{"groups":[{"description":"Cetuximab intravenous infusion of 400mg/m\\^2 for the first infusion then weekly intravenous infusion of 250mg/m\\^2. Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops","id":"FG000","title":"Cetuximab Plus FOLFIRI"},{"description":"Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops","id":"FG001","title":"FOLFIRI Alone"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"2"}],"type":"investigational study phase ongoing"}],"milestones":[{"achievements":[{"comment":"Randomized and treated subjects; 1 additional subject was treated but not randomised","groupId":"FG000","numSubjects":"599"},{"comment":"Randomized and treated subjects; 3 additional subjects were treated but not randomised","groupId":"FG001","numSubjects":"599"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"592"},{"groupId":"FG001","numSubjects":"597"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"2"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"At the prescreening visit the subject completed the first informed consent form, and a sample of tumor tissue for determination of EGFR expression was to be obtained.\n\nThe screening (baseline) visit was performed no more than 21 days before randomization. EGFR-expressing subjects completed a second informed consent form to participate in the study.","recruitmentDetails":"First/Last subject in: 10 Aug 2004/4 Nov 2005. Clinical cut-off efficacy analyses except survival: 27 Jul 2006, Cut off date IRC data: 14 Dec 2006; cut-off safety analyses: 30 Nov 2007; cut-off survival analyses: 31 May 2009; cut-off KRAS analyses: 28 Aug 2009.\n\n1221 subjects were randomised or treated, of whom 1198 were randomised and treated."}