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The purpose of this study was to determine the organ specific dose constraints in head and neck carcinoma treated with intensity-modulated radiation therapy (IMRT) using data from a multi-institutional clinical trial (JCOG1015). Dose constraints used in the JCOG1015 were as follows; Spinal cord Dmax <50 Gy, Brain Dmax <70 Gy, Brainstem Dmax <54 Gy, Optic nerve Dmax <50 Gy, Eyeball Dmax <40 Gy, Lens Dmean <6 Gy, Parotid gland Dmean <26 Gy, pharyngeal constrictor muscle (PCM) Dmean <54 Gy, Larynx Dmean <54 Gy, Inner ear Dmean <45 Gy. Brain D1cc, brainstem D1cc, and thyroid Dmean were not stated but recorded. Patient data and dose-volume histograms (DVH) of organs-at-risk (OARs) were collected from 74 patients with nasopharyngeal carcinoma treated with IMRT who enrolled in the JCOG1015 trial. The incidence of late toxicities was evaluated using the cumulative incidence method or prevalence. ROC analysis was used to estimate the optimal DVH cut-off value that predicted toxicities. Estimated DVH cut-off values were brainstem D1cc:55.8 Gy for G1 myelitis, brain D1cc:72.1 Gy for ≥G1 central nerve necrosis, optic nerve Dmax:53.3 Gy for G2 vision impaired, eye-ball Dmax:36.6 Gy for G2 impaired, PCM Dmean:41.2 Gy for ≥G2 dysphagia, ipsilateral inner ear Dmean:44.0 Gy for ≥G2 hearing impaired, ipsilateral inner ear Dmean:51.5 Gy for ≥G2 middle ear inflammation, and thyroid Dmean: 45.6 Gy for G1 hypothyroidism. The 3- and 5-year cumulative incidence of late toxicity by dose metrics were shown in Table 1. The estimated cut-off values were similar to dose constraints criteria used in the JCOG1015 except for PCM. In patients who received higher dose than the dose constraints in brainstem and inner ear, incidence of myelitis and hearing impaired were notably high. The dose constraints criteria of the JCO1015 were appropriate for most OARs, although more strict dose constraints might be necessary for PCM. Dose constraints for inner ear and brainstem should be archived with higher priority. [ABSTRACT FROM AUTHOR]