Perez C A, Gardner P, Glasgow G P
Int J Radiat Oncol Biol Phys. 1984 Jun;10 Suppl 1:119-25. doi: 10.1016/0360-3016(84)90460-7.
The goal of radiation therapy is to yield the greatest possible uncomplicated local and regional tumor control. An acceptable quality of life with few severe complications, anatomical defects or psychological disturbances should be an integral objective of excellent radiation therapy. Inasmuch as higher doses of irradiation and adequacy of treatment portals (volume irradiated) appear to correlate with greater probability of tumor control and major complications, there is a critical need to optimize treatment planning and quality assurance in radiation therapy. Along with this, techniques must be developed for reliable patient reposition and immobilization so that the optimized treatment plan can be translated into precise delivery of the irradiation. It is obvious that in clinical trials the basic parameters of therapy need to be optimally observed, in order to make comparison of experimental arms more reliable. It is easier to achieve uniformity of technical factors in a study at a single institution than in multi-institutional cooperative groups. Thus, stringent criteria must be incorporated into the protocol describing the requirements and techniques for planning and delivery of the radiation therapy. Furthermore, the dosimetry checks carried out by the Radiological Physics Center should be an integral part of this program. In some studies it is necessary to do an initial review of dosimetry factors and portal films. This alerts the radiation oncologist to variations from the protocol and, with prompt feedback and correction of the potential error, will ensure the complete evaluability of the case. Since an increasing number of reports point out that the doses of irradiation delivered and the volume treated may affect therapeutic results, a completed case review should always be carried out. Some cooperative group studies strongly suggest a correlation between the compliance with the protocol and the results of the trial. Costs of these programs in clinical trials should be justified since, for a small investment, the evaluability rate in a protocol can be increased by 10%. The increase of patient evaluability significantly decreases the cost per evaluable patient. Furthermore, the reliability of the data of the trial will be greatly enhanced by a strong quality assurance program.
放射治疗的目标是尽可能实现局部和区域肿瘤的无并发症控制。具备可接受的生活质量，且严重并发症、解剖缺陷或心理障碍较少，应是优质放射治疗的一个重要目标。鉴于更高的照射剂量和治疗野（照射体积）的充足性似乎与肿瘤控制和主要并发症的发生概率更高相关，因此迫切需要优化放射治疗的治疗计划和质量保证。与此同时，必须开发可靠的患者重新定位和固定技术，以便将优化后的治疗计划转化为精确的照射实施。显然，在临床试验中，需要最佳地观察治疗的基本参数，以使实验组之间的比较更可靠。在单一机构进行的研究中比在多机构合作组中更容易实现技术因素的一致性。因此，必须将严格的标准纳入描述放射治疗计划和实施的要求及技术的方案中。此外，由放射物理中心进行的剂量学检查应是该计划的一个组成部分。在一些研究中，有必要对剂量学因素和射野片进行初步审查。这会提醒放射肿瘤学家注意与方案的差异，并通过及时反馈和纠正潜在误差，确保病例的完全可评估性。由于越来越多的报告指出所给予的照射剂量和治疗体积可能影响治疗结果，因此应始终进行完整的病例审查。一些合作组研究强烈表明方案的依从性与试验结果之间存在相关性。临床试验中这些方案的成本应是合理的，因为只需少量投资，方案中的可评估率就能提高10%。患者可评估性的提高显著降低了每个可评估患者的成本。此外，强大的质量保证计划将大大提高试验数据的可靠性。
