A prospective Phase III trial evaluating patient self‐reported pain and cosmesis in accelerated partial breast irradiation utilizing 3‐D versus intensity‐modulated radiotherapy

Purpose/Objective The primary objective is to examine patient self‐assessment of breast pain and cosmesis between three‐dimensional (3D‐CRT) versus intensity‐modulated radiotherapy (IMRT). The secondary objective is to evaluate any relationship of treatment planning conformality of both cohorts to patient‐assessed pain. Assessments were performed at interim 12, 24, 36, and 48 months with a final 5‐year assessment. Materials/Methods In total, 656 patients (3D‐CRT n = 328; IMRT n = 328) were randomly assigned to either IMRT or 3D‐CRT accelerated partial breast radiotherapy to 38.5 Gy in 10 BID 3.85 Gy fractions. Results Median follow‐up was 3 years. Multivariate analysis showed that pain severity significantly decreased from baseline to the 12‐month follow‐up visit (