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

本临床研究的第一个目的是研究亚叶酸钙和替加氟尿嘧啶口服辅助化疗是否可以降低结直肠癌肝转移患者手术切除的复发率。第二个目的是通过检测胸苷酸合成酶（TS）、胸苷磷酸化酶（TP）、二氢嘧啶脱氢酶（DPD）和乳清酸磷酸核糖转移酶（OPRT）的mRNA水平，探讨辅助化疗对预后的影响。需要70名患者登记才能实现目标。本研究的研究期设定为2008年底，但是，我们将研究期延长至2009年底，因为注册速度加快，并且实现目标对于本试验获得一些科学结论很重要。2008年4月8日在东京举行的年度会议决定延长研究期。虽然登记的速度比预期的慢，但目标的实现终于在望。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）。我们将登记180例患者（目标），直到2009年底，并随访至少3年。本研究的结果将在国内外会议上公开发表，并将在一些英文同行评审期刊上发表，在项目期间，我们在一封简短的信中讨论了RCT注册的实际问题，该信发表在Journal of Clinical Oncology（2007; 25：1299 - 1300）上。此外，我们还在科学会议上做了报告，并发表了关于原发性和转移性肝癌手术治疗的文章。

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.