[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100376181":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":45,"locations":51,"responsibleParty":91,"collaborators":93,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":100,"sex":106,"minAge":107,"maxAge":25,"enrollmentInfo":108,"targetDuration":25,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":119,"overallStatus":54,"whyStopped":25,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Centre hospitalier de l'Université de Montréal (CHUM)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SABR boost and de-escalated chemoradiation","EXPERIMENTAL","SABR boost of 14 Gy in 2 fractions to the GTV, immediately followed by de-escalated chemoradiation. De-escalated chemoradiation will consist in 40 Gy in 20 fractions with concurrent high dose Cisplatin (3-weekly, 100 mg\u002Fm2) for 2 cycles, aiming for a cumulative dose of 200 mg\u002Fm2.",[13],"Radiation: SABR boost and de-escalated chemoradiation",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard chemoradiation","ACTIVE_COMPARATOR","The standard arm will consist of conventionally radiation to a dose of 70 Gy in 33 fractions concurrently with high dose Cisplatin (3-weekly, 100 mg\u002Fm2) for 2-3 cycles, aiming for a cumulative dose of ≥ 200 mg\u002Fm2.",[19],"Radiation: Standard chemoradiation",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"RADIATION","Stereotactic body radiotherapy boost to the gross tumor volume to a dose of 14 Gy in 2 fractions, followed by cisplatin-based chemoradiation to a dose of 40 Gy in 20 fractions",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Standard Cisplatin-based chemoradiation to a dose of 70 Gy in 33 fractions",[15],[30,33,35,39,42],{"name":31,"affiliation":5,"role":32},"Houda Bahig, MD PhD","STUDY_CHAIR",{"name":34,"affiliation":5,"role":32},"Phuc-Felix Nguyen-Tan, MD",{"name":36,"affiliation":37,"role":38},"David Palma, MD PhD","London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":41,"role":38},"Jack Phan, MD PhD","M.D. Anderson Cancer Center",{"name":43,"affiliation":44,"role":38},"Khalil Sultanem, MD","Montreal Jewish General Hospital",[46],{"name":47,"role":48,"phone":49,"phoneExt":25,"email":50},"Diane Trudel","CONTACT","514-890-8254","diane.dt.chum@ssss.gouv.qc.ca",[52,70],{"facility":53,"status":54,"city":55,"state":56,"zip":25,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"London Health Sciences Center","RECRUITING","London","Ontario","Canada","CA",{"type":60,"coordinates":61},"Point",[62,63],-81.23304,42.98339,{"lat":63,"lon":62},[66],{"name":67,"role":48,"phone":68,"phoneExt":25,"email":69},"Karen Eddy","(519) 685-8500","Karen.Eddy@lhsc.on.ca",{"facility":71,"status":54,"city":72,"state":73,"zip":74,"country":57,"countryCode":58,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Centre Hospitalier de l'Université de Montréal","Montreal","Quebec","H2X 1R6",{"type":60,"coordinates":76},[77,78],-73.58781,45.50884,{"lat":78,"lon":77},[81,86,88],{"name":82,"role":48,"phone":83,"phoneExt":84,"email":85},"Mom Phat","514-890-8000","26906","mom.phat.chum@ssss.gouv.qc.ca",{"name":87,"role":38,"phone":25,"phoneExt":25,"email":25},"Houda Bahig",{"name":89,"role":90,"phone":25,"phoneExt":25,"email":25},"Phuc-Félix Nguyen-Tan","SUB_INVESTIGATOR",{"type":38,"investigatorFullName":87,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Radiation Oncologist",[94,95,96],{"name":41,"class":6},{"name":37,"class":6},{"name":97,"class":6},"Jewish General Hospital","100376181","phase-3-stereotactic-boost-and-short-course-radiation-therapy-for-oropharynx-cancer-100376181",false,"NCT04178174","Stereotactic Boost and Short-course Radiation Therapy for Oropharynx Cancer","Stereotactic Boost and SHOrt-course Radiation Therapy for HPV-associated OroPharynx Cancer Trial: A Randomized Multicentric Phase III Trial","SHORT-OPC","Inclusion Criteria:\n\n* Age ≥18 years\n* Ability to provide written informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Biopsy proven diagnosis of squamous cell carcinoma of the oropharynx.\n* Positive for HPV by p16 immunohistochemistry (IHC) or HPV in-situ hybridization (ISH)\n* Clinical stage T1-3, N1 M0 (Stage I-II) as per AJCC 8th edition.\n* Primary tumor \\\u003C 30 cc\n* Planned for curative chemoradiation\n* For females of child-bearing age, a negative pregnancy test\n\nExclusion Criteria:\n\n* Clinical N3 classification, as per AJCC 8th edition\n* Clinically overt extranodal extension (ENE). As per AJCC 8th edition, clinically overt ENE is defined as invasion of the skin, infiltration of musculature\u002Ffixation to adjacent structures on clinical examination, cranial nerve, brachial plexus, sympathetic trunk or phrenic nerve invasion with dysfunction).\n* Previous irradiation of the head and neck region\n* Previous surgery of the HNC region (except for incisional or excisional biopsies)\n* Pregnancy or breastfeeding\n* Connective tissue disease\n* Any medical condition that could, in the opinion of the investigator, prevent follow-up after radiotherapy.\n* Non-Cisplatin concurrent chemotherapy\n* Prior induction chemotherapy","ALL","18 Years",{"count":109,"type":110},360,"ESTIMATED","INTERVENTIONAL",[113],"PHASE3","This is a randomized clinical trial comparing the outcomes of short-course chemoradiation consisting in stereotactic boost to the gross tumor and de-esclalated chemoradiation to the elective neck in human papilloma associated oropharynx cancer vs. the current standard 7-week course chemoradiation.",[116,117,118],"Head and Neck Cancer","Oropharynx Cancer","Human Papilloma Virus",[120,121,122,123,124,125,126],"head and neck cander","Oropharynx cancer","Human papilloma virus","Radiotherapy","Stereotactic body radiotherapy","Chemotherapy","De-intensification","2025-05-14",{"date":129,"type":130},"2025-05-18","ACTUAL",{"date":132,"type":130},"2020-02-23",{"date":134,"type":110},"2029-12",{"name":5,"class":6},2]