[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551754":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":16,"studyPopulation":30,"armGroups":31,"interventions":37,"overallOfficials":43,"centralContacts":48,"locations":57,"responsibleParty":76,"collaborators":16,"id":78,"slug":16,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":16,"eligibilityCriteria":82,"healthyVolunteers":79,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":89,"studyType":90,"phases":16,"briefSummary":91,"conditions":92,"keywords":16,"overallStatus":60,"whyStopped":16,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University of Erlangen-Nürnberg Medical School","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Creation of a database","Creation of a database of a representative homogeneously treated patient cohort with locally advanced salivary gland tumours receiving postoperative radiochemotherapy.","63 months (12 weeks therapy plus 5 years follow-up)",[14,17,19,21,23,25],{"measure":15,"description":16,"timeFrame":12},"Observation of Overall survival",null,{"measure":18,"description":16,"timeFrame":12},"Observation of Disease-free survival",{"measure":20,"description":16,"timeFrame":12},"Observation of Disease-specific survival",{"measure":22,"description":16,"timeFrame":12},"Observation of Local recurrence-free survival",{"measure":24,"description":16,"timeFrame":12},"Observation of Survival free of distant metastases",{"measure":26,"description":16,"timeFrame":12},"Determination of toxicity",{"allocation":16,"interventionModel":16,"interventionModelDescription":16,"primaryPurpose":16,"observationalModel":28,"timePerspective":29,"maskingInfo":16},"COHORT","PROSPECTIVE","Patients with locally advanced high-grade salivary gland carcinoma after oncological resection who fulfil the inclusion and exclusion criteria are included. Patients must be adequately informed about their diagnosis and about the nature, significance and scope of the study.",[32],{"label":33,"type":16,"description":34,"interventionNames":35},"Patient","Patients with locally advanced high-grade salivary gland carcinoma after oncological resection",[36],"Procedure: simultaneous postoperative radiochemotherapy",[38],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":16},"PROCEDURE","simultaneous postoperative radiochemotherapy","The efficacy and tolerability of simultaneous postoperative radiochemotherapy is being investigated.",[33],[44],{"name":45,"affiliation":46,"role":47},"Marlen Haderlein, PD Dr.","Universitätsklinikum Erlangen, Strahlenklinik","PRINCIPAL_INVESTIGATOR",[49,54],{"name":45,"role":50,"phone":51,"phoneExt":52,"email":53},"CONTACT","0913185","33968","marlen.haderlein@uk-erlangen.de",{"name":55,"role":50,"phone":51,"phoneExt":52,"email":56},"Studiensekretariat","studiensekretariat.ST@uk-erlangen.de",[58],{"facility":59,"status":60,"city":61,"state":16,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Erlangen, Universitätsklinikum Strahlenklinik","RECRUITING","Erlangen","91054","Germany","DE",{"type":66,"coordinates":67},"Point",[68,69],11.00783,49.59099,{"lat":69,"lon":68},[72,74],{"name":45,"role":50,"phone":73,"phoneExt":52,"email":53},"+499131-85-",{"name":55,"role":50,"phone":75,"phoneExt":52,"email":56},"+49 9131 85-",{"type":77,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100551754",false,"NCT06464198","Prospective Registry Study on the Implementation of Simultaneous Postoperative Radiochemotherapy for Salivary Gland Carcinomas of the Head and Neck Region","Inclusion Criteria:\n\n* Salivary gland carcinomas of the major and minor salivary glands of the head and neck region\n* High-grade histology\n* Successful oncological resection with curative intent\n* pT3-4 or pN1-3 or Pn1(perineural sheath infiltration) or pT1-2 with scarce or positive resection margin\n* cM0\n* Indication for postoperative combined radiochemotherapy (guideline-compliant radiochemotherapy; percutaneous radiotherapy up to a total dose of 64-72 Gy (depending on resection status), common chemotherapy regimens: Paclitaxel 135mg\u002Fm² KOF d1 and cisplatin 33mg\u002Fm² KOF d1-3, q d22 or paclitaxel 135mg\u002Fm² KOF d1, carboplatin AUC 1.5 KOF d1-3 or paclitaxel 50mg\u002Fm² KOF, carboplatin AUC2 d1,8,15, q d22 or paclitaxel 50mg\u002Fm²KOF and cisplatin 30mg\u002Fm² KOF d1,8,15, q d22, 4 cycles each).\n* Patient age ≥18 years\n* WHO performance score ≤ 1\n* Signed patient information\u002Fconsent form\n\nExclusion Criteria:\n\n* Distant metastases\n* Other cancer in the last 5 years prior to study inclusion (with the exception of: adequately treated skin cancer (except melanoma) or lentigo maligno or adequately treated carcinoma in situ, in each case without evidence of active disease).\n* Previous chemotherapy or radiotherapy for salivary gland carcinoma\n* Previous radiotherapy in the head and neck area\n* Pre-existing uncontrolled disease that constitutes a contraindication to simultaneous combination chemotherapy (e.g. signs of acute heart failure, myocardial infarction within the last 6 months before the start of therapy, congestive heart failure, heart disease with New York Heart Association (NYHA) III or IV classification, active and therapy-resistant infection, pre-existing or concomitant immunodeficiency syndrome)\n* Pregnancy and breastfeeding\n* Fertile patients who cannot ensure effective contraception during and up to six months after combination therapy","ALL","18 Years","99 Years",{"count":87,"type":88},100,"ESTIMATED","5 Years","OBSERVATIONAL","This is a prospective registry study based on a standard therapy concept for postoperative simultaneous radiochemotherapy established in Erlangen and elsewhere. The efficacy and tolerability of simultaneous postoperative radiochemotherapy is being investigated. Patients with locally advanced high-grade salivary gland carcinoma after oncological resection are admitted.",[93],"Locally Advanced Salivary Gland Carcinoma","2026-03-11",{"date":96,"type":97},"2026-03-13","ACTUAL",{"date":99,"type":97},"2024-06-01",{"date":101,"type":88},"2037-06",{"name":5,"class":6},1]