title: A prospective picture collection study for a grading atlas of radiation dermatitis for clinical trials in head-and-neck cancer patients.
abstract: Radiation dermatitis is one of the most common acute toxicities of both radiotherapy and chemoradiotherapy. Many clinical trials have evaluated the level of toxicity using the Common Terminology Criteria for Adverse Events ver. 4.03. This criterion accounts for severity in a single sentence only, and no visual classification guide has been available. Thus, there is a risk of subjective interpretation by the individual investigator. This contrasts with the situation with hematologic toxicities, which can be interpreted objectively. The aim of this prospective picture collection study was to develop a grading tool for use in establishing the severity of radiation dermatitis in clinical trials. A total of 118 patients who were scheduled to receive definitive or postoperative radiotherapy or chemoradiotherapy were enrolled from the four participating cancer centers. All researchers in our group used the same model of camera under the same shooting conditions to maintain consistent photographic quality. In all, 1600 photographs were collected. Of these, 100 photographs qualified for the first round of selection and were then graded by six experts, basically in accordance with the CTCAE ver. 4.03 (JCOG ver. in Japanese). After further study, 38 photographs were selected as representing typical models for Grade 1-4 radiation dermatitis; the radiation dermatitis grading atlas was produced from these photographs. The atlas will play a major role in ensuring that the dermatitis rating system is consistent between the institutions participating in trials. We hope that this will contribute to improving the quality of clinical trials, and also to improving the level of routine clinical practice.
authors: Department of Radiation Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital szenda@east.ncc.go.jp.
authors: Sadamoto
authors: S
authors: Zenda
authors: Department of radiation Oncology, Hyogo Cancer Center.
authors: Yosuke
authors: Y
authors: Ota
authors: Division of Radiation Oncology, Aichi Cancer Center Hospital.
authors: Hiroyuki
authors: H
authors: Tachibana
authors: Division of Radiation Oncology, Shizuoka Cancer Center Hospital.
authors: Hirofumi
authors: H
authors: Ogawa
authors: Department of Radiation Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan.
authors: Shinobu
authors: S
authors: Ishii
authors: Nursing Hyogo Cancer Center.
authors: Chikako
authors: C
authors: Hashiguchi
authors: Department of Radiation Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan.
authors: Tetsuo
authors: T
authors: Akimoto
authors: Department of Thoracic Oncology, National Cancer Center Hospital.
authors: Yuichiro
authors: Y
authors: Ohe
authors: Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital.
authors: Yosuke
authors: Y
authors: Uchitomi
mesh_terms: D002986:Clinical Trials as Topic; D006258:Head and Neck Neoplasms / Q000532:radiotherapy*; D006801:Humans; D010781:Photography; D011446:Prospective Studies; D011855:Radiodermatitis / Q000209:etiology*
keywords: acute toxicity; grading system; head-and-neck cancer; radiation dermatitis; radiotherapy