[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100335563":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":34,"centralContacts":39,"locations":44,"responsibleParty":88,"collaborators":11,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":92,"sex":98,"minAge":99,"maxAge":11,"enrollmentInfo":100,"targetDuration":11,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":11,"overallStatus":47,"whyStopped":11,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"ARM 1: High-Dose Cisplatin days 1, 22 & 43 with radiotherapy","ACTIVE_COMPARATOR",null,[13,14],"Drug: High-Dose Cisplatin","Radiation: Radiotherapy",{"label":16,"type":10,"description":11,"interventionNames":17},"ARM 2: Low-Dose Cisplatin Q 1 wk + radiotherapy",[18,14],"Drug: Low-Dose Cisplatin",[20,25,29],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","High-Dose Cisplatin","Intravenous administration of High-Dose Cisplatin",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Low-Dose Cisplatin","Intravenous administration of Low-Dose Cisplatin",[16],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":11},"RADIATION","Radiotherapy","Participating centres are to follow their local radiation treatment planning and delivery techniques.",[9,16],[35],{"name":36,"affiliation":37,"role":38},"Sara Kuruvilla, MD","London Health Sciences Centre, London Regional Cancer Program","PRINCIPAL_INVESTIGATOR",[40],{"name":36,"role":41,"phone":42,"phoneExt":11,"email":43},"CONTACT","(519)685-8500","sara@kuruvilla@lhsc.on.ca",[45,64,74],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Juravinski Cancer Centre","RECRUITING","Hamilton","Ontario","L8N 3Z5","Canada","CA",{"type":54,"coordinates":55},"Point",[56,57],-79.84963,43.25011,{"lat":57,"lon":56},[60],{"name":61,"role":41,"phone":62,"phoneExt":11,"email":63},"Brandon Meyers, MD","905-521-2100","meyersbr@hhsc.ca",{"facility":65,"status":66,"city":67,"state":49,"zip":68,"country":51,"countryCode":52,"cosmosGeoPoint":69,"geoPoint":73,"contacts":11},"London Regional Cancer Program","ACTIVE_NOT_RECRUITING","London","N6A 5W9",{"type":54,"coordinates":70},[71,72],-81.23304,42.98339,{"lat":72,"lon":71},{"facility":75,"status":47,"city":76,"state":49,"zip":77,"country":51,"countryCode":52,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Sunnybrook Health Sciences Centre","Toronto","M4N 3M5",{"type":54,"coordinates":79},[80,81],-79.39864,43.70643,{"lat":81,"lon":80},[84],{"name":85,"role":41,"phone":86,"phoneExt":11,"email":87},"Martin Smoragiewicz, MD","416-480-4617","martin.smoragiewicz@sunnybrook.ca",{"type":89,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100335563","low-dose-weekly-vs-high-dose-cisplatin-100335563",false,"NCT03649048","Low-Dose Weekly vs High-Dose Cisplatin","Randomized Trial Comparing Low-Dose Weekly to High-Dose Cisplatin Concurrent With Radiation for Locally Advanced Head and Neck Cancer.","RADIO","Inclusion Criteria:\n\n* Age 18 or older\n* Willing and able to provide written informed consent\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Histologically or cytologically confirmed squamous cell carcinoma\n* Primary tumor site includes oral cavity, oropharynx, nasal cavity, salivary glands (excluding parotid), hypopharynx, or larynx and primary unknown\n* Patients must be deemed suitable for HD cisplatin therapy based on tumor characteristics, clinical condition and comorbidities in the judgement of the treating medical oncologist.\n* Patients must be planned to receive radical intent radiation treatment based on clinical condition, comorbidities and tumor characteristics in the judgment of the treating radiation oncologist\n* Adequate organ and marrow function independent of transfusion for at least 7 days prior to randomization defined as:\n\n  * Hemoglobin \\> 80 g\u002FL; Absolute neutrophil count \\>1.5x10⁹ \u002FL, platelets \\>100x10⁹\u002FL; Bilirubin \\\u003C 35 umol\u002FL; AST or ALT \\\u003C 3 x the upper limit of normal; Calculated creatinine clearance (as determined by Cockcroft- Gault) \\> 50 ml\u002Fmin\n\nMales:\n\nCreatinine Clearance = Weight (kg) x (140 - Age) (mL\u002Fmin) 72 x serum creatinine (mg\u002FdL)\n\nFemales:\n\nCreatinine Clearance = Weight (kg) x (140 - Age) x 0.85 (mL\u002Fmin) 72 x serum creatinine (mg\u002FdL)\n\n* Patient must be assessed at head and neck cancer multidisciplinary clinic (with assessment by radiation oncologist and surgeon) and presented at multidisciplinary tumor board prior to randomization.\n\nExclusion Criteria:\n\n* Serious medical comorbidities or other contraindications to radiotherapy and\u002For chemotherapy.\n* Prior history of head and neck cancer within 5 years.\n* Nasopharyngeal primary confirmed or suspected.\n* Severe hearing loss as determined clinically Pre-existing use of hearing aids.\n* Peripheral neuropathy .grade 2 (CTCAE v4.02).\n* Prior or planned neoadjuvant chemotherapy prior to CRT.\n* Prior head and neck radiation at any time.\n* Distant metastatic disease.\n* Inability to attend full course of radiotherapy or follow-up visits.\n* Prior invasive malignant disease unless disease-free for at least 5 years or more, with the exception of non-melanoma skin cancer or in-situ carcinoma.\n* Unable or unwilling to complete QOL questionnaires.\n* Pregnant or lactating women.\n* Unable to use dual method of contraception.","ALL","18 Years",{"count":101,"type":102},100,"ESTIMATED","INTERVENTIONAL",[105],"NA","This study is a prospective open-label randomized clinical trial. Following informed consent eligible LASCCHN patients (n=100) planned for CRT will be stratified by tumor p16 status and then randomized in a 1:1 fashion to either concurrent HD cisplatin or concurrent weekly LD cisplatin.",[108],"Locally Advanced Head and Neck Squamous Cell Carcinoma","2025-07-28",{"date":111,"type":112},"2025-07-31","ACTUAL",{"date":114,"type":112},"2018-11-05",{"date":116,"type":102},"2028-09",{"name":5,"class":6},3]