[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545603":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":39,"locations":49,"responsibleParty":105,"collaborators":107,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":115,"sex":121,"minAge":122,"maxAge":26,"enrollmentInfo":123,"targetDuration":26,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":134,"overallStatus":52,"whyStopped":26,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"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",[50,67,82,95],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Kantonsspital Aarau","RECRUITING","Aarau","Canton of Aargau","5001","Switzerland","CH",{"type":59,"coordinates":60},"Point",[61,62],8.04422,47.39254,{"lat":62,"lon":61},[65],{"name":66,"role":42,"phone":26,"phoneExt":26,"email":26},"Emsad Puric, Dr. med.",{"facility":68,"status":52,"city":69,"state":70,"zip":71,"country":56,"countryCode":57,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Kantonsspital Winterthur","Winterthur","Canton of Zurich","8401",{"type":59,"coordinates":73},[74,75],8.72413,47.50564,{"lat":75,"lon":74},[78,80],{"name":41,"role":42,"phone":26,"phoneExt":26,"email":79},"study-coordination-radiotherapy@ksw.ch",{"name":81,"role":36,"phone":26,"phoneExt":26,"email":26},"Stefan Brodmann, Dr.med.",{"facility":83,"status":52,"city":84,"state":26,"zip":85,"country":56,"countryCode":57,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Lindenhofgruppe","Bern","3001",{"type":59,"coordinates":87},[88,89],7.44744,46.94809,{"lat":89,"lon":88},[92],{"name":93,"role":42,"phone":94,"phoneExt":26,"email":26},"Markus Notter, Dr. med.","+41 31 300 95 11",{"facility":35,"status":52,"city":96,"state":26,"zip":97,"country":56,"countryCode":57,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Lucerne","6000",{"type":59,"coordinates":99},[100,101],8.30635,47.05048,{"lat":101,"lon":100},[104],{"name":34,"role":42,"phone":26,"phoneExt":26,"email":26},{"type":106,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[108,109,112],{"name":35,"class":6},{"name":110,"class":111},"Lindenhofgruppe AG","INDUSTRY",{"name":51,"class":6},"100545603","skin-cancer-and-hyperthermia-and-radiotherapy-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":124,"type":125},100,"ESTIMATED","INTERVENTIONAL",[128],"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).",[131,132,133],"Basal Cell Carcinoma","Squamous Cell Carcinoma Skin","Non-melanoma Skin Cancer",[135,136,137,138,139,140,141],"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":144,"type":145},"2025-06-15","ACTUAL",{"date":147,"type":145},"2025-01-01",{"date":149,"type":125},"2028-07-01",{"name":5,"class":6},4]