Intra-operative Radiotherapy For Breast Cancer Women After NSM
1 other identifier
interventional
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 10, 2015
CompletedFirst Posted
Study publicly available on registry
March 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2024
CompletedMarch 17, 2015
March 1, 2015
5 years
March 10, 2015
March 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Disease free survival after surgery within five years
Within 5 years after surgery
Overall survival after surgery within ten years
Within ten years after surgery
Study Arms (2)
Without Radiotherapy
NO INTERVENTIONPatients just accept nipple-sparing mastectomy (NSM) without radiotherapy.
Intraoperative Radiotherapy
EXPERIMENTALFollowed by nipple-sparing mastectomy (NSM),INTRABEAM IORT was carried out with a single dose of 16 Gy for nipple-areola complex (NAC).
Interventions
Boost with 16 Gy during NSM for nipple-areola complex (NAC)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Liao Ninglead
Study Sites (1)
Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, 510080, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Liao Ning, MD,PhD
Guangdong Academy of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD,PhD
Study Record Dates
First Submitted
March 10, 2015
First Posted
March 17, 2015
Study Start
October 1, 2014
Primary Completion
October 1, 2019
Study Completion
October 1, 2024
Last Updated
March 17, 2015
Record last verified: 2015-03