[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588919":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":17,"locations":26,"responsibleParty":52,"collaborators":10,"id":54,"slug":10,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":10,"enrollmentInfo":62,"targetDuration":10,"studyType":65,"phases":10,"briefSummary":66,"conditions":67,"keywords":10,"overallStatus":28,"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":10},"Treatment group",null,"Patients with squamous cell carcinoma of the head and neck without distant metastases, for whom definitive or postoperative chemoradiation is indicated and who are unfit for cisplatin.",[13],{"name":14,"affiliation":15,"role":16},"Marlen Haderlein, MD","Universitätsklinikum Erlangen, Strahlenklinik","PRINCIPAL_INVESTIGATOR",[18,23],{"name":14,"role":19,"phone":20,"phoneExt":21,"email":22},"CONTACT","+49913185","33968","marlen.haderlein@uk-erlangen.de",{"name":24,"role":19,"phone":20,"phoneExt":21,"email":25},"Charlotte Schmitter, MD","charlotte.schmitter@uk-erlangen.de",[27],{"facility":15,"status":28,"city":29,"state":30,"zip":31,"country":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"RECRUITING","Erlangen","Bavaria","91054","Germany",{"type":34,"coordinates":35},"Point",[36,37],11.00783,49.59099,{"lat":37,"lon":36},[40,43,47,48,50],{"name":41,"role":19,"phone":20,"phoneExt":21,"email":42},"Studiensekretariat","studiensekretariat.ST@uk-erlangen.de",{"name":44,"role":19,"phone":20,"phoneExt":45,"email":46},"Benjamin Frey, MD","44248","benjamin.frey@uk-erlangen.de",{"name":14,"role":16,"phone":10,"phoneExt":10,"email":10},{"name":24,"role":49,"phone":10,"phoneExt":10,"email":10},"SUB_INVESTIGATOR",{"name":51,"role":49,"phone":10,"phoneExt":10,"email":10},"Phillip Schubert, MD",{"type":53,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100588919",false,"NCT06947668","Immune Biomarker Study for Cisplatin-ineligible Patients Receiving Chemoradiotherapy With Docetaxel","DoIT_Neck","Inclusion Criteria:\n\n* Patients with squamous cell carcinomas of the oropharynx, larynx and oral cavity for whom definitive or postoperative chemoradiation is indicated\n* Patients who are cisplatin-unfit for chemotherapy, defined as:\n\n  * ECOG 2\n  * Organ dysfunction ≥ 2 according to National Cancer Institute Common Toxicity Criteria (NCI CTC) Version 4.0, such as hearing loss or tinnitus or neurological diseases\n  * Calculated creatinine clearance of ≤50ml\u002Fmin\n  * Impaired organ function or comorbidities that preclude the use of cisplatin, e.g.: left ventricular ejection fraction \\\u003C 50%, uncorrectable renal insufficiency with elevated creatinine despite creatinine clearance of 50ml\u002Fmin due to increased body weight, uncontrolled hypertension\n  * Poor nutritional status BMI \\\u003C 16kg\u002Fm²\n  * Concomitant use of nephrotoxic drugs that cannot be discontinued or converted due to other illnesses.\n  * Willingness of patients to provide blood, saliva and stool samples and consent to the preservation of all samples for study purposes\n  * Age ≥ 18 years\n  * Sufficient cognitive abilities of the patients to understand the purpose of the study and to consent to it\n\nExclusion Criteria:\n\n* Distant metastases at the time of diagnosis and simultaneous second cancers, i.e. at the time of study inclusion\n* Malignancies in the last 5 years regardless of location (except basal cell carcinoma or cervical uteri)\n* Carcinomas in which no sample collection is possible or likely without compromising the pathological assessment\n* Persistent drug or medication abuse\n* Patients who are unwilling or unable to comply with the protocol and receive treatment\n* Patients who are unsuitable for participation in the study due to a language barrier","ALL","18 Years",{"count":63,"type":64},250,"ESTIMATED","OBSERVATIONAL","Analysis of tumor tissue (which is already available in pathology) and collection of saliva\u002Fstool and blood samples, which are obtained as part of a routine collection. These will be evaluated together with the patients' clinical data to identify possible predictors for treatment feasibility, survival, tumor control and potentially increased tumor immunogenicity by docetaxel.",[68,69,70,71],"Squamous Cell Carcinoma of Oropharynx","Squamous Cell Carcinoma of the Hypopharynx","Larynx Squamous Cell Carcinoma","Oral Cavity Squamous Cell Carcinoma","2026-03-11",{"date":74,"type":75},"2026-03-12","ACTUAL",{"date":77,"type":75},"2025-05-01",{"date":79,"type":64},"2030-12-31",{"name":5,"class":6},1]