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Lungtech,一项关于立体定向体部放疗(SBRT)用于中央型肺肿瘤的欧洲癌症研究与治疗组织(EORTC)II期试验——临床物理学视角

Lungtech, a phase II EORTC trial of SBRT for centrally located lung tumours - a clinical physics perspective.

作者信息

Lambrecht Marie, Melidis Christos, Sonke Jan-Jakob, Adebahr Sonja, Boellaard Ronald, Verheij Marcel, Guckenberger Matthias, Nestle Ursula, Hurkmans Coen

机构信息

Department of Radiation Oncology, Catharina Hospital, Eindhoven, The Netherlands.

EORTC Headquarters, Brussels, Belgium.

出版信息

Radiat Oncol. 2016 Jan 20;11:7. doi: 10.1186/s13014-015-0567-5.

Abstract

BACKGROUND

The EORTC has launched a phase II trial to assess safety and efficacy of SBRT for centrally located NSCLC: The EORTC 22113-08113-Lungtech trial. Due to neighbouring critical structures, these tumours remain challenging to treat. To guarantee accordance to protocol and treatment safety, an RTQA procedure has been implemented within the frame of the EORTC RTQA levels. These levels are here expanded to include innovative tools beyond protocol compliance verification: the actual dose delivered to each patient will be estimated and linked to trial outcomes to enable better understanding of dose related response and toxicity.

METHOD

For trial participation, institutions must provide a completed facility questionnaire and beam output audit results. To insure ability to comply with protocol specifications a benchmark case is sent to all centres. After approval, institutions are allowed to recruit patients. Nonetheless, each treatment plan will be prospectively reviewed insuring trial compliance consistency over time. As new features, patient's CBCT images and applied positioning corrections will be saved for dose recalculation on patient's daily geometry. To assess RTQA along the treatment chain, institutions will be visited once during the time of the trial. Over the course of this visit, end-to-end tests will be performed using the 008ACIRS-breathing platform with two separate bodies. The first body carries EBT3 films and an ionization chamber. The other body newly developed for PET- CT evaluation is fillable with a solution of high activity. 3D or 4D PET-CT and 4D-CT scanning techniques will be evaluated to assess the impact of motion artefacts on target volume accuracy. Finally, a dosimetric evaluation in static and dynamic conditions will be performed.

DISCUSSION

Previous data on mediastinal toxicity are scarce and source of cautiousness for setting-up SBRT treatments for centrally located NSCLC. Thanks to the combination of documented patient related outcomes and CBCT based dose recalculation we expect to provide improved models for dose response and dose related toxicity.

CONCLUSION

We have developed a comprehensive RTQA model for trials involving modern radiotherapy. These procedures could also serve as examples of extended RTQA for future radiotherapy trials involving quantitative use of PET and tumour motion.

摘要

背景

欧洲癌症研究与治疗组织(EORTC)开展了一项II期试验,以评估立体定向体部放疗(SBRT)治疗中央型非小细胞肺癌(NSCLC)的安全性和有效性:EORTC 22113 - 08113 - Lungtech试验。由于邻近关键结构,这些肿瘤的治疗仍然具有挑战性。为确保符合方案要求并保证治疗安全,在EORTC放疗质量保证(RTQA)水平框架内实施了RTQA程序。这些水平在此扩展,以纳入超出方案合规性验证的创新工具:将估算每个患者实际接受的剂量,并将其与试验结果相关联,以便更好地理解剂量相关反应和毒性。

方法

对于参与试验的机构,必须提供完整的设备问卷和射束输出审核结果。为确保有能力符合方案规范,向所有中心发送一个基准病例。批准后,机构方可招募患者。尽管如此,每个治疗计划都将进行前瞻性审查,以确保随时间推移试验合规的一致性。作为新的特点,患者的CBCT图像和应用的定位校正将被保存,以便根据患者每日的几何形状进行剂量重新计算。为评估整个治疗链的RTQA,在试验期间将对机构进行一次访视。在这次访视过程中,将使用008ACIRS呼吸平台和两个独立的体模进行端到端测试。第一个体模装有EBT3胶片和一个电离室。为PET - CT评估新开发的另一个体模可填充高活度溶液。将评估3D或4D PET - CT以及4D - CT扫描技术,以评估运动伪影对靶区体积准确性的影响。最后,将在静态和动态条件下进行剂量学评估。

讨论

关于纵隔毒性的既往数据稀缺,这是为中央型NSCLC设置SBRT治疗时谨慎的原因。由于记录的患者相关结果与基于CBCT的剂量重新计算相结合,我们期望能提供改进的剂量反应和剂量相关毒性模型。

结论

我们为涉及现代放疗的试验开发了一个全面的RTQA模型。这些程序也可作为未来涉及PET定量使用和肿瘤运动的放疗试验扩展RTQA的范例。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8a40/4721147/1107614f19a8/13014_2015_567_Fig1_HTML.jpg

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