[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553539":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":55,"collaborators":25,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":25,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":25,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"University Health Network, Toronto","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Integrated Boost Radiotherapy","ACTIVE_COMPARATOR","External beam radiotherapy 70Gy in 35 fractions to head and neck tumour and 56 Gy in 35 fraction to elective nodal regions. This will be given as single integrated boost or two-phase treatment at clinician discretion.",[13],"Radiation: Standard of care external beam radiotherapy (single integrated boost)",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm 2: Two Phase Radiotherapy","Standard of care external beam radiotherapy 70 Gy in 35 fractions to head and neck with delayed 40 Gy in 20 fractions (HPV+ oropharynx) or 50 Gy\u002F25 (all other disease) to elective nodal regions. This will be given as reversed two-phase treatment.",[18],"Radiation: Standard of care external beam radiotherapy (two-phase treatment)",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"RADIATION","Standard of care external beam radiotherapy (single integrated boost)","70Gy in 35 fractions, 56 Gy in 35 fractions. Oral Pimonidazole 200 mg and 300 mg tablets.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Standard of care external beam radiotherapy (two-phase treatment)","70Gy in 35 fractions, delayed 40 Gy in 20 fractions or 50 Gy in 25 fractions. Oral Pimonidazole 200 mg and 300 mg tablets.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Andrew McPartlin, MD","CONTACT","416-946-2132","andrew.mcpartlin@rmp.uhn.ca",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Princess Margaret Cancer Centre","RECRUITING","Toronto","Ontario","M5G 2M9","Canada","CA",{"type":46,"coordinates":47},"Point",[48,49],-79.39864,43.70643,{"lat":49,"lon":48},[52],{"name":32,"role":33,"phone":53,"phoneExt":25,"email":54},"(416) 946-4501 x 4855","andrew.mcpartlin@uhn.ca",{"type":56,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100553539","hn-bio-02-a-phase-ii-randomized-study-of-the-effects-of-delayed-elective-radiotherapy-on-head-and-neck-mri-and-immune-response-biomarkers-100553539",false,"NCT06487403","HN-BIO 02: A Phase II Randomized Study of the Effects of Delayed Elective Radiotherapy on Head and Neck MRI and Immune Response Biomarkers","HN-Bio 02","Inclusion Criteria:\n\n* Age \\>\u002F= 18 years\n* Histologically proven Head and Neck Squamous Cell carcinoma\n* Primary or nodal disease \\> 3cm for biomarker imaging\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2\n* Planned for curative surgery or (chemo)radiotherapy\n* Willingness to undergo repeat MRI imaging\n* Able to receive and understand verbal and written information regarding study and able to -give written informed consent\n* Adequate renal function: Calculated creatinine clearance \\>\u002F= 30ml\u002Fmin\n* Be able to lie comfortably on back for 1 hour\n\nExclusion Criteria:\n\n* As judged by investigator evidence of systemic disease that makes unsuitable for study\n* Contra-indication for serial MRI scans\n* Previous solid tumor treated within last 5 years\n* Pregnancy\n* History of gadolinium contrast allergy\n* Non-reversible clotting abnormality","ALL","18 Years",{"count":67,"type":68},40,"ESTIMATED","INTERVENTIONAL",[71],"NA","This is a single centre prospective exploratory study of effects of radiation therapy on biomarker development in patients with newly diagnosed (head and neck squamous cell carcinoma) HNSCC receiving curative therapy. This research is part 2 of the HN-BIO study.",[74],"Squamous Cell Carcinoma of Head and Neck","2026-03-03",{"date":77,"type":78},"2026-03-04","ACTUAL",{"date":80,"type":78},"2025-04-17",{"date":82,"type":68},"2028-08-01",{"name":5,"class":6},1]