[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100265461":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":18,"centralContacts":22,"locations":27,"responsibleParty":48,"collaborators":18,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":18,"studyType":64,"phases":65,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":30,"whyStopped":18,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Centre Hospitalier Universitaire de Besancon","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase I","EXPERIMENTAL","* for chemotherapy 3 levels: 50%, 75% and 100% of the standard Dutch dose (carboplatin AUC 2 and paclitaxel 50 mg\u002Fm2)\n* for radiotherapy 3 levels: 41.4 Gy\u002F1.8 Gy\u002Ff; 45 Gy\u002F1.8 Gy\u002Ff; 50.4 Gy\u002F1.8 Gy\u002Ff basel level being : 41.4 Gy and 50% of standard CT doses The phase I is conducted with increasing doses of each component with 9 levels.",[13],"Drug: Carboplatin",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Carboplatin",null,[9],[21],"Paclitaxel",[23],{"name":24,"role":25,"phone":18,"phoneExt":18,"email":26},"Jihane BOUSTANI, Dr","CONTACT","jboustani@chu-besancon.fr",[28],{"facility":29,"status":30,"city":31,"state":18,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Centre Hospitalier Universitaire de Besançon","RECRUITING","Besançon","25000","France","FR",{"type":36,"coordinates":37},"Point",[38,39],6.01815,47.24878,{"lat":39,"lon":38},[42,45],{"name":43,"role":25,"phone":18,"phoneExt":18,"email":44},"Elise ROBERT","e1robert@chu-besancon.fr",{"name":46,"role":47,"phone":18,"phoneExt":18,"email":18},"Jihane BOUSTANI, PH","PRINCIPAL_INVESTIGATOR",{"type":49,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100265461","phase-1-chemoradiotherapy-in-elderly-patients-with-oesophagus-cancer-100265461",false,"NCT02735057","Chemoradiotherapy in Elderly Patients With Oesophagus Cancer","Phase I-II Study Chemoradiation in Elderly Patients With Oesophagus Cancer","OSAGE","Inclusion Criteria:\n\n* Esophageal cancer, squamous and adenocarcinoma types, T1-3, N0-1, M1a (TNM 6th),\n* age \\> 75 years,\n* WHO status \\\u003C 2, Balducci 1, adequate bone marrow reserve, normal renal and hepatic function.\n\nExclusion Criteria:\n\n* age \\\u003C 75 years","ALL","75 Years","100 Years",{"count":62,"type":63},54,"ESTIMATED","INTERVENTIONAL",[66,67],"PHASE1","PHASE2","Management of elderly patient with cancer is a therapeutic challenge and a public health problem. The mean age of esophageal cancer is 64.5 years and 72.1 years in men and women respectively. Surgery is a standard treatment reserved to about 30 % of patients. The other 70 % are considered unfit for surgery for various reasons, including ageing.\n\nChemoradiotherapy (CRT) is standard treatment for patients with esophageal cancer unfit for surgery. The validated treatment scheme is external beam radiotherapy (EBRT) 50 Gy over 5 weeks combined with cisplatin and 5FU infusion. However it induces high rates of severe and life threatening toxicities: grade 3 haematologic and esophageal mucositis of 20 and 25 % respectively, in patients with a median age of 64 years. CRT has not been properly evaluated in patients more than 75 years, and other combined chemotherapy are challenging.",[70,71],"Oesophagus Cancer","Elderly Patients",[73],"oesophagus cancer","2024-01-17",{"date":76,"type":77},"2024-01-18","ACTUAL",{"date":79,"type":77},"2016-04-04",{"date":81,"type":63},"2029-05-16",{"name":5,"class":6},1]