<HashMap><database>ecrin-mdr-crc</database><scores/><additional><omics_type>Clinical</omics_type><study_start_year>2004</study_start_year><condition>Inoperable liver metastases of colorectal cancer</condition><disease>Inoperable Liver Metastases Of Colorectal Cancer</disease><study_type>Interventional</study_type><full_dataset_link>https://newmdr.ecrin.org/Study/2413517</full_dataset_link><location>Slovenia</location><study_start_month>1</study_start_month><keyword>Cepecitabin and Irinotecan</keyword><repository>ECRIN MDR</repository><study_status>Completed</study_status></additional><is_claimable>false</is_claimable><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</name><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.
Primary 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):
1. Response rate: Response Evaluation Criteria in Solid Tumors (RECIST) 
2. Rate of radical surgical resection (R0 resection)</description><dates><creation>2004-01-15</creation></dates><accession>2413517</accession><cross_references><ISRCTN>ISRCTN19912492</ISRCTN></cross_references></HashMap>