C50.9
Conditions
Interventions
Group 1: 10 x 3.80 Gy up to 38 Gy (ICRU-50 reference point). 1 or 2 daily fractions of 3.80 Gy, with a daily break of at least 6 hours in between. Treatment is applied in 5-10 consecutive working days
Sponsors
Universitätsklinikum ErlangenStrahlenklinik
Eligibility
Sex/Gender
Female
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: Histologically confirmed breast cancer or ductal carcinoma in situ (DCIS) pT1-2 breast cancer = 3 cm Complete resection (R0) No or microscopic axillary involvement (pN0 or pN0sn, pN1mi). No distant metastases (M0) No contralateral breast cancer/DCIS Karnofsky-Index = 60%. Age = 50 years. Hormonal sensitive tumors (ER+/PR+; ER+/PR-; ER-/PR+). Safety margin = 5 mm for invasive-lobular cancer and DCIS, for al others = 2mm. Tumor bed clips. Written informed consent.
Exclusion criteria
Exclusion criteria: All patients who do not fit inclusion criteria. Multicentric groth pattern. Diffuse microcalcifications. Extensive intraductal component (EIC). Peritumoral vessel involvement (L1, V1) Unclear margins Anthracyclin-based chemotherapy. Morbus Paget or pathological skin infiltration. Synchrone or past breast cancer in the history. Earlier malignancy within 5 years before study recruitment with exception of non-melanoma skin cancer or cervical cancer FIGO I. Pregnant or lactating women. Soft tissue disease. Genetic predisposition for increased radiosensitivity, e.g. Ataxia telangiectatica or comparable. Psychiatric disorders decreased compliance. Patients in which APBI is technically not practicable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Locoregional tumor control will be determined clinically and mammographically as well as with ultrasound examination every 6 months during the first five years of follow-up, and every 12 months in the years 6 to 10. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of side effects by clinical examination every 6 months during years 1-5 and every 12 months during years 6-10 of follow-up. Cosmetic outcome by clinical examination and unsing the Harvard scale every 6 months during years 1-5 and every 12 months during years 6-10 of follow-up. Quality of life (QoL) by using EORTC-questionnaires (QLQ C-30 and BR-23) every 6 months during years 1-5 and every 12 months during years 6-10 of follow-up. Local-recurrence-free survival using clinical examination, mammograms and ultrasound of the involved breast every 6 months during years 1-5 and every 12 months during years 6-10 of follow-up. Disease-free survival using clinical examination, mammograms and ultrasound of the involved breast every 6 months during years 1-5 and every 12 months during years 6-10 of follow-up. Overall survival using clinical examination every 6 months during years 1-5 and every 12 months during years 6-10 of follow-up. | — |
Countries
Germany
Contacts
Public ContactOliver Ott
Universitätsklinikum ErlangenStrahlenklinik
Outcome results
None listed