van Tienhoven G, Mijnheer B J, Bartelink H, González D G
Academic Medical Centre, Amsterdam, The Netherlands.
Strahlenther Onkol. 1997 Apr;173(4):201-7. doi: 10.1007/BF03039289.
The initial quality assurance programme of the EORTC Radiotherapy Cooperative Group in trial 22881/10882 is described. The implications of its results for quality assurance in future trials are discussed.
In the EORTC trial 22881/10882 patients with stage I or II breast cancer are treated with tumor excision, axillary dissection, 50 Gy whole breast irradiation and then randomized to receive a boost dose of 15 Gy or no boost following complete tumor excision or between 10 Gy or 25 Gy in case of incomplete excision. To avoid or diminish protocol deviations and to quantify inevitable variations an extensive initial quality assurance programme was conducted. The programme consisted of a dummy run procedure an individual case review procedure, in vivo dosimetry studies and phantom dosimetry studies.
This combination of quality assurance procedures allows a good estimation of patient to patient and inter-institutional variations, and early detection of (potential) systematic protocol deviations of 3 types: 1. Deviations due to ambiguities in the protocol prescriptions. 2. Deviations not known to the institution, such as mistakes in implementation of treatment planning algorithms resulting in a systematic overdosage or underdosage. 3. Inability of an institution to cope with (precise) protocol prescriptions for technical or logistic reasons.
The first 2 types of deviations may be corrected or avoided by direct discussions and recommendations. With respect to the third type it is up to the trial coordinator to accept participation or not, depending upon the relative importance of the particular deviation(s) for the trial end points. To be effective, such a quality assurance programme must be implemented as early as possible in the course of a clinical trial.
描述了欧洲癌症研究与治疗组织（EORTC）放射治疗协作组在试验22881/10882中的初始质量保证计划。讨论了其结果对未来试验质量保证的影响。
在EORTC试验22881/10882中，I期或II期乳腺癌患者接受肿瘤切除、腋窝清扫、全乳50 Gy照射，然后随机分为两组，肿瘤完全切除后接受15 Gy的追加剂量或不追加，若切除不完全则接受10 Gy或25 Gy的追加剂量。为避免或减少方案偏差并量化不可避免的变异，开展了广泛的初始质量保证计划。该计划包括模拟运行程序、个案审查程序、体内剂量测定研究和体模剂量测定研究。
这种质量保证程序的组合能够很好地估计患者之间和机构之间的变异，并早期检测出3种类型的（潜在）系统性方案偏差：1. 由于方案处方不明确导致的偏差。2. 机构未知的偏差，如治疗计划算法实施中的错误导致系统性过量或剂量不足。3. 机构由于技术或后勤原因无法遵守（精确的）方案处方。
前两种类型的偏差可通过直接讨论和建议进行纠正或避免。对于第三种类型，试验协调员应根据特定偏差对试验终点的相对重要性决定是否接受该机构参与。要有效，这样的质量保证计划必须在临床试验过程中尽早实施。
