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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,300
APBI with PDR and HDR brachytherapy
Standard Whole breast irradiation
University Hospital AKH Wien, Department of Radiotherapy and Radiobiology
Vienna, Austria
University Hospital Erlangen, Department of Radiation Oncology
Erlangen, Germany
University Hospital Kiel, Department of Radiation Oncology
Kiel, Germany
Local control
Time frame: 5-years, 10 ten-years
Incidence and severity of acute and late side effects
Time frame: 5-years
Differences in cosmetic results
Time frame: 5-years
Distant metastases free survival
Time frame: 5-years
Survival rates (Overall Survival, Disease-free Survival)
Time frame: 5-years
Contralateral breast cancer rate
Time frame: 5-years
Quality-of-Life
Time frame: 5-years
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University Hospital Leipzig, Department of Radiation Oncology
Leipzig, Germany
University Hospital Lübeck, Department of Radiation Oncology
Lübeck, Germany
Hospital Barmherzige Brüder, Department of Radiation Oncology
Regensburg, Germany
University Hospital Rostock, Department of Radiation Oncology
Rostock, Germany
National Institute of Oncology, Department of Radiation Oncology
Budapest, Hungary
Kierownik Zakladu Brachyterapii, Cetrum Onkologii
Warsaw, Poland
Catalan Institut of Oncology, Department of Radiation Oncology
Barcelona, Spain
...and 1 more locations