[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100316219":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":43,"centralContacts":48,"locations":56,"responsibleParty":216,"collaborators":219,"id":229,"slug":230,"hasResults":231,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":231,"sex":237,"minAge":238,"maxAge":34,"enrollmentInfo":239,"targetDuration":34,"studyType":242,"phases":243,"briefSummary":245,"conditions":246,"keywords":248,"overallStatus":59,"whyStopped":34,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":265},{"fullName":5,"class":6},"Technische Universität Dresden","OTHER",[8,14,19,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Interventional Arm A - HPV(+)","EXPERIMENTAL","De-escalation Radio(chemo)therapy - Level 1",[13],"Radiation: De-escalation radio(chemo)therapy - Level 1",{"label":15,"type":10,"description":16,"interventionNames":17},"Interventional Arm B - HPV(+)","De-escalation Radio(chemo)therapy - Level 2",[18],"Radiation: De-escalation radio(chemo)therapy - Level 2",{"label":20,"type":21,"description":22,"interventionNames":23},"Observational Arm A - HPV(-)","ACTIVE_COMPARATOR","Standard Radio(chemo)therapy",[24],"Radiation: Standard radio(chemotherapy)",{"label":26,"type":21,"description":22,"interventionNames":27},"Observational Arm B - HPV(+)",[24],[29,35,39],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"RADIATION","De-escalation radio(chemo)therapy - Level 1","55\u002F 59,4 Gy (intermediate \u002F high risk group)",[9],null,{"type":30,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"De-escalation radio(chemo)therapy - Level 2","48,4\u002F 55 Gy (intermediate \u002F high risk group)",[15],{"type":30,"name":40,"description":41,"armGroupLabels":42,"otherNames":34},"Standard radio(chemotherapy)","60\u002F 66 Gy (intermediate \u002F high risk group)",[20,26],[44],{"name":45,"affiliation":46,"role":47},"Mechthild Krause, Prof.","University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology, German Consortium for Translational Cancer Research (DKTK)","STUDY_CHAIR",[49,53],{"name":45,"role":50,"phone":51,"phoneExt":34,"email":52},"CONTACT","+49 351 458 2238","mechthild.krause@uniklinikum-dresden.de",{"name":54,"role":50,"phone":51,"phoneExt":34,"email":55},"Fabian Lohaus, MD","fabian.lohaus@uniklinikum-dresden.de",[57,79,96,110,127,143,158,174,188,199],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"University Clinic Tübingen","RECRUITING","Tübingen","Baden-Wurttemberg","72016","Germany","DE",{"type":66,"coordinates":67},"Point",[68,69],9.05222,48.52266,{"lat":69,"lon":68},[72,76],{"name":73,"role":50,"phone":74,"phoneExt":34,"email":75},"Maximilian Niyazi, Prof.","07071 29-82165","ROInfo@med.uni-tuebingen.de",{"name":77,"role":78,"phone":34,"phoneExt":34,"email":34},"Simon Böke, Dr","PRINCIPAL_INVESTIGATOR",{"facility":80,"status":59,"city":81,"state":82,"zip":83,"country":63,"countryCode":64,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"University Clinic Essen","Essen","North Rhine-Westphalia","45147",{"type":66,"coordinates":85},[86,87],7.01228,51.45657,{"lat":87,"lon":86},[90,92,94],{"name":91,"role":50,"phone":34,"phoneExt":34,"email":34},"Martin Stuschke, Prof. Dr.",{"name":34,"role":50,"phone":34,"phoneExt":34,"email":93},"Maja.guberina@uk-essen.de",{"name":95,"role":78,"phone":34,"phoneExt":34,"email":34},"Maja Guberina, PD Dr.",{"facility":97,"status":59,"city":98,"state":99,"zip":100,"country":63,"countryCode":64,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"University Clinic Dresden","Dresden","Saxony","01307",{"type":66,"coordinates":102},[103,104],13.73832,51.05089,{"lat":104,"lon":103},[107],{"name":45,"role":50,"phone":108,"phoneExt":34,"email":109},"+493514582238","str.studien@uniklinikum-dresden.de",{"facility":111,"status":112,"city":113,"state":34,"zip":114,"country":63,"countryCode":64,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Charité - Universitätsmedizin Berlin","NOT_YET_RECRUITING","Berlin","13353",{"type":66,"coordinates":116},[117,118],13.41053,52.52437,{"lat":118,"lon":117},[121,123,125],{"name":122,"role":50,"phone":34,"phoneExt":34,"email":34},"Daniel