[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100431678":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":75,"collaborators":77,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":26,"enrollmentInfo":90,"targetDuration":26,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":103,"overallStatus":52,"whyStopped":26,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Centre hospitalier de l'Université de Montréal (CHUM)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard radiotherapy","ACTIVE_COMPARATOR","Radiotherapy as planned at baseline, with replanning allowed only if significant weight loss or change in anatomy due to unforeseen circumstances (eg that would affect dosimetry and treatment delivery of baseline treatment plan). No adaptation to shrinking tumour is allowed.",[13],"Radiation: Standard radiotherapy +\u002F- chemotherapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Adaptive radiotherapy","EXPERIMENTAL","Systematic radiation treatment plan adaptation according to the shrinking tumour on mid-treatment MRI.",[19],"Radiation: Experimental radiotherapy +\u002F- chemotherapy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"RADIATION","Standard radiotherapy +\u002F- chemotherapy","No radiotherapy adaptation unless major dosimetric deviation",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Experimental radiotherapy +\u002F- chemotherapy","Systemic MRI-based radiotherapy adaptation mid-treatment",[15],[32,50],{"facility":33,"status":34,"city":35,"state":26,"zip":26,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Austin Health","NOT_YET_RECRUITING","Melbourne","Australia","AU",{"type":39,"coordinates":40},"Point",[41,42],144.96332,-37.814,{"lat":42,"lon":41},[45,48],{"name":46,"role":47,"phone":26,"phoneExt":26,"email":26},"Sweet Ping Ng, MD PhD","CONTACT",{"name":46,"role":49,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Centre Hospitalier de l'Université de Montréal","RECRUITING","Montreal","Quebec","H2x 3E4","Canada","CA",{"type":39,"coordinates":59},[60,61],-73.58781,45.50884,{"lat":61,"lon":60},[64,68,70,72],{"name":65,"role":47,"phone":66,"phoneExt":26,"email":67},"Mom Phat","514-890-8254","mom.phat.chum@ssss.gouv.qc.ca",{"name":69,"role":47,"phone":66,"phoneExt":26,"email":67},"Silvine Benth",{"name":71,"role":49,"phone":26,"phoneExt":26,"email":26},"Edith Filion, MD",{"name":73,"role":74,"phone":26,"phoneExt":26,"email":26},"Houda Bahig, MD PhD","SUB_INVESTIGATOR",{"type":76,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[78],{"name":33,"class":79},"OTHER_GOV","100431678","phase-2-adaptive-radiotherapy-for-oropharynx-cancer-100431678",false,"NCT04901234","Adaptive RadioTherapy for OroPharynx Cancer","Adaptive RadioTherapy for Locally Advanced OroPharynx Cancer (ART-OPC) A Phase II Randomized Trial","ART-OPC","Inclusion Criteria:\n\n* Age ≥18 years\n* Ability to provide written informed consent.\n* Stage T3-T4N0-3 as per AJCC 8th edition\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Biopsy proven diagnosis of squamous cell carcinoma of the oropharynx.\n* Planned for curative radiotherapy +\u002F- chemotherapy\n* For females of child-bearing age, a negative pregnancy test\n* Patients treated with induction chemotherapy can be included if they have residual tumor in place.\n\nExclusion Criteria:\n\n* Previous irradiation of the head and neck (HNC) region, excluding superficial radiation therapy for non-melanomatous skin cancer\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* Patients with contra-indications to MRI will be excluded.","ALL","18 Years",{"count":91,"type":92},120,"ESTIMATED","INTERVENTIONAL",[95],"PHASE2","This is a phase II randomized trial, where patients with histologically proven squamous cell carcinoma of oropharynx that have primary tumor (T3 - T4) in place, treated with curative intent chemoradiation, will be randomized to systematic mid-treatment MRI-based radiotherapy adaptation vs. standard of care. The primary objective is to compare patient-rated dysphagia (as assessed by the MD Anderson Dysphagia Inventory composite score at 6 months post-treatment in patients undergoing routine mid-treatment MR-guided radiotherapy adaptation vs. in patients receiving the current standard of care.",[98,99,100,101,102],"Oropharynx Cancer","Radiotherapy; Complications","Radiotherapy Side Effect","Dysphagia","MRI",[104,105,106,107],"Oropharynx cancer","Radiotherapy","Adaptation","Magnetic resonance imaging","2023-12-11",{"date":110,"type":111},"2023-12-12","ACTUAL",{"date":113,"type":111},"2021-07-30",{"date":115,"type":92},"2026-12",{"name":5,"class":6},2]