[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646499":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":37,"centralContacts":41,"locations":49,"responsibleParty":64,"collaborators":67,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":32,"enrollmentInfo":83,"targetDuration":32,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":98,"overallStatus":106,"whyStopped":32,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Erasmus Medical Center","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Thermotherapy adjuvant to chemoradiotherapy","EXPERIMENTAL","This primary cohort will consist of patients recieving thermotherapy adjuvant to standard chemoradiotherapy for LAHNC. Dose-escalation is performed in this cohort.",[13,14],"Other: Thermotherapy","Radiation: Concurrent chemoradiation",{"label":16,"type":10,"description":17,"interventionNames":18},"Thermotherpy adjuvant to radiotherapy monotherapy","This parallel cohort will consist of patients recieving thermotherapy adjuvant to standard radiotherapy monotherapy for LAHNC. Prospective registration of safety and tolerability is performed in this cohort.",[13,19],"Radiation: Radiotherapy",[21,27,33],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Thermotherapy","Patients will receive thermotherapy once weekly, adjuvant to standard of care (chemo)radiotherapy.",[9,16],[26],"Hyperthermia",{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"RADIATION","Radiotherapy","Standard of care radiotherapy, often 70 Gy in 35 daily fractions, 5 times per week.",[16],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Concurrent chemoradiation","Standard of care chemoradiotherapy, 70 Gy in 35 daily fractions, 5 times per week with concurrent platinum based chemotherapy (cisplatin or carboplatin).",[9],[38],{"name":39,"affiliation":5,"role":40},"Michiel Kroesen, MD, Dr.","PRINCIPAL_INVESTIGATOR",[42,46],{"name":39,"role":43,"phone":44,"phoneExt":32,"email":45},"CONTACT","+31107041116","m.kroesen@erasmusmc.nl",{"name":47,"role":43,"phone":44,"phoneExt":32,"email":48},"Tessa L. Coenraad, MSc","t.coenraad@erasmusmc.nl",[50],{"facility":5,"status":32,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Rotterdam","South Holland","3015 CD","Netherlands","NL",{"type":57,"coordinates":58},"Point",[59,60],4.47917,51.9225,{"lat":60,"lon":59},[63],{"name":39,"role":43,"phone":44,"phoneExt":32,"email":45},{"type":40,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Michiel Kroesen","Radiation Oncologist",[68,70],{"name":69,"class":6},"Dutch Cancer Society",{"name":71,"class":72},"Sensius BV","UNKNOWN","100646499","phase-1-thermotherapy-for-head-and-neck-cancer-patients-100646499",false,"NCT07690618","Thermotherapy for Head and Neck Cancer Patients","Thermotherapy for Locally Advanced Head and Neck Cancer Patients in Primary Setting - a Phase I Dose-finding Study","TANCAP-I","For eligibility to participate in this study in the primary cohort, a patient must meet all following criteria:\n\n* Age ≥ 18 years\n* WHO 0-1\n* Maximal mouth opening of ≥ 40 mm for women and ≥ 45 mm for men before treatment\n* Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx and larynx proven by cytology\u002Fhistology\n* Locally advanced disease (stage III-IV)\n* Curative intent treatment with radiotherapy and concurrent platinum based chemotherapy in primary setting\n* Ability to understand the requirements of the study and to give written informed consent, as determined by the treating physician\n* Written informed consent\n\nFor the parallel secondary cohort, the same inclusion criteria must be met, except for the standard of care treatment:\n\n* Curative intent treatment with radiotherapy monotherapy in primary setting\n\nExclusion criteria for either cohort:\n\n* Patients previously treated by radiation on the same target volume.\n* Any condition or circumstance potentially hampering compliance with the follow-up schedule.","ALL","18 Years",{"count":84,"type":85},30,"ESTIMATED","INTERVENTIONAL",[88],"PHASE1","This phase I, single-center study evaluates the safety, tolerability, and recommended phase II dose (RP2D) of mild hyperthermia (thermotherapy) when added to standard-of-care treatment in patients with locally advanced head and neck squamous cell carcinoma (LAHNSCC). Tumor recurrence remains common despite chemoradiotherapy, highlighting the need for treatment intensification. Thermotherapy, which increases tumor temperature to 39-45°C, may enhance the effect of the treatment.\n\nThe study consists of two components: (1) a dose-escalation cohort in patients receiving definitive chemoradiotherapy, using a Time-to-Event Bayesian Optimal Interval (TiTE-BOIN) design to determine the RP2D based on dose-limiting toxicities (DLTs) and treatment tolerability; and (2) a parallel cohort of patients receiving radiotherapy alone, in whom thermotherapy is administered at dose levels previously shown to be safe and tolerable in the chemoradiotherapy cohort to evaluate tolerability in this patient population.\n\nBesides the safety and tolerability of the thermotherapy RP2D, the secondary objectives include evaluation of safety in patients receiving radiotherapy alone, as well as exploratory assessment of tumor control and survival outcomes.\n\nThis study aims to support the development of safe and feasible thermotherapy-based treatment strategies to improve locoregional control and outcomes in patients with LAHNSCC.",[91,92,93,94,95,96,97],"Head and Neck Cancer","Oropharyngeal Carcinoma","Hypopharyngeal Carcinoma","Laryngeal Carcinoma","Head and Neck Squamous Cell Carcinoma","Oral Cavity Carcinoma","Locally Advanced Head and Neck Carcinoma",[26,22,99,100,101,102,103,104,105],"Phase 1 trial","Chemoradiotherapy","Radiosensitization","Safety","Tolerability","Locoregional Control","Locally advanced cancer","NOT_YET_RECRUITING","2026-07-01",{"date":109,"type":110},"2026-07-08","ACTUAL",{"date":112,"type":85},"2026-08-01",{"date":114,"type":85},"2031-11",{"name":5,"class":6},1]