Development of the optimal treatment schedule on high-dose-rate intracavitary brachytherapy for uterine cervical cancer

1)采用高剂量率腔内近距离放射治疗I、II期宫颈癌的多机构前瞻性临床研究正在进行中。从2004年9月24日开始病人入院。计算出的目标样本量为60。这项研究的估计应计阶段为3年。行政办公室设在国家肿瘤中心医院放射肿瘤科。数据由大阪大学医学物理与工程学系管理。2)这项研究得到了IRB在16个机构的批准。在撰写本文时(2006年4月25日)，已有30名患者进入研究。3)为了确保本研究中使用的放射治疗质量，成立了质量保证(QA)和质量控制(QC)委员会。QA/QC委员会于2006.4年2月4日对15名接受放射治疗的患者进行了首次QA审查)我们将继续进行放射治疗的患者录入、数据管理和QA审查。关闭患者条目后，将对数据进行分析，并将结果提交给国际期刊。

1)Multi-institutional prospective clinical study of definitive radiotherapy using high-dose-rate intracavitary brachytherapy for stage I, II uterine cervical cancer is ongoing. Patient entry started from September 24, 2004. Target sample size was calculated to be 60. The estimated accrual phase of the study is 3 years. Administrative office is placed in the Department of Radiation Oncology, National Cancer Center Hospital. The data is managed in the Department of Medical Physics and Engineering, Osaka University.2)This study was approved by IRB in 16 institutions. At the time of this writing (April 25, 2006), 30 patients have been entered into the study.3)To keep the quality of radiotherapy utilized in this study, quality assurance (QA) and quality control (QC) committee was organized. The QA/QC committee performed the first QA review of radiotherapy on 15 patients treated on February 4, 2006.4)We will continue the patient entry, data management, and QA review on radiotherapy. After closing the patient entry, data will be analyzed and the results will be submitted to the international journals.