Clinical research of adjuvant chemotherapy to prevent recurrence after surgical resection for liver metastasis from colorectal cancer

辅助化疗预防结直肠癌肝转移术后复发的临床研究

• 批准号: 17591377
• 负责人: KOKUDO Norihiro
• 金额: $ 2.24万
• 依托单位: The University of Tokyo
• 依托单位国家: 日本
• 项目类别: Grant-in-Aid for Scientific Research (C)
• 财政年份: 2005
• 资助国家: 日本
• 起止时间: 2005 至 2007
• 项目状态: 已结题
• 来源: https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-17591377/
• 关键词: Cancer; Surgery; Chemotherapy; Metastasis; 転移性肝癌; 肝切除; 補助化学療法; UFT; 経口ロイコボリン

The first aim of this clinical research is to investigate whether oral adjuvant chemotherapy using calcium folinate and tegafur uracil can decrease recurrence rate in patients undergoing surgical resection for liver metastasis from colorectal cancer. The second aim is to investigate the clinical effects of this adjuvant chemotherapy on prognosis by measuring mRNA level of TS (thymidylate synthase), TP (thymidine phosphorylase), DPD (dihydropyrimidine dehydrogenase), and OPRT (orotate phosphoribosyltrasferase) in the resected cancerous tissue.Between February 2004 and March 2008, total 110 patients have been registered. Registration of 70 patients is needed to the goal. The study period was set until the end of 2008, however, we extend the period until the end of 2009, because the pace of registration has been promoted and achievement of the goal is important to obtain some scientific conclusion in this trial. This extension of the study period was determined in the annual meeting held in April8 2008 in Tokyo. Although the registration pace is slower than was expected, the achievement of the goal is at last in sight. For the second aim, we have gathered the resected specimen of all registered patients, and will measure mRNA level (TS, TP, DPD, OPRT) after the achievement of the goal. We will register 180 patients (goal) until the end of 2009, and follow them up for at least 3 years. The results of this study will be acknowledged to the public in domestic and international meetings, and will be published in some English peer-reviewed journals.During the term of project, we discussed the practical problems about the registration of RCT in a short letter, which was published in Journal of Clinical Oncology (2007; 25:1299-1300). In addition, we have done presentation in scientific meetings and published articles concerning surgical treatment for primary and metastatic liver carcinomas.

本临床研究的首要目的是探讨亚叶酸钙联合替加富尿嘧啶口服辅助化疗是否能降低结直肠癌肝转移手术切除患者的复发率。二是通过检测切除癌组织中胸腺嘧啶合成酶（TS）、胸腺嘧啶磷酸化酶（TP）、二氢嘧啶脱氢酶（DPD）、角化磷酸核糖基转移酶（OPRT） mRNA水平，探讨该辅助化疗对预后的临床影响。在2004年2月至2008年3月期间，共有110名患者登记。要实现这一目标，需要登记70名患者。研究期原定到2008年底，但我们将研究期延长到2009年底，因为注册的速度加快了，实现目标对本次试验获得一些科学结论很重要。在2008年4月8日于东京举行的年度会议上决定延长研究期限。虽然注册速度比预期的要慢，但目标的实现终于在望了。对于第二个目标，我们收集了所有登记患者的切除标本，并将在目标实现后测量mRNA水平（TS， TP， DPD， OPRT）。到2009年底，我们将登记180例患者（目标），并对他们进行至少3年的随访。本研究结果将在国内和国际会议上向公众承认，并将在一些英文同行评议期刊上发表。在项目期间，我们在一封简短的信件中讨论了RCT注册的实际问题，并发表在Journal of Clinical Oncology（2007; 25:1299-1300）。此外，我们还在科学会议上做了报告，并发表了有关原发性和转移性肝癌手术治疗的文章。

项目成果

Estimation of standard liver volume in Japanese living liver donors

• DOI: 10.1111/j.1440-1746.2006.04433.x
• 发表时间: 2006-11-01
• 期刊: JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY
• 影响因子: 4.1
• 作者: Hashimoto, Takuya;Sugawara, Yasuhiko;Makuuchi, Masatoshi
• 通讯作者: Makuuchi, Masatoshi

Three-dimensional computed tomography for planning donor hepatectomy

三维计算机断层扫描用于规划供体肝切除术

• 发表时间: 2007
• 期刊: Transpl Proc 39
• 作者: Satou S;Sugawara Y;Tamura S;Kishi Y;KanekoJ;Matsui Y;Kokudo N;Makuuchi M
• 通讯作者: Makuuchi M

C.肝癌治療の実際1.肝切除

三、肝癌治疗实践 1. 肝脏切除术

• 发表时间: 2007
• 期刊: 肝癌診療マニュアル/日本肝臓学会・編 13(1):
• 作者: 國土典宏;幕内雅敏
• 通讯作者: 幕内雅敏

巻頭言 特集に寄せて:知っておくべき胆嚢癌の治療方針

前言 关于专题：你应该知道的胆囊癌治疗政策

• 发表时间: 2007
• 期刊: 外科 69(11)
• 作者: 幕内雅敏;國土典宏
• 通讯作者: 國土典宏

O-377 A randomized trial to evaluate UFT adjuvant therapy to prevant postoperative recurrence of HCC

O-377 一项评估 UFT 辅助治疗预防 HCC 术后复发的随机试验

• 发表时间: 2007
• 期刊: Hepatology International 1:3-242
• 作者: Kiyoshi Hasegawa;Tadatoshi Takayama;Masayoshi Izichi Yutaka Matsuyama;Hiroshi Imamura;Keiji Sano;Yasuhiko Sugawara;Norihiro Kokudo;Masatoshi Makuuchi
• 通讯作者: Masatoshi Makuuchi