APBI Versus EBRT Therapy After Breast Conserving Surgery for Low-risk Breast Cancer
NCT00402519 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1300
Last updated 2016-05-13
Summary
To assess the role of interstitial brachytherapy alone compared to whole breast irradiation in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure (all ipsilateral local recurrences) to affirm the hypothesis that local control rates in each arm are equivalent.
Conditions
Interventions
- RADIATION
-
Accelerated partial breast irradiation
APBI with PDR and HDR brachytherapy
- RADIATION
-
External beam whole breast irradiation
Standard Whole breast irradiation
Sponsors & Collaborators
-
University of Erlangen-Nürnberg Medical School
lead OTHER
Principal Investigators
-
Vratislav Strnad, MD · University Hospital Erlangen, Germany
-
Csaba Polgár, MD · National Institute of Oncology Budapest, Hungary
-
Oliver J Ott, MD · University Hospital Erlangen, Germany
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-11-30
- Primary Completion
- 2009-11-30
- Completion
- 2019-11-30
Countries
- Austria
- Germany
- Hungary
- Poland
- Spain
Study Locations
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