[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100370561":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":32,"responsibleParty":49,"collaborators":51,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":18,"enrollmentInfo":65,"targetDuration":18,"studyType":68,"phases":69,"briefSummary":60,"conditions":71,"keywords":18,"overallStatus":34,"whyStopped":18,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"AHS Cancer Control Alberta","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"De-intensified chemoradiotherapy","EXPERIMENTAL","Radiotherapy to a dose of 60 Gy to the primary tumour and involved lymph nodes and 54 Gy to subclinical regions at risk in 30 fractions. Reduced volume of elective nodal radiation.",[13],"Radiation: De-intensified chemoradiotherapy",[15],{"type":16,"name":9,"description":11,"armGroupLabels":17,"otherNames":18},"RADIATION",[9],null,[20],{"name":21,"affiliation":22,"role":23},"Harvey Quon, MD","Tom Baker Cancer Centre","PRINCIPAL_INVESTIGATOR",[25,29],{"name":21,"role":26,"phone":27,"phoneExt":18,"email":28},"CONTACT","403-521-3619","harvey.quon@ahs.ca",{"name":30,"role":26,"phone":18,"phoneExt":18,"email":31},"Kelsey Meyer","Kelsey.Meyer@ahs.ca",[33],{"facility":22,"status":34,"city":35,"state":36,"zip":18,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Calgary","Alberta","Canada","CA",{"type":40,"coordinates":41},"Point",[42,43],-114.08529,51.05011,{"lat":43,"lon":42},[46,48],{"name":21,"role":26,"phone":18,"phoneExt":18,"email":47},"Harvey.Quon@ahs.ca",{"name":30,"role":26,"phone":18,"phoneExt":18,"email":31},{"type":50,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[52,53],{"name":22,"class":6},{"name":54,"class":6},"Cross Cancer Institute","100370561","p16-oropharyngeal-cancer-radiation-optimization-trial-reducing-elective-treatment-volumes-protect-100370561",false,"NCT04104945","p16+ Oropharyngeal Cancer Radiation Optimization Trial Reducing Elective Treatment Volumes (PROTEcT)","Volume and Dose De-Intensified Radiotherapy for p16+ Squamous Cell Carcinoma of the Oropharynx: A Multi-Centre, Single Arm Prospective Cohort Study","PROTEcT","Inclusion Criteria:\n\n* Age 18 or older\n\n  * Provide informed consent\n  * ECOG performance status 0-2\n  * Histologically confirmed squamous cell carcinoma\n  * p16-positive tumor, as determined by immunohistochemistry at local hospital\n  * Primary tumor site in the oropharynx (includes tonsil, soft palate, base of tongue, walls of oropharynx)\n  * Eligible for curative intent treatment.\n  * Smokers and non-smokers are included\n  * Tumor stage (AJCC 8th edition): T1 to T3\n  * Nodal stage (AJCC 8th edition): N1 to N2\n  * Adequate bone marrow function, hepatic, and renal function for chemotherapy (Hemoglobin \\> 80 g\u002FL; Absolute neutrophil count \\>1.5x109 \u002FL, platelets \\> 100 x109\u002FL; Bilirubin \\\u003C 35 umol\u002FL; AST or ALT \\\u003C 3 x the upper limit of normal; serum creatinine \\\u003C 130 umol\u002FL or creatinine clearance ≥ 50 ml\u002Fmin)\n\nExclusion Criteria:\n\n* \\- Clinical, radiologic or pathologic Ib nodal involvement (including invasion into submandibular gland)\n* Primary cancer with extension and involvement of the oral cavity\n* Metastatic disease\n* Contraindications to radiotherapy or chemotherapy\n* Prior history of head and neck cancer within 5 years\n* Prior head and neck radiation at any time\n* Inability to attend full course of radiotherapy or follow-up visits\n* Pregnant or lactating women","ALL","18 Years",{"count":66,"type":67},32,"ESTIMATED","INTERVENTIONAL",[70],"NA",[72],"Squamous Cell Carcinoma of the Oropharynx","2024-03-01",{"date":75,"type":76},"2024-03-04","ACTUAL",{"date":78,"type":76},"2021-01-12",{"date":80,"type":67},"2028-10-21",{"name":5,"class":6},1]