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

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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.