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≤5厘米肝细胞癌立体定向消融放疗多中心II期研究的质量保证:一次计划预演。

Quality assurance for a multicenter Phase II study of stereotactic ablative radiotherapy for hepatocellular carcinoma ≤5 cm: a planning dummy run.

作者信息

Bae Sun Hyun, Kim Mi-Sook, Jang Won Il, Kim Kum Bae, Cho Kwang Hwan, Kim Woo Chul, Lee Chang Yeol, Kim Eun Seog, Choi Chul Won, Chang A Ram, Jo Sunmi, Kim Jin-Young

机构信息

Department of Radiation Oncology, Soonchunhyang University College of Medicine, Bucheon.

Department of Radiation Oncology, Korea Institute of Radiological & Medical Sciences, Seoul.

出版信息

Jpn J Clin Oncol. 2017 Jun 1;47(6):535-542. doi: 10.1093/jjco/hyw156.

Abstract

OBJECTIVE

The Korean Radiation Oncology Group (12-02) investigated the outcome of stereotactic ablative radiotherapy for hepatocellular carcinoma ≤5 cm using 60 Gy in three fractions. To evaluate dosimetric differences and compliance in a multicenter trial, a planning dummy run procedure was performed.

METHODS

All six participating institutions were provided the contours of two dummy run cases. Plans were performed following the study protocol to cover the planning target volume with a minimum of 90% of the prescription dose and to satisfy the constraints for organs at risk. We assessed the institutional variations in plans using dose-volume histograms.

RESULTS

Different planning techniques were applied: static intensity-modulated radiotherapy in two institutions, CyberKnife in two institutions and RapidArc in two institutions. The conformity index of all 12 plans was ≤1.2. In terms of the planning target volume coverage, all participants followed our study protocol. For the second dummy run case, located in Segment 8 near the heart, the minimum dose of the planning target volume (D99%: dose covering 99% of the planning target volume) was variable because there was no mention of constraints of D99% of the planning target volume in the study protocol. As an important organ at risk, the normal liver volumes receiving <17 Gy in all 12 plans were >700 ml.

CONCLUSIONS

Dosimetric parameters showed acceptable compliance with the study protocol. However, we found the possibility of underdose to the planning target volume if the hepatocellular carcinoma lesion was located near organs at risk such as the heart. Based on this dummy run, we will conduct individual case reviews to minimize the effects of study protocol deviation.

摘要

目的

韩国放射肿瘤学组(12 - 02)研究了采用60 Gy分三次照射对直径≤5 cm的肝细胞癌进行立体定向消融放疗的疗效。为了在多中心试验中评估剂量差异和依从性,进行了一次计划模拟运行程序。

方法

向所有六个参与机构提供了两个模拟运行病例的轮廓。按照研究方案进行计划,以至少90%的处方剂量覆盖计划靶体积,并满足危及器官的限制条件。我们使用剂量体积直方图评估各机构计划的差异。

结果

应用了不同的计划技术:两个机构采用静态调强放疗,两个机构采用射波刀,两个机构采用容积旋转调强放疗。所有12个计划的适形指数均≤1.2。在计划靶体积覆盖方面,所有参与者均遵循我们的研究方案。对于位于心脏附近的第8段的第二个模拟运行病例,计划靶体积的最小剂量(D99%:覆盖99%计划靶体积的剂量)存在差异,因为研究方案中未提及计划靶体积D99%的限制条件。作为一个重要的危及器官,所有12个计划中接受<17 Gy照射的正常肝脏体积均>700 ml。

结论

剂量学参数显示对研究方案的依从性可接受。然而,我们发现,如果肝细胞癌病变位于心脏等危及器官附近,计划靶体积可能存在剂量不足的情况。基于这次模拟运行,我们将进行个案审查,以尽量减少研究方案偏差的影响。

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