[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545603":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":39,"locations":49,"responsibleParty":104,"collaborators":106,"id":112,"slug":26,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":113,"sex":119,"minAge":120,"maxAge":26,"enrollmentInfo":121,"targetDuration":26,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":132,"overallStatus":52,"whyStopped":26,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Kantonsspital Winterthur KSW","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Hyperthermia -Experimental Group A","EXPERIMENTAL","The study arm in which hyperthermia and radiotherapy are administered. The RT Dose: 6 fractions of 5 Gy each, delivered twice per week and with a minimum interval of 48 hours, preferably 72 hours, between each fraction over three weeks.",[13,14],"Combination Product: Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined","Radiation: Radiotherapy (RT)",{"label":16,"type":17,"description":18,"interventionNames":19},"Radiotherapy - Control Group","ACTIVE_COMPARATOR","The study arm in which only radiotherapy is administered. RT Dose: 12 fractions of 4 Gy each, delivered 3 times per week, with sessions scheduled every other day (exceptions can be made in weeks with holidays) over four weeks.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"COMBINATION_PRODUCT","Water-filtered infrared-A-hyperthermia (wIRA) hyperthermia combined","The wIRA device applies hyperthermia by heating the treatment area (with maximum surface temperature set to 43° C), aiming to make cancer cells more sensitive to radiation therapy for non-melanoma skin cancer combined with radiotherapy.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"RADIATION","Radiotherapy (RT)","Radiotherapy is applied.",[9,16],[33,37],{"name":34,"affiliation":35,"role":36},"Winfried Arnold, Dr.med.univ.(A)","Luzerner Kantonsspital","PRINCIPAL_INVESTIGATOR",{"name":38,"affiliation":35,"role":36},"Maximilian Sturz, Dr.med.",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":26,"email":44},"Nidar Batifi, MSc","CONTACT","+41522665361","sahara-team@ksw.ch",{"name":46,"role":42,"phone":47,"phoneExt":26,"email":48},"Daniel Zwahlen, Prof. Dr. med.","+4152 266 26 53","radioonkologie@ksw.ch",[50,66,81,94],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Kantonsspital Aarau","RECRUITING","Aarau","Canton of Aargau","5001","Switzerland",{"type":58,"coordinates":59},"Point",[60,61],8.04422,47.39254,{"lat":61,"lon":60},[64],{"name":65,"role":42,"phone":26,"phoneExt":26,"email":26},"Emsad Puric, Dr. med.",{"facility":67,"status":52,"city":68,"state":69,"zip":70,"country":56,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Kantonsspital Winterthur","Winterthur","Canton of Zurich","8401",{"type":58,"coordinates":72},[73,74],8.72413,47.50564,{"lat":74,"lon":73},[77,79],{"name":41,"role":42,"phone":26,"phoneExt":26,"email":78},"study-coordination-radiotherapy@ksw.ch",{"name":80,"role":36,"phone":26,"phoneExt":26,"email":26},"Stefan Brodmann, Dr.med.",{"facility":82,"status":52,"city":83,"state":26,"zip":84,"country":56,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Lindenhofgruppe","Bern","3001",{"type":58,"coordinates":86},[87,88],7.44744,46.94809,{"lat":88,"lon":87},[91],{"name":92,"role":42,"phone":93,"phoneExt":26,"email":26},"Markus Notter, Dr. med.","+41 31 300 95 11",{"facility":35,"status":52,"city":95,"state":26,"zip":96,"country":56,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Lucerne","6000",{"type":58,"coordinates":98},[99,100],8.30635,47.05048,{"lat":100,"lon":99},[103],{"name":34,"role":42,"phone":26,"phoneExt":26,"email":26},{"type":105,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[107,108,111],{"name":35,"class":6},{"name":109,"class":110},"Lindenhofgruppe AG","INDUSTRY",{"name":51,"class":6},"100545603",false,"NCT06384053","Skin Cancer and Hyperthermia and Radiotherapy","Skin Cancer and Hyperthermia and Radiotherapy - SAHARA a Two-arm, Open-label, Randomized Controlled Phase II Trial","SAHARA","Inclusion Criteria:\n\n* Personally signed and dated written informed consent\n* Histologically confirmed invasive non-melanoma skin cancer (NMSC), including basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) of any differentiation\n* ≥ T2 (TNM Classification 8th Edition)\n* Tumor thickness up to 2cm (Maximum Depth invasion and\u002For exophytic growth, measured on pathology report or imaging)\n* Local recurrence allowed, if primary treatment longer ago than 6 months (after primary treatment other than radiotherapy (RT))\n* Age ≥ 65 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2, with a life expectancy of more than 6 months\n* Presentation at the Swiss Hyperthermia Network (SHN) tumor conference mandatory\n\nExclusion Criteria:\n\n* Other histology than BCC or SCC\n* T1 tumor and\u002For N+ (according to TNM classification 8th edition)\n* Tumors after resection (R1 or R2 as well as adjuvant indication)\n* Tumor invasion into critical areas\n* Several lesions exceeding the capacity of one treatment\u002Fradiation field (multiple lesions within one treatment field are acceptable)\n* Previous (one month) or concurrent Chemo- or Immunotherapy\n* Patients with connective tissue disorders (e.g. Sclerodermia, Lupus erythematodes)\n* Lesions inside or in proximity (within 3cm) previously irradiated area\n* Medical immunosuppression\n* wIRA-specific exclusion criteria\n\n  * Tattoos in irradiated area\n  * Increased photosensitivity (either due to simultaneous treatment with photosensitivity-enhancing medications or conditions such as porphyria)","ALL","65 Years",{"count":122,"type":123},100,"ESTIMATED","INTERVENTIONAL",[126],"NA","The SAHARA trial assesses wether combining ultrahypofractionated accelerated radiotherapy (RT) with hyperthermia is as effective as standard hypofractionated high-dose radiation in treating non-melanoma skin cancer (NMSC).",[129,130,131],"Basal Cell Carcinoma","Squamous Cell Carcinoma Skin","Non-melanoma Skin Cancer",[133,134,135,136,137,138,139],"BCC","SCC skin","w-IRA hyperthermia","radiotherapy for non-melanoma skin cancer","non-melanoma Skin cancer","w-IRA combined with RT","hyperthermia","2025-06-11",{"date":142,"type":143},"2025-06-15","ACTUAL",{"date":145,"type":143},"2025-01-01",{"date":147,"type":123},"2028-07-01",{"name":5,"class":6},4]