{"database":"ecrin-mdr-crc","file_versions":[],"scores":null,"additional":{"omics_type":["Clinical"],"study_start_year":["2012"],"condition":["Fatty Liver","Steatohepatitis","Colorectal Cancer","Colorectal Neoplasms","first-line palliative treated, KRAS-Wild-Type, metastatic colorectal cancer"],"disease":["Fatty Liver","Steatohepatitis","Colorectal Cancer","First-line Palliative Treated, Kras-wild-type, Metastatic Colorectal Cancer","Colorectal Neoplasms"],"study_type":["Interventional"],"full_dataset_link":["https://newmdr.ecrin.org/Study/2119641"],"location":["Austria"],"study_start_month":["4"],"keyword":["5-fluorouracil","Irinotecan","Chemotherapy","Folinic acid (Leucovorin)","Placebo","KRAS-Wild-Type","Metformin","Cetuximab","Metastatic colorectal cancer","Steatosis","Liver injury"],"repository":["ECRIN MDR"],"study_status":["Terminated"],"additional_accession":[]},"is_claimable":false,"name":"A Randomized, Placebo-controlled, Double-blind Phase II Study Evaluating if Glucophage Can Avoid Liver Injury Due to Chemotherapy Associated Steatosis","description":"This multicenter randomized, placebo-controlled phase II study will enroll 132 first-line palliative treated subjects with metastatic KRAS wild type CRC. Subjects with histologically confirmed, KRAS wild-type CRC without previous chemo-therapy for metastatic disease will be screened for this study.\nApproximately 10 sites in Austria will participate in the study. Subjects will be randomized in a ratio of 1:1 into two groups.","dates":{"creation":"2012-04-15"},"accession":"2119641","cross_references":{"ClinicalTrials___gov":["NCT01523639"],"EU Clinical Trials Register":["2011-001010-34"]}}