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TRENDY 多中心肝癌随机临床试验 - 试验质量保证包括自动化治疗计划和基准病例结果。

The TRENDY multi-center randomized trial on hepatocellular carcinoma - Trial QA including automated treatment planning and benchmark-case results.

机构信息

Erasmus MC Cancer Institute, Radiotherapy, Rotterdam, The Netherlands.

Erasmus MC Cancer Institute, Radiotherapy, Rotterdam, The Netherlands.

出版信息

Radiother Oncol. 2017 Dec;125(3):507-513. doi: 10.1016/j.radonc.2017.09.007. Epub 2017 Oct 16.

Abstract

BACKGROUND AND PURPOSE

The TRENDY trial is an international multi-center phase-II study, randomizing hepatocellular carcinoma (HCC) patients between transarterial chemoembolization (TACE) and stereotactic body radiation therapy (SBRT) with a target dose of 48-54 Gy in six fractions. The radiotherapy quality assurance (QA) program, including prospective plan feedback based on automated treatment planning, is described and results are reported.

MATERIALS AND METHODS

Scans of a single patient were used as a benchmark case. Contours submitted by nine participating centers were compared with reference contours. The subsequent planning round was based on a single set of contours. A total of 20 plans from participating centers, including 12 from the benchmark case, 5 from a clinical pilot and 3 from the first study patients, were compared to automatically generated VMAT plans.

RESULTS

For the submitted liver contours, Dice Similarity Coefficients (DSC) with the reference delineation ranged from 0.925 to 0.954. For the GTV, the DSC varied between 0.721 and 0.876. For the 12 plans on the benchmark case, healthy liver normal-tissue complication probabilities (NTCPs) ranged from 0.2% to 22.2% with little correlation between NCTP and PTV-D95% (R < 0.3). Four protocol deviations were detected in the set of 20 treatment plans. Comparison with co-planar autoVMAT QA plans revealed these were due to too high target dose and suboptimal planning. Overall, autoVMAT resulted in an average liver NTCP reduction of 2.2 percent point (range: 16.2 percent point to -1.8 percent point, p = 0.03), and lower doses to the healthy liver (p < 0.01) and gastrointestinal organs at risk (p < 0.001).

CONCLUSIONS

Delineation variation resulted in feedback to participating centers. Automated treatment planning can play an important role in clinical trials for prospective plan QA as suboptimal plans were detected.

摘要

背景与目的

TRENDY 试验是一项国际性多中心 II 期研究,将肝细胞癌(HCC)患者随机分为经动脉化疗栓塞(TACE)和立体定向体部放射治疗(SBRT)组,靶剂量为 48-54Gy,分 6 次给予。描述了放射治疗质量保证(QA)计划,包括基于自动治疗计划的前瞻性计划反馈,并报告了结果。

材料与方法

采用单个患者的扫描作为基准病例。比较了 9 个参与中心提交的轮廓与参考轮廓。随后的规划回合基于一组轮廓。对来自 9 个参与中心的 20 个计划,包括 12 个基准病例、5 个临床试点和 3 个首例患者的计划,与自动生成的 VMAT 计划进行了比较。

结果

对于提交的肝脏轮廓,与参考勾画的 Dice 相似系数(DSC)范围为 0.925-0.954。对于 GTV,DSC 介于 0.721-0.876 之间。对于基准病例的 12 个计划,健康肝脏正常组织并发症概率(NTCP)范围为 0.2%-22.2%,与 PTV-D95%(R<0.3)之间几乎没有相关性。在 20 个治疗计划中发现了 4 个方案偏差。与共面自动 VMAT QA 计划的比较表明,这些偏差是由于靶剂量过高和规划不合理所致。总体而言,自动 VMAT 导致平均肝脏 NTCP 降低 2.2 个百分点(范围:16.2 个百分点至-1.8 个百分点,p=0.03),并降低了健康肝脏(p<0.01)和胃肠道危险器官(p<0.001)的剂量。

结论

勾画的差异导致向参与中心提供反馈。自动治疗计划可以在临床试验中发挥重要作用,用于前瞻性计划 QA,因为可以检测到不理想的计划。

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