Axillary Radiotherapy for Early Stage Breast Cancer With Limited Positive Sentinel Lymph Nodes
NCT ID: NCT02612012
Last Updated: 2015-11-23
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
475 participants
OBSERVATIONAL
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Axillary radiotherapy
axillary radiotherapy
Whole breast irradiation and axillary level I-II areas radiotherapy. The prescription dose is 50Gy in 25 fractions in 5 weeks. Tumor bed boost is necessary with 10Gy in 5 fractions in one week.
Interventions
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axillary radiotherapy
Whole breast irradiation and axillary level I-II areas radiotherapy. The prescription dose is 50Gy in 25 fractions in 5 weeks. Tumor bed boost is necessary with 10Gy in 5 fractions in one week.
Eligibility Criteria
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Inclusion Criteria
* 18\~70 years old
* Pathologically confirmed invasive breast cancer
* A clinical T1-2N0M0 tumor
* Treated with breast conserving surgery and sentinel lymph node biopsy
* 1\~2 positive sentinel lymph nodes, including micro-metastases or macro-metastases.
* ECOG score 1\~2
* Written informed consent
Exclusion Criteria
* Patients underwent mastectomy
* Patients underwent neoadjuvant therapy
* Clinically node positive pre-operative
* Sentinel lymph nodes only containing isolated tumour cells (\<0.2 mm)
* Prior history of invasive breast cancer or previous or concurrent other malignancies within the past 5 years
* Previous radiation therapy of breast or thorax
* Medical contraindication for radiotherapy
* Prior axillary surgery or radiotherapy
* Unable or unwilling to receive breast conserving surgery or sentinel lymph node biopsy
* Pregnant or nursing
18 Years
70 Years
FEMALE
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Xiaoli Yu
Professor of department of radiation oncology
Principal Investigators
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Xiaoli Yu, MD.PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Shanghai Cancer Center
Shanghai, , 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-BC002
Identifier Type: -
Identifier Source: org_study_id