[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100466035":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":36,"locations":42,"responsibleParty":77,"collaborators":80,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":18,"enrollmentInfo":95,"targetDuration":18,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":107,"overallStatus":45,"whyStopped":18,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"University Hospital Olomouc","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose escalation","EXPERIMENTAL","Dose escalated radiotherapy protocol: 75,9 - 79,2 Gy in 33 fractions GTV hypoxic or any hypoxic LN \\> 2cm - PTV (0mm): dose 75,9 - 79,2 Gy\u002F33 (Contours must be subtracted and reduce by 3mm in case of close relation to the skin, bones or large blood vessels) GTV primary - CTV - PTV (5+5mm): for dose 70 Gy\u002F33 LN low risk (for elective irradiation) - CTV - PTV (3mm-5mm): for dose 54 Gy\u002F33",[13],"Radiation: Dose escalation",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard fractionation","NO_INTERVENTION","Standard fractionation regimen: 70 Gy\u002F54 Gy in 33 fractions GTV primary - CTV - PTV (5+5mm): for dose 70 Gy\u002F33 GTV LN bulky (\\> 3cm) - PTV (5mm): for dose 70 Gy\u002F33 LN low risk (for elective irradiation) - CTV - PTV (3mm-5mm): for dose 54 Gy\u002F33",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"RADIATION","Dose escalation 75,9 - 79,2 Gy in 33 fractions for GTV hypoxic or any hypoxic LN \\> 2cm",[9],[25,29,33],{"name":26,"affiliation":27,"role":28},"Martin Dolezel, Prof.","Palacký University and University Hospital Olomouc","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":31,"role":32},"Marek Slavik, Ph.D.","The Masaryk Memorial Cancer Institute (MMCI)","STUDY_CHAIR",{"name":34,"affiliation":35,"role":32},"Jakub Cvek, Prof.","Faculty Hospital Ostrava",[37],{"name":38,"role":39,"phone":40,"phoneExt":18,"email":41},"Martin Dolezel, Prof","CONTACT","+420588444295","dolezelm@email.cz",[43,57,67],{"facility":44,"status":45,"city":46,"state":18,"zip":18,"country":47,"countryCode":18,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"The Masaryk Memorial Cancer Institute","RECRUITING","Brno","Czechia",{"type":49,"coordinates":50},"Point",[51,52],16.60796,49.19522,{"lat":52,"lon":51},[55],{"name":56,"role":39,"phone":18,"phoneExt":18,"email":18},"Marek Slavik, Ph.d.",{"facility":58,"status":45,"city":59,"state":18,"zip":18,"country":47,"countryCode":18,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Radiation oncology department in Palacký University and University Hospital Olomouc","Olomouc",{"type":49,"coordinates":61},[62,63],17.25175,49.59552,{"lat":63,"lon":62},[66],{"name":38,"role":39,"phone":40,"phoneExt":18,"email":41},{"facility":35,"status":45,"city":68,"state":18,"zip":18,"country":47,"countryCode":18,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Ostrava",{"type":49,"coordinates":70},[71,72],18.28204,49.83465,{"lat":72,"lon":71},[75],{"name":76,"role":39,"phone":18,"phoneExt":18,"email":18},"Jakub Cvek, Ass.Prof.",{"type":28,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Martin Dolezel","Profesor Martin Dolezel, M.D., Ph.D.",[81,83],{"name":82,"class":6},"Masaryk Memorial Cancer Institute",{"name":84,"class":6},"University Hospital Ostrava","100466035","fmiso-based-adaptive-radiotherapy-for-head-and-neck-cancer-100466035",false,"NCT05348486","FMISO-based Adaptive Radiotherapy for Head and Neck Cancer","FMISO-based Adaptive Radiotherapy for Head and Neck Cancer - a Prospective Multicenter Study","FARHEAD","Inclusion Criteria:\n\n* Pathologically proven new diagnosis of oropharyngeal p16 negative, or laryngeal, hypopharyngeal, oral cavity (independent of p16) squamous cell carcinoma of clinical stage III, IV confined to head and neck area\n* Evaluable tumor burden assessed by computed tomography scan or magnetic resonance imaging, based on RECIST (Response Evaluation Criteria in Solid Tumours) version 1.1\n* Eligibiity for definitive chemoradiation or hyperfractionated accelerated radiotherapy\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate kidney and liver function\n\nExclusion Criteria:\n\n* Prior surgical treatment - any surgery of primary tumor or involved nodes or prior surgical debulking apart from surgery with diagnostic intention (e.g. open biopsy if necessary)\n* Prior systemic therapy, targeted therapy, radiotherapy treatment for head and neck cancer\n* Cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity, such as nasopharyngeal, sinus, other para-nasal, or unknown primary head and neck cancer\n* Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis or any distant metastasis\n* Known active Hepatitis B or C\n* History of Human Immunodeficiency Virus (HIV)\n* History of a diagnosed and\u002For treated hematologic or primary solid tumor malignancy, unless in remission for at least 5 years prior to randomization\n* Previous allogeneic tissue\u002Fsolid organ transplant\n* Active infection requiring systemic therapy","ALL","18 Years",{"count":96,"type":97},120,"ESTIMATED","INTERVENTIONAL",[100],"NA","Hypoxia occurs in about 80% of head and neck tumors. Based on experimental and clinical data, hypoxia is a useful parameter for pretherapeutic stratification. These radioresistant regions can be detected with FMISO PET\u002FCT. Moreover, hypoxic subvolumes of tumors can be evolving as target volumes for radiotherapy (\"dose painting\") in hypoxia imaging-based dose escalation.",[103,104,105,106],"Head and Neck Cancer","Hypoxia","FMISO","Dose Escalation",[103,104,108,9],"Radiotherapy","2025-04-16",{"date":111,"type":112},"2025-04-22","ACTUAL",{"date":114,"type":112},"2022-04-20",{"date":116,"type":97},"2030-06-30",{"name":5,"class":6},3]