[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100481400":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":26,"responsibleParty":44,"collaborators":26,"id":47,"slug":26,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":26,"enrollmentInfo":56,"targetDuration":26,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":72,"whyStopped":26,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":26},{"fullName":5,"class":6},"Odense University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Photon therapy","ACTIVE_COMPARATOR","50-66Gy\u002F 24 fractions, inhomogeneous dose distribution Photon therapy",[13],"Radiation: Photon",{"label":15,"type":16,"description":17,"interventionNames":18},"Proton therapy","EXPERIMENTAL","50-66Gy\u002F 24 fractions, inhomogeneous dose distribution Proton therapy",[19],"Radiation: Proton",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"RADIATION","Photon","50-66Gy\u002F 24 fractions, inhomogeneous dose distribution photon therapy",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Proton","50-66Gy\u002F 24 fractions, inhomogeneous dose distribution proton therapy",[15],[32],{"name":33,"affiliation":5,"role":34},"Tine Schytte, PhD","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+4521421114","tine.schytte@rsyd.dk",{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},"Ditte S Møller, PhD","+45 61273503","Dittmoel@rm.dk",{"type":34,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Tine Schytte","Professor, Consultant","100481400",false,"NCT05548504","Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC","HERAN2 Heterogeneously Hypofractionated Radiotherapy for Locally Advanced NSCLC A Randomised Multicentre Phase II Feasibility Study","HERAN2","Inclusion Criteria:\n\n* Histological or cytological confirmed LA\\_NSCLC\n* Not candidate for definitive chemo-radiotherapy\n* Performance status 0-2\n* Signed informed consent\n* Able to comply with study and follow-up procedures\n\nExclusion Criteria:\n\n* Prior radiotherapy to the thorax unless there is no significant overlap of current treatment volumes with previous treatment fields.\n* Uncontrolled other malignant disease.\n* Pregnancy","ALL","18 Years",{"count":57,"type":58},182,"ESTIMATED","INTERVENTIONAL",[61],"PHASE2","Aim To test if proton therapy can improve survival compared to photon therapy in patients with locally advanced NSCLC who are not candidates for standard definitive chemo-radiotherapy.\n\nHypothesis The trial hypothesis is that proton therapy is less toxic than photon therapy in fragile patients and that this difference will mitigate to a difference in overall survival.\n\nDesign Multicentre, randomized phase II study 1:1 Sample size 182 patients (91 in each arm) Treatment Radiotherapy (inhomogeneous dose distribution) 50 Gy\u002F 24 fraction Endpoint Primary: Overall survival at 12 months Secondary: progression free survival, time to loco-regional and distant failure, pattern of failure, acute and late toxicity, quality of life, patient compliance.",[64,65,66],"Non-small Cell Lung Cancer Stage III","Radiotherapy Side Effect","Frailty",[68,69,70,71,66],"Locally advanced NSCLC","Radiotherapy","Randomized","Photon>\u003Cproton therapy","NOT_YET_RECRUITING","2022-09-20",{"date":75,"type":76},"2022-09-21","ACTUAL",{"date":78,"type":58},"2022-10-01",{"date":80,"type":58},"2029-09-30",{"name":5,"class":6}]