[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100103563":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":15,"centralContacts":7,"locations":19,"responsibleParty":31,"collaborators":7,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":38,"acronym":7,"eligibilityCriteria":39,"healthyVolunteers":36,"sex":40,"minAge":41,"maxAge":7,"enrollmentInfo":42,"targetDuration":7,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":7,"overallStatus":51,"whyStopped":7,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":61},{"fullName":5,"class":6},"Sanofi","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"DRUG","Oxaliplatin, 5-Fluorouracil","5FU 500 mg\u002Fm² per week in IV bolus infusion during 30 min AF 20mg\u002Fm²\u002Fweek in infusion, during 10-20 minutes prior 5FU infusion; Eloxatin 85 mg\u002Fm² as IV infusion 2-6 hours, every 2 weeks. Three weeks of treatment, one week rest.",[14],"Eloxatin, 5FU",[16],{"name":17,"affiliation":5,"role":18},"Juan Carlos Gomez","STUDY_DIRECTOR",[20],{"facility":21,"status":7,"city":22,"state":7,"zip":7,"country":23,"countryCode":24,"cosmosGeoPoint":25,"geoPoint":30,"contacts":7},"Sanofi-Aventis","Bogotá","Colombia","CO",{"type":26,"coordinates":27},"Point",[28,29],-74.08175,4.60971,{"lat":29,"lon":28},{"type":7,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":32,"oldOrganization":33},"Juan Carlos Gomez\u002FStudy Director","sanofi-aventis","100103563","phase-2-a-phase-ii-study-of-oxaliplatin-in-association-with-5fu-and-folinic-acid-in-the-treatment-of-subjects-with-non-surgical-or-advanced-metastatic-gastric-cancer-100103563",false,"NCT00611507","A Phase II Study of Oxaliplatin in Association With 5FU and Folinic Acid in the Treatment of Subjects With Non-Surgical or Advanced Metastatic Gastric Cancer","Inclusion Criteria:\n\n* Histologically proven gastric or gastroesophagic junction adenocarcinoma\n* Measurable disease at least in a unidimensional manner. If a unique metastasis constitutes the only disease symptom, histological confirmation will be required\n* Metastatic or locally non-surgical primary gastric cancer\n* Recurrent gastric cancer after local and\u002For systemic treatment with a post-surgical period of at least 4 weeks, a post-adjuvant chemotherapy period or a neo-adjuvant chemo-radiotherapy of at least 6 months\n* Serum bilirubin\\\u003C 2 mg\u002Fdl\n* Serum creatinine \\\u003C or =to 2 times normal superior limit\n* Absolute neutrophil count \\> or =to 2000\u002Fdl\n* Platelet count \\> or =to 100000\u002Fdl\n* Hemoglobin \\> or =to 10 g\u002Fdl\n* AST\u002FALT \\\u003C or =to 2.5 times normal superior institutional limit\n* Alkaline phosphatase \\\u003C or =to 5 times the normal superior institutional limit\n* Age \\> 18 years\n* Performance Status ECOG 0-2\n* Written informed consent signed and dated\n\nExclusion Criteria:\n\n* Symptomatic sensory peripheral neuropathy\n* Uncontrolled concomitant disease.(e.g. severe diabetes mellitus, arterial hypertension)\n* Any other malignancy diagnosed within 5 years previous to the gastric cancer, with the exception of \" in situ \" cervix carcinoma or non-melanoma skin cancer\n* Concomitant anti-tumoral treatment\n* Cerebral metastases\n* Unstable heart disease, even though under treatment\n* Myocardial infarction within the last 6 months\n* Pregnancy or nursing (or women in reproductive life without adequate contraception)\n* Significant neurological or psychiatric disorders","ALL","18 Years",{"count":43,"type":44},21,"ACTUAL","INTERVENTIONAL",[47],"PHASE2","This phase II trial will evaluate, in first line advanced or metastatic gastric cancer, the efficacy and tolerance of another oxaliplatin, 5FU bolus combination already tested in advanced colorectal cancer",[50],"Stomach Neoplasms","COMPLETED","2008-03-24",{"date":54,"type":55},"2008-03-25","ESTIMATED",{"date":57,"type":7},"2002-11",{"date":59,"type":44},"2004-04",{"name":5,"class":6},1]