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多机构三维放射治疗临床试验质量保证的初步经验。简要报告。

Initial experience with quality assurance of multi-institutional 3D radiotherapy clinical trials. A brief report.

作者信息

Purdy J A, Harms W B, Michalski J, Bosch W R

机构信息

Radiation Oncology Center, Mallinckrodt Institute of Radiology, Washington University School of Medicine, St. Louis, Missouri, USA.

出版信息

Strahlenther Onkol. 1998 Oct;174 Suppl 2:40-2.

PMID:9810337
Abstract

In 1992, a 3D Quality Assurance (3D QA) Center was established at the Mallinckrodt Institute of Radiology under the auspices of the Radiation Therapy Oncology Group (RTOG). The role of the 3D QA Center is to provide quality assurance reviews of external beam treatment planning and verification (TPV) information for patients enrolled in multi-institutional 3D radiotherapy treatment protocols. Computer hardware and software components have been implemented which allow participating institutions to submit (via either the Internet or magnetic tape) common format 3D TPV data for QA review including: volumetric CT image data, normal structure, tumor and target volume contours, digitally reconstructed radiographs or simulator (prescription) and portal radiographs, beam geometry, dose distributions, fractionation information, and dose-volume histograms. Prior to enrolling patients on a 3D radiotherapy treatment protocol, each participating institution is required to complete a 3D Facility Questionnaire documenting their 3D treatment planning capability. In addition, the successful completion of a protocol "dry run" test is required to demonstrate the participating institution's ability to submit a protocol complaint digital data set to the 3D QA Center prior to placing patients on the 3D CRT study. Two site specific (prostate and lung) phase I/II 3D dose escalation trials are currently accruing patients. The QA center reviews at a minimum the first 5 cases from each participating institution and spot checks subsequent submissions. For each case review the following parameters are evaluated: 1. data exchange compliance, 2. CT data quality, 3. target volume contours, 4. normal structure contours, 5. field placement, 6. field shape, 7. dose prescription, 8. dose uniformity, and 9. dose conformity. By April 1997, over 300 protocol patient TPV data sets have been submitted and reviewed by the 3D QA Center.

摘要

1992年,在放射治疗肿瘤学组(RTOG)的支持下,马林克罗特放射研究所成立了三维质量保证(3D QA)中心。3D QA中心的作用是为参与多机构三维放射治疗方案的患者提供外照射治疗计划和验证(TPV)信息的质量保证审查。已实施计算机硬件和软件组件,使参与机构能够(通过互联网或磁带)提交通用格式的3D TPV数据进行QA审查,包括:容积CT图像数据、正常结构、肿瘤和靶区轮廓、数字重建射线照片或模拟定位(处方)及射野片、射束几何形状、剂量分布、分割信息和剂量体积直方图。在将患者纳入三维放射治疗方案之前,每个参与机构都需要完成一份三维设施调查问卷,记录其三维治疗计划能力。此外,还需要成功完成方案“预演”测试,以证明参与机构在将患者纳入三维适形放疗研究之前,有能力向3D QA中心提交符合方案的数字数据集。目前有两项针对特定部位(前列腺和肺)的I/II期三维剂量递增试验正在招募患者。QA中心至少审查每个参与机构的前5例病例,并对后续提交的病例进行抽查。对于每个病例审查,评估以下参数:1. 数据交换合规性,2. CT数据质量,3. 靶区轮廓,4. 正常结构轮廓,5. 射野布置,6. 射野形状,7. 剂量处方,8. 剂量均匀性,9. 剂量适形性。到1997年4月,3D QA中心已提交并审查了300多个方案患者的TPV数据集。

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