Journal
EUROPEAN JOURNAL OF CANCER
Volume 39, Issue 14, Pages 2035-2042Publisher
ELSEVIER SCI LTD
DOI: 10.1016/S0959-8049(03)00455-6
Keywords
randomised clinical trial; individual case review; quality assurance; breast cancer; radiotherapy; internal mammary chain
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To assess consistency among participants in an European Organisation for Research and Treatment of Cancer (EORTC) phase III trial randomising between irradiation and no irradiation of the internal mammary and medial supraclavicular (IM-MS) lymph nodes, all participating institutes were invited to send data from 3 patients in each arm as soon as they started accrual. The evaluation focused on eligibility, compliance with the radiotherapy guidelines, treatment techniques and dose prescription to the IM-MS region. Nineteen radiotherapy departments provided a total of I I I cases, all being eligible. Minor discrepancies were found in the surgery and pathology data in almost half the patients. Major radiotherapy protocol deviations were very limited: 2 cases of unwarranted irradiation of the supraclavicular region and a significant dose deviation to the internal mammary region in 5 patients. The most frequently observed minor protocol deviation was the absence of delineation of the target volumes in 80% of the patients. By detecting systematic protocol deviations in an early phase of the trial, recommendations made to all the participating institutes should improve the interinstitutional consistency and promote a high-quality treatment. (C) 2003 Elsevier Ltd. All rights reserved.
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