[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551754":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":53,"collaborators":10,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":10,"eligibilityCriteria":60,"healthyVolunteers":57,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":67,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":10,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"University of Erlangen-Nürnberg Medical School","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patient",null,"Patients with locally advanced high-grade salivary gland carcinoma after oncological resection",[13],"Procedure: simultaneous postoperative radiochemotherapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"PROCEDURE","simultaneous postoperative radiochemotherapy","The efficacy and tolerability of simultaneous postoperative radiochemotherapy is being investigated.",[9],[21],{"name":22,"affiliation":23,"role":24},"Marlen Haderlein, PD Dr.","Universitätsklinikum Erlangen, Strahlenklinik","PRINCIPAL_INVESTIGATOR",[26,31],{"name":22,"role":27,"phone":28,"phoneExt":29,"email":30},"CONTACT","0913185","33968","marlen.haderlein@uk-erlangen.de",{"name":32,"role":27,"phone":28,"phoneExt":29,"email":33},"Studiensekretariat","studiensekretariat.ST@uk-erlangen.de",[35],{"facility":36,"status":37,"city":38,"state":10,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Erlangen, Universitätsklinikum Strahlenklinik","RECRUITING","Erlangen","91054","Germany","DE",{"type":43,"coordinates":44},"Point",[45,46],11.00783,49.59099,{"lat":46,"lon":45},[49,51],{"name":22,"role":27,"phone":50,"phoneExt":29,"email":30},"+499131-85-",{"name":32,"role":27,"phone":52,"phoneExt":29,"email":33},"+49 9131 85-",{"type":54,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100551754","prospective-registry-study-on-the-implementation-of-simultaneous-postoperative-radiochemotherapy-for-salivary-gland-carcinomas-of-the-head-and-neck-region-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":65,"type":66},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.",[71],"Locally Advanced Salivary Gland Carcinoma","2026-03-11",{"date":74,"type":75},"2026-03-13","ACTUAL",{"date":77,"type":75},"2024-06-01",{"date":79,"type":66},"2037-06",{"name":5,"class":6},1]