Zips, Prof.",{"name":34,"role":50,"phone":34,"phoneExt":34,"email":124},"marcus.beck@charite.de",{"name":126,"role":78,"phone":34,"phoneExt":34,"email":34},"Beck Marcus, Dr. med.",{"facility":128,"status":59,"city":129,"state":34,"zip":130,"country":63,"countryCode":64,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"University Clinic Frankfurt","Frankfurt am Main","60590",{"type":66,"coordinates":132},[133,134],8.68417,50.11552,{"lat":134,"lon":133},[137,139,141],{"name":138,"role":50,"phone":34,"phoneExt":34,"email":34},"Claus Rödel, Prof. Dr.",{"name":34,"role":50,"phone":34,"phoneExt":34,"email":140},"Fleischmann@med.uni-frankfurt.de",{"name":142,"role":78,"phone":34,"phoneExt":34,"email":34},"Maximilian Fleischmann, Dr.",{"facility":144,"status":59,"city":145,"state":34,"zip":146,"country":63,"countryCode":64,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"University Clinic Freiburg","Freiburg im Breisgau","79106",{"type":66,"coordinates":148},[149,150],7.85222,47.9959,{"lat":150,"lon":149},[153,156],{"name":154,"role":50,"phone":34,"phoneExt":34,"email":155},"Anca-Ligia Grosu, Prof. Dr.","anca.grosu@uniklinik-freiburg.de",{"name":157,"role":78,"phone":34,"phoneExt":34,"email":34},"Ana-Ligia Grosu, Prof. Dr.",{"facility":159,"status":59,"city":160,"state":34,"zip":161,"country":63,"countryCode":64,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"University Clinic Heidelberg","Heidelberg","69120",{"type":66,"coordinates":163},[164,165],8.69079,49.40768,{"lat":165,"lon":164},[168,170,172],{"name":169,"role":50,"phone":34,"phoneExt":34,"email":34},"Jürgen Debus, Prof. Dr.",{"name":34,"role":50,"phone":34,"phoneExt":34,"email":171},"Thomas.Held@med.uni-heidelberg.de",{"name":173,"role":78,"phone":34,"phoneExt":34,"email":34},"Thomas Held, PD Dr.",{"facility":175,"status":59,"city":176,"state":34,"zip":177,"country":63,"countryCode":64,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"LMU Munich University Hospital","München","81377",{"type":66,"coordinates":179},[180,181],13.31243,51.60698,{"lat":181,"lon":180},[184,187],{"name":185,"role":50,"phone":34,"phoneExt":34,"email":186},"Claus Belka, Prof. Dr.","Claus.Belka@med.uni-muenchen.de",{"name":185,"role":78,"phone":34,"phoneExt":34,"email":34},{"facility":189,"status":59,"city":176,"state":34,"zip":190,"country":63,"countryCode":64,"cosmosGeoPoint":191,"geoPoint":193,"contacts":194},"TUM University Hospital","81675",{"type":66,"coordinates":192},[180,181],{"lat":181,"lon":180},[195,198],{"name":196,"role":50,"phone":34,"phoneExt":34,"email":197},"Stephanie Combs, Prof. Dr.","radonk@lrz.tum.de",{"name":196,"role":78,"phone":34,"phoneExt":34,"email":34},{"facility":200,"status":59,"city":201,"state":34,"zip":202,"country":63,"countryCode":64,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"University Clinic Regensburg","Regensburg","93053",{"type":66,"coordinates":204},[205,206],12.10161,49.01513,{"lat":206,"lon":205},[209,212,214],{"name":210,"role":50,"phone":34,"phoneExt":34,"email":211},"Oliver Kölbl, Prof. Dr.","oliver.koelbl@ukr.de",{"name":34,"role":50,"phone":34,"phoneExt":34,"email":213},"f.steger@ukr.de",{"name":215,"role":78,"phone":34,"phoneExt":34,"email":34},"Felix Steger, Dr.",{"type":78,"investigatorFullName":217,"investigatorTitle":218,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Mechthild Krause","Director of the Department of Radiotherapy and Radiation Oncology",[220,222,225,227],{"name":221,"class":6},"German Cancer Research Center",{"name":223,"class":224},"National Center for Tumor Diseases (NCT) Dresden","UNKNOWN",{"name":226,"class":6},"National Center for Tumor Diseases, Heidelberg",{"name":228,"class":6},"Radiation Oncology Working Group of the German Cancer Society","100316219","de-escalation-of-adjuvant-radio-chemo-therapy-for-hpv-positive-head-neck-squamous-cell-carcinomas-100316219",false,"NCT03396718","De-escalation of Adjuvant Radio (Chemo) Therapy for HPV-positive Head-neck Squamous Cell Carcinomas","De-escalation of Adjuvant Radio (Chemo) Therapy for HPV-positive Head and Neck Squamous Cell Carcinomas: A Phase I Study to Reduce Late Toxicity","DELPHI","Inclusion Criteria:\n\n* Condition after surgical removal of a