title: Quality assurance for prospective EORTC radiation oncology trials: the challenges of advanced technology in a multicenter international setting.
abstract: The European Organization for the Research and Treatment of Cancer (EORTC) is a pan-European structure charged with improving cancer treatment through the testing of new therapeutic strategies in phases I-III clinical studies. Properly conducted trials in radiation oncology are required to demonstrate superiority of a new treatment over the current standard. The Radiation Oncology Group (ROG) has initiated a complex quality assurance (QA) program to ensure safe and effective treatment delivery. Most modern trials are multicenter and multidisciplinary, further increasing the importance of early, strict and consistent QA in radiotherapy (RT). QART measures confirm whether a site possesses minimum staff and equipment for participation. Dummy runs, reviews of patient treatment plans and complex dosimetry checks verify the ability of an institution to comply with the protocol. Data required for evaluation are increasingly exchanged digitally, allowing detailed plan reconstruction, evaluation of target volume delineation and recalculation of dose-volume parameters for comparison against predefined standards. The five tiers of QA implemented in EORTC trials are reviewed, along with past, current and future QART initiatives. As substantial human and financial resources are increasingly invested in QART, the importance of cost-benefit analysis of QA and its impact on clinical outcome cannot be overstated.
authors: Geneva University Hospital, Switzerland.
authors: Damien C
authors: DC
authors: Weber
authors: Philip M P
authors: PM
authors: Poortmans
authors: Coen W
authors: CW
authors: Hurkmans
authors: Edwin
authors: E
authors: Aird
authors: Akos
authors: A
authors: Gulyban
authors: Alysa
authors: A
authors: Fairchild
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D005060:Europe; D006801:Humans; D015337:Multicenter Studies as Topic; D009369:Neoplasms / Q000532:radiotherapy*; D011446:Prospective Studies; D011785:Quality Assurance, Health Care / Q000191:economics; D011879:Radiotherapy Dosage; D050397:Radiotherapy, Intensity-Modulated / Q000592:standards