[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100430796":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":31,"responsibleParty":47,"collaborators":20,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":20,"enrollmentInfo":59,"targetDuration":20,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":77,"overallStatus":82,"whyStopped":20,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Charite University, Berlin, Germany","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Hyperthermia","EXPERIMENTAL","Patients will receive 6-8 treatments additional loco-regional hyperthermia concurrent to re-irradiation. Hyperthermia will start on the third day of fractionated radiotherapy and will be given twice per week. According to site of recurrent disease either deep-regional, capacitive or superficial hyperthermia devices may be used.",[13],"Device: loco-regional hyperthermia",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","loco-regional hyperthermia","loco-regional hyperthermia by the use of microwave, capacitive, or superficial hyperthermia devices.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Sebastian Zschaeck, MD","Charité","PRINCIPAL_INVESTIGATOR",[27],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","+4930450650764","sebastian.zschaeck@charite.de",[32],{"facility":33,"status":20,"city":34,"state":20,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Klinik für Radioonkologie und Strahlentherapie","Berlin","13353","Germany","DE",{"type":39,"coordinates":40},"Point",[41,42],13.41053,52.52437,{"lat":42,"lon":41},[45],{"name":46,"role":28,"phone":20,"phoneExt":20,"email":20},"Sebastian Zschaeck, M.D.",{"type":25,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Sebastian Zschaeck","MD, PI","100430796","phase-2-hyperthermia-enhanced-re-irradiation-of-loco-regional-recurrent-tumors-100430796",false,"NCT04889742","Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors","HETERERO","Inclusion Criteria:\n\n* prior radiotherapy of the treatment side with a treatment dose \\> 30 Gray (Gy) EQD2 (calculated with alpha\u002Fbeta value of 9)\n* local\u002F regional \u002F or oligometastatic tumor recurrence. Maximum number of three macroscopic tumor lesions with at least one of them receiving prior radiotherapy\n* macroscopic tumor recurrence\n* side of recurrence is amenable to hyperthermia (abdomen, pelvis, extremities, spine, cervical lymphnodes)\n* planned re-irradiation dose of at least 40 Gy EQD2 (calculated with alpha\u002Fbeta value of 9)\n\nExclusion Criteria:\n\n* \\>3 macroscopic tumor lesion\n* brain metastases\n* recurrence is amenable to local ablative radiotherapy (brachytherapy or stereotactic radiotherapy)\n* recurrence region is not amenable to hyperthermia (lung, liver, mediastinum)\n* contraindications for hyperthermia (serious cariovascular disease, ICD or larger implants at the treatment site)\n* psychiatric disorders that impede proper informed consent\n* serious comorbidities with very limited prognosis quo ad vitam","ALL","18 Years",{"count":60,"type":61},110,"ESTIMATED","INTERVENTIONAL",[64],"PHASE2","This study investiagates deep-regional or superficial hyperthermia to enhance radiotherapy or chemoradiation in patients that suffer recurrent disease after previous radiotherapy.",[67,68,69,70,71,72,73,74,75,76],"Recurrent Cancer","Prostate Cancer","Cervical Cancer","Anal Cancer","Sarcoma","Rectal Cancer","Neuroendocrine Tumors","Esophageal Cancer","Pancreas Cancer","Squamous Cell Carcinoma",[78,79,80,81],"re-irradiation","hyperthermia","local recurrence","hyperthermic","NOT_YET_RECRUITING","2023-12-19",{"date":85,"type":86},"2023-12-26","ACTUAL",{"date":88,"type":61},"2024-05-10",{"date":90,"type":61},"2028-01",{"name":5,"class":6},1]