C50
Conditions
Interventions
Group 1: normofractionated radiotherapy (2 Gy per fraction, 25 fractions, duration 5 weeks, total dose 50 Gy (whole breast)
in addition in invasive carcinomas boost with a total of 10 Gy in 5 fractions)
Group 2: hypofractionated radiotherapy (2.67 Gy per fraction, 15 fractions, duration 4 weeks, total dose 40.05 Gy (whole
in addition in invasive carcinomas boost with a total of 10 Gy in 5 fractions)
Sponsors
Universitätsklinikum DresdenKlinik für Strahlentherapie und Radioonkologie
Eligibility
Sex/Gender
Female
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: - Women> 40 years (on the day of surgery her breast cancer) - Status after breast-conserving surgery, R0 with a sufficient safety distance in accordance with applicable S3 guideline - tumor stage pT1-2, pN0 N1mi, M0 or ductal carcinoma in situ of the breast with an indication for radiotherapy - status after sentinel node biopsy or axillary dissection - indication for radiotherapy of the breast - patient is able to attend regular follow-ups
Exclusion criteria
Exclusion criteria: - indication for radiotherapy of the regional lymphatic drainage according S3 guideline - previous breast cancer or DCIS - bilateral breast cancer - previous radiotherapy of the breast or thorax - breast implants (regardless of side) - pregnant or lactating women - comorbidities that might increase the radiosensitivity, particularly dermatomyositis, systemic lupus erythematosus or scleroderma, symptomatic cardiac or pulmonary disease, puncture needy seroma of the breast, existing breast infection - conditions that prevent the patient at the completion of radiotherapy or in participating in the follow-ups
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| chronic toxicity (fibrosis of the breast -> stage 2; 3 years after radiation therapy; analysis by scoring (CTC-AE v4)) | — |
Secondary
| Measure | Time frame |
|---|---|
| - local tumor control (mammography, sonography in each case after 3 years) - acute toxicity (3 years after radiation therapy; chronic toxicity of the skin > stage 2 (scoring CTCAE v4), cosmetic result (foto and self-assesment), quality of life (questionnaire)) | — |
Countries
Germany
Contacts
Public ContactMechthild Krause
Universitätsklinikum DresdenKlinik für Strahlentherapie und Radioonkologie
Outcome results
None listed