[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100511986":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":19,"locations":27,"responsibleParty":44,"collaborators":10,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":10,"enrollmentInfo":56,"targetDuration":10,"studyType":59,"phases":10,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":78,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Patients treated by chemoradiotherapy with high dose of cisplatin",null,"radiotherapy 60-70 Gy in 30-35 fractions with concomitant chemotherapy by cisplatin 100 mg\u002Fm2 every 3 weeks (week 1, 3 and 7)",{"label":13,"type":10,"description":14,"interventionNames":10},"Patients treated with exclusive radiotherapy or radiotherapy with non-ototoxic chemotherapy","patient ineligible for chemotherapy with cisplatin:\n\n* exclusive radiotherapy: 60-70 Gy in 30-35 fractions\n* radiotherapy with a non-ototoxic chemotherapy (due to contraindication to cisplatin): 60-70 Gy in 30-35 fractions",[16],{"name":17,"affiliation":5,"role":18},"Florence HUGUET, MD, PhD","PRINCIPAL_INVESTIGATOR",[20,24],{"name":17,"role":21,"phone":22,"phoneExt":10,"email":23},"CONTACT","0033 (0) 1 56 01 62 10","Florence.huguet@aphp.fr",{"name":25,"role":21,"phone":10,"phoneExt":10,"email":26},"Rafik NEBBACHE, Resident","Rafik.nebbache@aphp.fr",[28],{"facility":29,"status":10,"city":30,"state":10,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Radiotherapy Oncology Service TENON Hospital","Paris","75020","France","FR",{"type":35,"coordinates":36},"Point",[37,38],2.3488,48.85341,{"lat":38,"lon":37},[41,43],{"name":17,"role":21,"phone":42,"phoneExt":10,"email":23},"33 (0) 1 56 01 62 10",{"name":25,"role":21,"phone":10,"phoneExt":10,"email":26},{"type":45,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100511986","association-between-tinnitus-and-hearing-loss-in-locally-advanced-head-and-neck-cancer-treated-by-radiotherapy-alone-or-with-chemotherapy-a-prospective-and-multicenter-study-100511986",false,"NCT05946577","Association Between Tinnitus and Hearing Loss in Locally Advanced Head and Neck Cancer Treated by Radiotherapy Alone or With Chemotherapy: a Prospective and Multicenter Study","Association Between Tinnitus and Hearing Loss in Patients With Locally Advanced Head and Neck Cancer Treated by Concomitant Chemoradiotherapy or Exclusive Radiotherapy: a Prospective and Multicenter Study","AURACCO","Inclusion Criteria:\n\n* Patient with locally advanced or post-operative ENT cancer with high risk of recurrence\n* Patient ≥ 18 years\n* Absence of prior chemotherapy or radiotherapy\n* Patient eligible for chemotherapy with cisplatin according to the standard regimen: radiotherapy delivering 60-70 Gy in 30-35 fractions spread over 6 to 7 weeks associated with chemotherapy with cisplatin 100 mg\u002Fm2 every 3 weeks (i.e. at week 1, 4 and 7)\n* Patient ineligible for cisplatin chemotherapy receiving:\n\n  * Either exclusive radiotherapy (age \\> 70 years, contraindication: renal failure, patient wearing a device): radiotherapy delivering 60-70 Gy in 30-35 fractions spread over 6 to 7 weeks.\n  * either chemoradiotherapy with a chemotherapy protocol different from the standard scheme (due to a contraindication to cisplatin): radiotherapy delivering 60-70 Gy in 30-35 fractions spread over 6 to 7 weeks associated with non-standard chemotherapy ototoxic (cetuximab or carboplatin-5FU)\n\nExclusion Criteria:\n\n* Tinnitus grade ≥ 2 according to the SOMA-LENT scale\n* Patient fitted for hearing disorders\n* Significant cognitive disorders that may compromise the performance of the various assessments\n* Patients treated with weekly cisplatin\n* Patient's refusal to participate in research","ALL","18 Years",{"count":57,"type":58},140,"ESTIMATED","OBSERVATIONAL","The aim of the AURACCO study is to evaluate the association between the onset of tinnitus and hearing loss in patients with locally advanced head and neck cancer treated by concomitant chemoradiotherapy or exclusive radiotherapy",[62,63],"Head Cancer","Neck Cancer",[65,66,67,68,69,70,71,72,73,74,75,76,77],"Head and neck cancer","HNSCC","Undifferentiated nasopharyngeal cancer","UCNT","Salivary gland cancer","Radiotherapy","Chemoradiotherapy","Radiochemotherapy","Chemotherapy","Cisplatin","Ototoxicity","Tinnitus","Hearing loss","NOT_YET_RECRUITING","2023-07-07",{"date":81,"type":82},"2023-07-14","ACTUAL",{"date":84,"type":58},"2023-07",{"date":86,"type":58},"2026-09",{"name":5,"class":6},1]