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Background: TomoBreast is a unicenter, non-blinded randomized trial comparing conventional radiotherapy (CR) vs. hypofractionated Tomotherapy (TT) for post-operative treatment of breast cancer. The purpose of the trial is to compare whether TT can reduce heart and pulmonary toxicity. We evaluate early toxicities., Methods: The trial started inclusion in May 2007 and reached its recruitment in August 2011. Women with stage T1-3N0M0 or T1-2N1M0 breast cancer completely resected by tumorectomy (BCS) or by mastectomy (MA) who consented to participate were randomized, according to a prescribed computer-generated randomization schedule, between control arm of CR 25x2 Gy/5 weeks by tangential fields on breast/chest wall, plus supraclavicular-axillary field if node-positive, and sequential boost 8x2 Gy/2 weeks if BCS (cumulative dose 66 Gy/7 weeks), versus experimental TT arm of 15x2.8 Gy/3 weeks, including nodal areas if node-positive and simultaneous integrated boost of 0.6 Gy if BCS (cumulative dose 51 Gy/3 weeks). Outcomes evaluated were the pulmonary and heart function. Comparison of proportions used one-sided Fisher's exact test., Results: By May 2010, 70 patients were randomized and had more than 1 year of follow-up. Out of 69 evaluable cases, 32 were assigned to CR (21 BCS, 11 MA), 37 to TT (20 BCS, 17 MA). Skin toxicity of grade ≥1 at 2 years was 60% in CR, vs. 30% in TT arm. Heart function showed no significant difference for left ventricular ejection fraction at 2 years, CR 4.8% vs. TT 4.6%. Pulmonary function tests at 2 years showed grade ≥1 decline of FEV1 in 21% of CR, vs. 15% of TT and decline of DLco in 29% of CR, vs. 7% of TT (P = 0.05)., Conclusions: There were no unexpected severe toxicities. Short course radiotherapy of the breast with simultaneous integrated boost over 3 weeks proved feasible without excess toxicities. Pulmonary tests showed a slight trend in favor of Tomotherapy, which will need confirmation with longer follow-up of patients., Trial Registration: [corrected] ClinicalTrials.gov NCT00459628.

As mechanical stability of radiation therapy treatment devices has gone beyond sub-millimeter levels, there is a rising demand for simple yet highly accurate measurement techniques to support the routine quality control of these devices. A combination of using high-resolution radiosensitive film and computer-aided analysis could provide an answer. One generally known technique is the acquisition of star shot films to determine the mechanical stability of rotations of gantries and the therapeutic beam. With computer-aided analysis, mechanical performance can be quantified as a radiation isocenter radius size. In this work, computer-aided analysis of star shot film is further refined by applying an analytical solution for the smallest intersecting circle problem, in contrast to the gradient optimization approaches used until today. An algorithm is presented and subjected to a performance test using two different types of radiosensitive film, the Kodak EDR2 radiographic film and the ISP EBT2 radiochromic film. Artificial star shots with a priori known radiation isocenter size are used to determine the systematic errors introduced by the digitization of the film and the computer analysis. The estimated uncertainty on the isocenter size measurement with the presented technique was 0.04 mm (2σ) and 0.06 mm (2σ) for radiographic and radiochromic films, respectively. As an application of the technique, a study was conducted to compare the mechanical stability of O-ring gantry systems with C-arm-based gantries. In total ten systems of five different institutions were included in this study and star shots were acquired for gantry, collimator, ring, couch rotations and gantry wobble. It was not possible to draw general conclusions about differences in mechanical performance between O-ring and C-arm gantry systems, mainly due to differences in the beam-MLC alignment procedure accuracy. Nevertheless, the best performing O-ring system in this study, a BrainLab/MHI Vero system, and the best performing C-arm system, a Varian Truebeam system, showed comparable mechanical performance: gantry isocenter radius of 0.12 and 0.09 mm, respectively, ring/couch rotation of below 0.10 mm for both systems and a wobble of 0.06 and 0.18 mm, respectively. The methodology described in this work can be used to monitor mechanical performance constancy of high-accuracy treatment devices, with means available in a clinical radiation therapy environment.