

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Intra-operative Radiotherapy For Breast Cancer Women After NSM

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