squamous cell carcinoma of the oropharynx and adequate lymph node dissection\n* Indication for adjuvant radiotherapy or radiochemotherapy in the interdisciplinary tumor board\n* Good general state (ECOG performance status 0 or 1)\n* Adequate compliance to ensure closely follow-up\n* Patient's consent and written consent\n* Neck dissection of at least the tumor bearing side\n\nAdditional Inclusion Criteria Arm intermediate risk (at least one of the criteria must be fulfilled):\n\n* pT3 and R0 and \u002F or\n* histologically confirmed involvement of lymph nodes (n = 1-3) and no extracapsular extension of the lymph node metastasis\n\nAdditional Inclusion Criteria Arm high risk (at least one of the criteria must be fulfilled):\n\n* residual tumor (R1 status) and \u002F or\n* pathologic stage T4 (pT4) status and \u002F or\n* more than 3 infected lymph nodes and \u002F or\n* extracapsular extension of at least one lymph node metastasis\n\nExclusion Criteria:\n\n* Patients with a cumulative nicotine abuse \\> 30 packyears. These patients are not included in the intervention arms, but are always included in the observation arms (regardless of HPV status).\n* radiologically presumed or histologically confirmed distant metastasis\n* R2 resection or macroscopically visible residual tumor after surgery\n* no neck dissection\n* interval between last operation and planned irradiation start \\> 7 weeks\n* contraindication against a guideline-appropriate adjuvant radiation or radiochemotherapy according to the clinical risk constellation\n* tumor disease in the last five years before the beginning of the study (except basaliomas of the skin, in-situ carcinoma of the cervix uteri or breast, or tumors with similar prognosis which are considered to be very likely to be cured)\n* malignant tumor disease in the head and neck region, regardless of interval and prognosis\n* Pre-irradiation with risk of dose overlap\n* participation in another clinical trial if further experimental therapy is necessary or the treatments\u002F protocols are mutually exclusive (e.g. altered chemotherapy, additional consolidation chemotherapy). Allowed is the additional participation in observation studies or supportive therapy studies.\n* diseases or conditions which do not allow the person concerned to assess the nature and scope and possible consequences of the clinical trial\n* pregnant or lactating women\n* evidence that the participant is not expected to comply with the study protocol (e.g. lack of cooperation)\n* missing written consent","ALL","18 Years",{"count":240,"type":241},304,"ESTIMATED","INTERVENTIONAL",[244],"NA","In patients with squamous cell carcinoma of the oral cavity, the oropharynx and larynx with local advanced tumors (pathologic stage T3 = pT3) and or lymph node involvement (pN+) postoperative radio - or radiochemotherapy is the standard of care. Postoperative radiochemotherapy is indicated in patients with multiple lymph node metastasis, lymph node metastasis with extracapsular spread and \u002F or residual tumor (R1-Status) after resection. Oropharyngeal cancer caused by HPV (human papillomavirus 16) is a distinct subgroup with a known sensitivity to radiotherapy (RTx) or radiochemotherapy (RCTx). Additionally a superior outcome after R(C)Tx over HPV negative patients was shown for patients treated with primary or adjuvant RCTx. To date it is unknown if the total dose of the radiotherapy can be safely reduced with the aim to decrease the therapy associated late effects.\n\nPatients with a HPV associated carcinoma that take part in the study will be treated with a reduced radiotherapy dose, chemotherapy will be prescribed based on clinical factors (number of affected lymph node, presence of extracapsular spread or residual tumor). Radiation dose will be reduced in two steps.",[247],"Head-and-neck Squamous Cell Carcinoma",[249,250,251,252,253,254,255],"Head and neck cancer","Oropharyngeal cancer","postoperative","radiotherapy","radiochemotherapy","de-intensification","HPV","2025-09-16",{"date":258,"type":259},"2025-09-22","ACTUAL",{"date":261,"type":259},"2018-11-29",{"date":263,"type":241},"2032-11-30",{"name":5,"class":6},10]