Hypofractionation with simultaneous integrated boost has been investigated in a few trials and appears to be safe and feasible with less lung toxicity in smaller studies. Investigators initiated this multicenter phase II prospective trial to analyse acute toxicity of hypofractionation with simultaneous integrated boost in patients with early breast cancer under the hypothesis that the ratio of patients with acute radiogenic toxicity Grad II according NCI-CTCAE amounts maximum 20%.
Hypofractionated radiotherapy of the breast 16 × 2.50 Gy with simultaneous integrated boost to the tumor bed (total dose within the boost volume 16 × 3.00 Gy).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Charité University Medical Center Berlin
Berlin, Germany
Krankenhaus Buchholz
Buchholz, Germany
Acute Skin Toxicity
Acute skin radiogenic toxicity grade II or higher according to NCI-CTCAE
Time frame: 6 months
Number of Patients treated on Protocol
Dose constraints Dmedian lung \< 10 Gy; Dmedian heart \< 5 Gy, Dmax ≤ 40 Gy; Dmedian anterior branch of the left coronary artery (LAD, RIVA) \< 15 Gy, Dmax ≤ 40 Gy; Dmedian contralateral breast \< 3 Gy
Time frame: 22-29 days (16 fractions)
Acute General Toxicity
All dimensions of NCI-CTCAE
Time frame: 0 to 6 months
Quality of life Score
EORTC QLQ-C30, -BR23
Time frame: 0 to 6 months
Performance
ECOG
Time frame: 0 to 6 months
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