[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100376780":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":42,"responsibleParty":72,"collaborators":26,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":26,"enrollmentInfo":86,"targetDuration":26,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":26,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University Hospital Heidelberg","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"C12 irradiation","EXPERIMENTAL","Evaluation of Safety and Toxicity of C12 ion reirradiation",[13],"Radiation: C12 re-irradiation",{"label":15,"type":16,"description":17,"interventionNames":18},"Photon irradiation","ACTIVE_COMPARATOR","Evaluation of Safety and Toxicity of photon re-irradiation",[19],"Radiation: Photon re-irradiation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"RADIATION","C12 re-irradiation","51 Gy(RBE) or 54 Gy",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Photon re-irradiation","54 Gy(RBE) or 60 Gy",[15],[32,38],{"name":33,"role":34,"phone":35,"phoneExt":36,"email":37},"Held Thomas, PD Dr.","CONTACT","49 622156","8202","thomas.held@med.uni-heidelberg.de",{"name":39,"role":34,"phone":35,"phoneExt":40,"email":41},"Cornelia Jäkel, Dr.","34091","studienkoordination.rad@med.uni-heidelberg.de",[43,60],{"facility":44,"status":45,"city":46,"state":26,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"University Hospital of Heidelberg, Radiation Oncology","RECRUITING","Heidelberg","69120","Germany","DE",{"type":51,"coordinates":52},"Point",[53,54],8.69079,49.40768,{"lat":54,"lon":53},[57,59],{"name":33,"role":34,"phone":58,"phoneExt":36,"email":37},"+49-6221-56",{"name":39,"role":34,"phone":58,"phoneExt":40,"email":41},{"facility":61,"status":45,"city":62,"state":26,"zip":63,"country":48,"countryCode":49,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Philips University Marburg","Marburg","35037",{"type":51,"coordinates":65},[66,67],8.77069,50.80904,{"lat":67,"lon":66},[70],{"name":71,"role":34,"phone":26,"phoneExt":26,"email":26},"Sebastian Adeberg, Prof. Dr.",{"type":73,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Juergen Debus","Head of department","100376780","carbon-ion-re-radiotherapy-in-patients-with-recurrent-or-progressive-locally-advanced-head-and-neck-cancer-100376780",false,"NCT04185974","Carbon Ion Re-Radiotherapy in Patients With Recurrent or Progressive Locally Advanced Head-and-Neck Cancer","Carbon Ion Re-Radiotherapy in Patients With Recurrent or Progressive Locally Advanced Head-and-Neck Cancer: A Phase-II Study to Evaluate Toxicity and Efficacy","CARE","Inclusion Criteria:\n\n* Locally recurrent \u002F progressive head-and-neck cancer after initial radiation therapy\n* Microscopic or macroscopic tumor after salvage surgery\n* Indication for re-irradiation\n* Completed wound healing after surgical intervention\n* Karnofsky-Performance-Score ≥ 60\n* Age ≥ 18 years\n* Written informed consent (must be available before enrolment in the trial)\n* Ability of subject to understand character and individual consequences of the trial\n* For women with childbearing potential, (and men) adequate contraception\n* Submission of previous radiotherapy records\n\nExclusion Criteria:\n\n* Re-irradiation of malignancy in the larynx\n* Diagnosed plasmocytoma, sarcoma or chordoma\n* Previous re-irradiation in-field\n* Time interval \\\u003C 6 months after initial radiotherapy\n* Distant metastases (except pulmonary metastases)\n* Patients who have not recovered from acute toxicities of prior therapies\n* Refusal of the patients to take part in the study\n* Pregnant or lactating women\n* Known carcinoma \\\u003C5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy\n* Participation in another clinical study or observation period of competing trials, respectively","ALL","18 Years",{"count":87,"type":88},72,"ESTIMATED","INTERVENTIONAL",[91],"NA","After multimodal therapy of head-and-neck tumors, patients often develop local recurrence, locally progressive disease or second primary tumors. In this highly pre-treated patient cohort, therapeutic options are limited. Patients that are not candidates for salvage surgery may benefit from re-irradiation. Despite recent technical advances, re-irradiation is associated with severe side effects. Carbon ion Re-Radiotherapy (reCIRT) has shown encouraging results in retrospective analyses with moderate toxicity.\n\nIn the current Phase-II CARE-trial, reCIRT and conventional photon re-irradiation in patients with recurrent or progressive locally advanced head-and-neck cancer will be assessed regarding toxicity\u002F safety, local progression-free survival, overall survival and quality-of-life.",[94],"Locally Advanced Head-and-Neck Cancer","2026-03-21",{"date":97,"type":98},"2026-03-25","ACTUAL",{"date":100,"type":98},"2020-08-25",{"date":102,"type":88},"2031-01-30",{"name":5,"class":6},2]