Matzinger Oscar, Poortmans Philip, Giraud Jean-Yves, Maingon Philippe, Budiharto Tom, van den Bergh Alfons C M, Davis J Bernard, Musat Elena, Ataman Fatma, Huyskens Dominique P, Gulyban Akos, Bolla Michel
EORTC Headquarters, Belgium.
Radiother Oncol. 2009 Mar;90(3):285-90. doi: 10.1016/j.radonc.2008.10.022. Epub 2008 Nov 27.
EORTC trial 22991 was designed to evaluate the addition of concomitant and adjuvant short-term hormonal treatments to curative radiotherapy in terms of disease-free survival for patients with intermediate risk localized prostate cancer. In order to assess the compliance to the 3D conformal radiotherapy protocol guidelines, all participating centres were requested to participate in a dummy run procedure. An individual case review was performed for the largest recruiting centres as well.
CT-data of an eligible prostate cancer patient were sent to 30 centres including a description of the clinical case. The investigator was requested to delineate the volumes of interest and to perform treatment planning according to the protocol. Thereafter, the investigators of the 12 most actively recruiting centres were requested to provide data on five randomly selected patients for an individual case review.
Volume delineation varied significantly between investigators. Dose constraints for organs at risk (rectum, bladder, hips) were difficult to meet. In the individual case review, no major protocol deviations were observed, but a number of dose reporting problems were documented for centres using IMRT.
Overall, results of this quality assurance program were satisfactory. The efficacy of the combination of a dummy run procedure with an individual case review is confirmed in this study, as none of the evaluated patient files harboured a major protocol deviation. Quality assurance remains a very important tool in radiotherapy to increase the reliability of the trial results. Special attention should be given when designing quality assurance programs for more complex irradiation techniques.
欧洲癌症研究与治疗组织（EORTC）试验22991旨在评估在中度风险局限性前列腺癌患者的根治性放疗基础上，加用同步和辅助短期激素治疗对无病生存期的影响。为评估对三维适形放疗方案指南的依从性，要求所有参与中心参加一次模拟运行程序。还对最大的入组中心进行了个案审查。
将一名符合条件的前列腺癌患者的CT数据发送至30个中心，包括临床病例描述。要求研究者勾勒出感兴趣的体积，并根据方案进行治疗计划。此后，要求12个最积极入组的中心的研究者提供5例随机选择患者的数据进行个案审查。
研究者之间的体积勾勒差异显著。危及器官（直肠、膀胱、髋部）的剂量限制难以满足。在个案审查中，未观察到重大方案偏差，但记录了一些使用调强放疗（IMRT）的中心存在剂量报告问题。
总体而言，该质量保证计划的结果令人满意。本研究证实了模拟运行程序与个案审查相结合的有效性，因为评估的患者档案均未存在重大方案偏差。质量保证仍然是放疗中提高试验结果可靠性的非常重要的工具。在为更复杂的照射技术设计质量保证计划时应给予特别关注。
