title: Adverse event reporting and developments in radiation biology after normal tissue injury: International Atomic Energy Agency consultation.
abstract: OBJECTIVE
  Recent research has enhanced our understanding of radiation injury at the molecular-cellular and tissue levels; significant strides have occurred in standardization of adverse event reporting in clinical trials. In response, the International Atomic Energy Agency, through its Division of Human Health and its section for Applied Radiation Biology and Radiotherapy, organized a consultation meeting in Atlanta (October 2, 2004) to discuss developments in radiobiology, normal tissue reactions, and adverse event reporting.
  
  
  METHODS
  Representatives from cooperative groups of African Radiation Oncology Group, Curriculo Radioterapeutica Ibero Latino Americana, European Organization for Research and Treatment of Cancer, National Cancer Institute of Canada Clinical Trials Group, Radiation Therapy Oncology Group, and Trans-Tasman Radiation Oncology Group held the meeting discussion.
  
  
  RESULTS
  Representatives of major radiotherapy groups/organizations and prominent leaders in radiotherapy discussed current understanding of normal tissue radiobiologic effects, the design and implementation of future clinical and translational projects for normal tissue injury, and the standardization of adverse-event reporting worldwide.
  
  
  CONCLUSIONS
  The consensus was to adopt NCI comprehensive adverse event reporting terminology and grading system (CTCAE v3.0) as the new standard for all cooperative group trials. Future plans included the implementation of coordinated research projects focusing on normal tissue biomarkers and data collection methods.
authors.affiliation: Department of Radiation Oncology, James P. Wilmot Cancer Center, University of Rochester School of Medicine and Dentistry, Rochester, NY 14642-8647, USA. Yuhchyau_chen@urmc.rochester.edu
authors.forename: Yuhchyau
authors.initials: Y
authors.lastname: Chen
authors.forename: Andy
authors.initials: A
authors.lastname: Trotti
authors.forename: C Norman
authors.initials: CN
authors.lastname: Coleman
authors.forename: Mitchell
authors.initials: M
authors.lastname: Machtay
authors.forename: Rene O
authors.initials: RO
authors.lastname: Mirimanoff
authors.forename: John
authors.initials: J
authors.lastname: Hay
authors.forename: Peter C
authors.initials: PC
authors.lastname: O'brien
authors.forename: Brahim
authors.initials: B
authors.lastname: El-Gueddari
authors.forename: Joao V
authors.initials: JV
authors.lastname: Salvajoli
authors.forename: Branislav
authors.initials: B
authors.lastname: Jeremic
mesh_terms: D015415:Biomarkers / Q000032:analysis; D004249:DNA Damage; D004014:Dictionaries as Topic; D006801:Humans; D007390:International Agencies / Q000592:standards*; D009369:Neoplasms / Q000532:radiotherapy*; D009678:Nuclear Energy; D011183:Postoperative Complications; D011832:Radiation Injuries / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control; D018787:Radiation Oncology / Q000458:organization & administration / Q000592:standards; D011837:Radiation-Protective Agents / Q000627:therapeutic use; D011853:Radiobiology / Q000592:standards*; D011879:Radiotherapy Dosage; D012720:Severity of Illness Index; D009626:Terminology as Topic
chemical_list: D015415:Biomarkers; D011837:Radiation-Protective Agents