[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100078104":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":12,"centralContacts":7,"locations":7,"responsibleParty":7,"collaborators":7,"id":17,"slug":18,"hasResults":19,"nctId":20,"briefTitle":21,"officialTitle":22,"acronym":7,"eligibilityCriteria":23,"healthyVolunteers":19,"sex":24,"minAge":25,"maxAge":7,"enrollmentInfo":26,"targetDuration":7,"studyType":28,"phases":29,"briefSummary":31,"conditions":32,"keywords":36,"overallStatus":41,"whyStopped":7,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":7},{"fullName":5,"class":6},"Sanofi","INDUSTRY",null,[9],{"type":10,"name":11,"description":7,"armGroupLabels":7,"otherNames":7},"DRUG","SR57746A",[13],{"name":14,"affiliation":15,"role":16},"Gérard SAID, MD","Hôpital de Bicêtre - Le Kremlin-Bicêtre - France","STUDY_CHAIR","100078104","phase-3-xenox---evaluation-of-the-efficacy-of-xaliproden-in-reducing-the-neurotoxicity-of-the-oxaliplatin--5-fulv-chemotherapy-100078104",false,"NCT00272051","XENOX - Evaluation of the Efficacy of Xaliproden in Reducing the Neurotoxicity of the Oxaliplatin + 5-FU\u002FLV Chemotherapy","A Multicenter Randomized Dble-Blind Placebo Controlled Phase III Study of the Efficacy of Xaliproden in Reducing the Neurotoxicity of the Oxaliplatin and 5-FU\u002FLV Combination in First-Line Treatment of Patients With Metastatic Colorectal Carcinoma(MCRC)","Inclusion Criteria:\n\n* Histologically or cytologically proven adenocarcinoma of the colon or the rectum\n* age \\> 18 years\n* WHO performance status : 0,1,2\n* Signed written informed consent prior to study entry\n* Disease stage : metastatic disease not amenable to potentially curative treatment (eg : inoperable metastatic disease)\n* Measurable disease\n* No prior chemotherapeutic regimen for metastatic disease ; prior adjuvant chemotherapy allowed (disease free interval from end of adjuvant therapy of at least 6 months)\n* Prior radiotherapy permitted, if completed at least 3 weeks before randomization, and if not administered to target lesions identified for the study\n\nExclusion Criteria:\n\n* Chemotherapeutic agents other than 5-FU\u002FLV or 5-FU\u002FLevamizole as part of adjuvant therapy\n* Prior therapy with Oxaliplatin\n* History of cardiac toxicities under 5-FU\u002FLV therapy or myocardial infarction within the 6 months before study entry ; Known Dihydropyrimidine Dehydrogenase deficiency\n* History of intolerance to appropriate antiemetics\n* Concurrent active cancer originating from a primary site other than colon or rectum\n* Presence of any symptom suggesting brain metastasis\n* Known peripheral neuropathy\n* Interstitial pneumonia or extensive and symptomatic fibrosis of the lung\n* Allergy to Xaliproden\u002Fexcipients","ALL","18 Years",{"count":27,"type":7},620,"INTERVENTIONAL",[30],"PHASE3","Purpose of the trial is to evaluate the efficacy of Xaliproden in reducing the neurotoxicity of the Oxaliplatin and 5-FU\u002FLV chemotherapy, in patients with metastatic colorectal carcinomaPrimary objectives : Compare the risk of occurence of grade 3-4 peripheral sensory neuropathy relative to the cumulative dose of Oxaliplatin between treatment group and placebo group ; Compare the response rate between treatment group and placebo group.Secondary objectives : neurotoxicity parameters (overall incidence, time and dose to onset, time to recovery, change in the sensory action potentials) ; antitumoral efficacy (progression-free survival, overall survival) ; safety profile.",[33,34,35],"Metastases","Colorectal Neoplasms","Colorectal Carcinoma",[37,38,39,40],"Neurotoxicity syndromes","Paresthesia","Oxaliplatin","Xaliproden","COMPLETED","2006-09-11",{"date":44,"type":45},"2006-09-13","ESTIMATED",{"date":47,"type":7},"2002-07",{"date":49,"type":7},"2004-05",{"name":5,"class":6}]