{"database":"ecrin-mdr-crc","file_versions":[],"scores":null,"additional":{"omics_type":["Clinical"],"study_start_year":["2006"],"condition":["Colorectal cancer","Colorectal Neoplasms"],"disease":["Colorectal Cancer","Colorectal Neoplasms"],"study_type":["Interventional"],"full_dataset_link":["https://newmdr.ecrin.org/Study/2044346"],"location":["South Korea"],"study_start_month":["8"],"keyword":["Oxaliplatin","Phase I/II study","TS-1 and oxaliplatin","First line treatment"],"repository":["ECRIN MDR"],"study_status":["Completed"],"additional_accession":[]},"is_claimable":false,"name":"A Phase I/II Trial of TS-1 and Oxaliplatin in Patients With Advanced Colorectal Cancer","description":"Capecitabine and oxaliplatin(XELOX) is active first-line therapy for patients with metastatic colorectal cancer. Phase II study of TS-1, a novel oral fluoropyrimidine derivative, showed activity in patients with metastatic colorectal carcinoma. Preclinical data of TS-1 with oxaliplatin showed synergistic activity in vivo human colorectal cancer xenograft. There is no data about the optimal dose of TS-1 with 2 weeks schedule combined with oxaliplatin. Therefore in a phase I study, we would like to determine the maximum tolerated dose(MTD) of TS-1 and oxaliplatin and define the recommended dose for subsequent phase II study. And then, in a phase II study we would like to evaluate the efficacy(response rates) and toxicities of the new combination regimen in advanced colorectal cancer.","dates":{"creation":"2006-08-15"},"accession":"2044346","cross_references":{"ClinicalTrials___gov":["NCT00531245"]}}