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肝细胞癌辅助手术治疗III期随机对照试验的先验分布推导

Elicitation of prior distributions for a phase III randomized controlled trial of adjuvant therapy with surgery for hepatocellular carcinoma.

作者信息

Tan Say-Beng, Chung Y-F Alexander, Tai Bee-Choo, Cheung Yin-Bun, Machin David

机构信息

Division of Clinical Trials & Epidemiological Sciences, National Cancer Centre, Singapore, Singapore.

出版信息

Control Clin Trials. 2003 Apr;24(2):110-21. doi: 10.1016/s0197-2456(02)00318-5.

DOI:10.1016/s0197-2456(02)00318-5
PMID:12689733
Abstract

A randomized, controlled clinical trial of radioactive iodine tagged with lipiodol in patients with resected hepatocellular carcinoma was criticized for its early stopping and resulting small sample size. To clarify its results, a new, larger multicenter trial was therefore proposed. This paper describes the elicitation of the pretrial opinions of the investigators involved in the new trial and the construction of appropriate clinical and skeptical prior distributions based on their responses. The prior distributions provide a useful tool in assessing the state of equipoise before the start of the trial. They can also be used in Bayesian analyses, both at the interim stage(s) as well as at the end of the trial. We illustrate these analyses, assuming that the data resulting from the new trial was the same as that obtained in the earlier trial when it was stopped.

摘要

一项关于碘化油标记放射性碘用于肝细胞癌切除术后患者的随机对照临床试验,因提前终止及样本量小而受到批评批评。为阐明其结果,因此提出了一项新的、规模更大的多中心试验。本文描述了参与新试验的研究人员的审前意见征集过程,以及根据他们的回答构建适当的临床和怀疑性先验分布。先验分布为评估试验开始前的平衡状态提供了一个有用的工具。它们也可用于贝叶斯分析,包括在试验的中期阶段以及试验结束时。我们举例说明这些分析,假设新试验产生的数据与早期试验停止时获得的数据相同。

相似文献

1
Elicitation of prior distributions for a phase III randomized controlled trial of adjuvant therapy with surgery for hepatocellular carcinoma.肝细胞癌辅助手术治疗III期随机对照试验的先验分布推导
Control Clin Trials. 2003 Apr;24(2):110-21. doi: 10.1016/s0197-2456(02)00318-5.
2
Following a trial that stopped early: what next for adjuvant hepatic intra-arterial iodine-131 lipiodol in resectable hepatocellular carcinoma?在一项提前终止的试验之后:可切除肝细胞癌中辅助性肝动脉内碘-131碘化油的下一步是什么?
J Clin Oncol. 2002 Mar 15;20(6):1709. doi: 10.1200/JCO.2002.20.6.1709.
3
Hepatocellular carcinoma and adjuvant intra-arterial [131I]Lipiodol.肝细胞癌与辅助性肝动脉内[131I]碘油治疗
Br J Surg. 2002 Nov;89(11):1345-6. doi: 10.1046/j.1365-2168.2002.02191.x.
4
Adjuvant intra-arterial iodine-131-labeled lipiodol for resectable hepatocellular carcinoma: a prospective randomized trial-update on 5-year and 10-year survival.辅助性动脉内注射碘-131标记的超液化碘油用于可切除肝细胞癌:一项关于5年和10年生存率的前瞻性随机试验更新
Ann Surg. 2008 Jan;247(1):43-8. doi: 10.1097/SLA.0b013e3181571047.
5
131-iodine Lipiodol therapy in hepatocellular carcinoma.131碘碘化油治疗肝细胞癌
Q J Nucl Med Mol Imaging. 2009 Jun;53(3):348-55.
6
Adjuvant intra-arterial iodine-131-labelled lipiodol for resectable hepatocellular carcinoma: a prospective randomised trial.辅助性动脉内注射碘-131标记的碘化油治疗可切除肝细胞癌:一项前瞻性随机试验
Lancet. 1999 Mar 6;353(9155):797-801. doi: 10.1016/s0140-6736(98)06475-7.
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Transcatheter internal radiotherapy of hepatoma using radioactive iodized oil (I-131 Lipiodol).使用放射性碘油(I-131 碘油)对肝癌进行经导管内放射治疗。
Nihon Igaku Hoshasen Gakkai Zasshi. 1985 Aug 25;45(8):1176-8.
8
Intra-arterial iodine 131-labeled lipiodol as adjuvant therapy after curative liver resection for hepatocellular carcinoma: a phase 2 clinical study.肝动脉内注射碘131标记的碘化油作为肝细胞癌根治性肝切除术后的辅助治疗:一项2期临床研究。
Arch Surg. 2000 Nov;135(11):1298-300. doi: 10.1001/archsurg.135.11.1298.
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[Possibility of radiotherapy of hepatic cancer by transcatheter arterial embolization with radioactive Lipiodol].经导管动脉栓塞联合放射性碘油治疗肝癌的可能性
Nihon Igaku Hoshasen Gakkai Zasshi. 1984 Jan 25;44(1):96-8.
10
Iodine-131-Lipiodol for hepatocellular carcinoma: the benefits of targeting.用于肝细胞癌的碘-131-碘化油:靶向治疗的益处
J Nucl Med. 1994 Aug;35(8):1318-20.

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