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一项针对头颈癌加速放疗的澳大拉西亚III期试验(TROG 91.01)中的质量保证审计。跨塔斯曼放射肿瘤学组。

Quality assurance audit in an Australasian phase III trial of accelerated radiotherapy for head and neck cancer (TROG 91.01). Trans-Tasman Radiation Oncology Group.

作者信息

Hamilton C, Poulsen M, Walker Q, Krawitz H, Hindley A, Spry N, Peters L, Lamb D, Denham J, Steigler A

机构信息

Department of Radiation Oncology, Newcastle Mater Misericordiae Hospital, New South Wales, Australia.

出版信息

Australas Radiol. 1999 May;43(2):227-32. doi: 10.1046/j.1440-1673.1999.00639.x.

Abstract

The Trans-Tasman Radiation Oncology Group (TROG) initiated a randomized trial, testing accelerated (twice daily) radiotherapy against conventional radiotherapy for stage III and stage IV squamous cell carcinoma of the head and neck in 1991. In 1996, the Trial Management Committee arranged for a technical audit of 76 cases from 11 institutions, conducted by investigators from interstate institutions. A 10% unacceptable protocol violation rate was detected, which compares favourably with initial Radiation Therapy Oncology Group (RTOG) experience in the late 1970s. Infrastructural deficits with poor quality of documentation, incomplete retrieval of films and document return have been demonstrated in some cases. The Trans-Tasman Radiation Oncology Group is actively pursuing procedural and resourcing issues in order to redress this and is actively expanding its Quality Assurance (QA) Programme with an intercentre dosimetry study. Ultimately, comprehensive clinical and technical QA site visits are planned.

摘要

1991年,跨塔斯曼放射肿瘤学组(TROG)启动了一项随机试验,比较加速放疗(每日两次)与传统放疗对头颈部III期和IV期鳞状细胞癌的疗效。1996年,试验管理委员会安排了一项由州际机构的研究人员对来自11个机构的76例病例进行的技术审核。发现了10%的不可接受方案违反率,这比20世纪70年代末放射治疗肿瘤学组(RTOG)最初的经验要好。在一些病例中,已证明存在记录质量差、胶片检索不完整和文件返还等基础设施缺陷。跨塔斯曼放射肿瘤学组正在积极解决程序和资源问题以纠正这一情况,并通过一项中心间剂量测定研究积极扩大其质量保证(QA)计划。最终,计划进行全面的临床和技术QA现场访问。

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