Intra-operative Radiotherapy For Women With Ductal Carcinoma in Situ Breast Cancer
NCT ID: NCT02389673
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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RECRUITING
NA
222 participants
INTERVENTIONAL
2014-10-31
2026-06-30
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 breast-conversing surgery without radiotherapy.
No interventions assigned to this group
Intraoperative Radiotherapy
Boost with 20 Gy during BCS, EBRT with 46-50 Gy
Intraoperative Radiotherapy
Boost with 20 Gy during BCS, EBRT with 46-50 Gy
Interventions
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Intraoperative Radiotherapy
Boost with 20 Gy during BCS, EBRT with 46-50 Gy
Eligibility Criteria
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Inclusion Criteria
* 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 \> 5 cm
* Intermediate or high grade ductal carcinoma in situ
* Invasive carcinoma
* No indication for a boost
18 Years
70 Years
FEMALE
No
Sponsors
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Liao Ning
OTHER
Responsible Party
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Liao Ning
Guangdong Academy of Medical Sciences
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-DCIS
Identifier Type: -
Identifier Source: org_study_id
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