Intra-operative Radiotherapy For Breast Cancer Women After NSM
NCT ID: NCT02389686
Last Updated: 2015-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
110 participants
INTERVENTIONAL
2014-10-31
2024-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Without Radiotherapy
Patients just accept nipple-sparing mastectomy (NSM) without radiotherapy.
No interventions assigned to this group
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).
INTRABEAM (Carl Zeiss, Oberkochen, Germany)
Boost with 16 Gy during NSM for nipple-areola complex (NAC)
Interventions
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INTRABEAM (Carl Zeiss, Oberkochen, Germany)
Boost with 16 Gy during NSM for nipple-areola complex (NAC)
Eligibility Criteria
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Inclusion Criteria
* 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
* Tumor size \> 3 cm
* Tumor from the papilla≤2cm
* Intermediate or high grade ductal carcinoma in situ
* Invasive carcinoma
* No indication for a boost
17 Years
80 Years
FEMALE
No
Sponsors
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Liao Ning
OTHER
Responsible Party
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Liao Ning
MD,PhD
Principal Investigators
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Liao Ning, MD,PhD
Role: STUDY_DIRECTOR
Guangdong Academy of Medical Sciences
Locations
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Guangdong Academy of Medical Sciences
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Liao Ning, MD,PhD
Role: CONTACT
Facility Contacts
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Other Identifiers
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GGHBCRG-IORT-NSM
Identifier Type: -
Identifier Source: org_study_id
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