{"database":"ecrin-mdr-crc","file_versions":[],"scores":null,"additional":{"omics_type":["Clinical"],"study_start_year":["2004"],"condition":["Inoperable liver metastases of colorectal cancer"],"disease":["Inoperable Liver Metastases Of Colorectal Cancer"],"study_type":["Interventional"],"full_dataset_link":["https://newmdr.ecrin.org/Study/2413517"],"location":["Slovenia"],"study_start_month":["1"],"keyword":["Cepecitabin and Irinotecan"],"repository":["ECRIN MDR"],"study_status":["Completed"],"additional_accession":[]},"is_claimable":false,"name":"Prospective randomised clinical trial phase II: 5-fluorouracil/folinic acid (5-FU/FA) and irinotecan versus combination cepecitabin and irinotecan in patients with metastatic colorectal cancer as first line treatment","description":"Study hypothesis: There will be no statistically significant differences in efficacy, safety and survival of XELIRI regimen compared to standard FOLFIRI regimen in neoadjuvant setting of patients with unresectable liver-only metastases of colorectal cancer.\nPrimary outcome(s): During the therapy, the following were assessed at baseline, 3 and 6 months, thereafter follow-up was every 3 months until progression of the disease (no limit on the maximum duration of follow-up):\n1. Response rate: Response Evaluation Criteria in Solid Tumors (RECIST) \n2. Rate of radical surgical resection (R0 resection)","dates":{"creation":"2004-01-15"},"accession":"2413517","cross_references":{"ISRCTN":["ISRCTN19912492"]}}