Hypofractionated Whole-breast Irradiation With Simultaneously Integrated Boost For Early-Stage Breast Cancer After Breast-conserving Surgery
NCT ID: NCT02617043
Last Updated: 2017-05-02
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
PHASE2
200 participants
INTERVENTIONAL
2015-04-30
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HF-WBI
Hypofractionated whole breast irradiation for early breast cancer with prescription dose 40Gy in 15 fractions in 3 weeks. Tumor bed is simultaneously integrated boosted to 48Gy.
hypofractionated whole breast irradiation with simultaneously integrated boost
deliver 40Gy/15Fx to whole breast with 48Gy/15fx simultaneously integrated to tumor bed
Interventions
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hypofractionated whole breast irradiation with simultaneously integrated boost
deliver 40Gy/15Fx to whole breast with 48Gy/15fx simultaneously integrated to tumor bed
Eligibility Criteria
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Inclusion Criteria
* 18-60 years old
* Treated with breast conversing surgery and sentinel lymph node biopsy or axillary lymph node dissection
* Pathologically confirmed invasive breast cancer
* A pathological T1-2N0M0 tumor
* Tumor bed is labeled with Titanium clips
* Negative surgical margins
* Written informed consent.
Exclusion Criteria
* Treated with neoadjuvant chemotherapy
* Sentinel lymph nodes only containing isolated tumour cells (\<0.2 mm)
* With severe comorbidity
* Previous breast cancer or other malignant tumor history
* Previous radiotherapy for breast or thorax
* Medical contraindication for radiotherapy
* Pregnant or nursing
18 Years
60 Years
FEMALE
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Xiaoli Yu
Associate Professor of department of radiation oncology
Principal Investigators
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Xiaoli Yu, MD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FDRT-BC001
Identifier Type: -
Identifier Source: org_study_id
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