[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560570":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":37,"centralContacts":44,"locations":53,"responsibleParty":98,"collaborators":101,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":111,"sex":117,"minAge":118,"maxAge":27,"enrollmentInfo":119,"targetDuration":27,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":129,"overallStatus":139,"whyStopped":27,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm1: Standard of Care Treatment","ACTIVE_COMPARATOR","Radiotherapy to Ipsilateral Neck and to risk Mucosa\n\nThere are two possible dose levels:\n\n* 60 Gy in 30 fractions over 6 weeks (CTV60)\n\n  o This applies to the dissected levels of the neck\n* 54 Gy in 30 fractions over 6 weeks (CTV54)\n\n  * This applies to the mucosal surfaces. Patients randomized to Arm 2 will not have the mucosal surfaces treated",[13,14,15],"Radiation: Intensity Modulated Radiotherapy (IMRT) to Mucosa at Risk","Procedure: Surgical Intervention","Radiation: Intensity Modulated Radiotherapy (IMRT) to Ipsilateral Neck",{"label":17,"type":18,"description":19,"interventionNames":20},"Arm 2: Omission of IMRT to Risk Mucosa but conditional IMRT to Neck","EXPERIMENTAL","* If N1 with single node \\\u003C= 3cm, no further treatment\n* If multiple ipsilateral nodes or single ipsilateral node \\>3 cm, radiation to Neck only",[14,15],[22,28,33],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"RADIATION","Intensity Modulated Radiotherapy (IMRT) to Mucosa at Risk","Patients in Arm 1, after the surgical procedure, will receive radiotherapy to the at-risk mucosa.",[9],null,{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":27},"PROCEDURE","Surgical Intervention","These patients will undergo Neck dissection, TORS tonsillectomy (unilateral vs bilateral tonsillectomy at the discretion of the treating physician) + ipsilateral tongue base mucosectomy.",[17,9],{"type":23,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"Intensity Modulated Radiotherapy (IMRT) to Ipsilateral Neck","For Arm1, after the surgical procedure, the patients will receive radiotherapy to the ipsilateral neck. For Arm2, the patients will only receive IMRT to neck, if multiple ipsilateral nodes or single ipsilateral node \\>3 cm is observed",[17,9],[38,41],{"name":39,"affiliation":5,"role":40},"Adrian I Mendez, MD","PRINCIPAL_INVESTIGATOR",{"name":42,"affiliation":43,"role":40},"Jake Jervis-Bardy, MD","Royal Adelaide Hospital",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":27,"email":49},"Halema Khan, PhD","CONTACT","5196858500","halema.khan@lhsc.on.ca",{"name":39,"role":47,"phone":51,"phoneExt":27,"email":52},"5196858058","adrian.mendez@lhsc.on.ca",[54,73,83],{"facility":43,"status":27,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Adelaide","South Australia","5000","Australia","AU",{"type":61,"coordinates":62},"Point",[63,64],138.59863,-34.92866,{"lat":64,"lon":63},[67,71],{"name":68,"role":47,"phone":69,"phoneExt":27,"email":70},"Jake Jerivs-Bardy","+1670740000","jake.jervis-bardy@sa.gov.au",{"name":72,"role":40,"phone":27,"phoneExt":27,"email":27},"Jake Jervis-Bardy",{"facility":74,"status":27,"city":55,"state":56,"zip":75,"country":58,"countryCode":59,"cosmosGeoPoint":76,"geoPoint":78,"contacts":79},"Flinders Medical Centre","5042",{"type":61,"coordinates":77},[63,64],{"lat":64,"lon":63},[80,82],{"name":72,"role":47,"phone":81,"phoneExt":27,"email":27},"+6182045511",{"name":72,"role":40,"phone":27,"phoneExt":27,"email":27},{"facility":84,"status":27,"city":85,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"London Health Sciences Centre","London","Ontario","N6A 5W9","Canada","CA",{"type":61,"coordinates":91},[92,93],-81.23304,42.98339,{"lat":93,"lon":92},[96],{"name":97,"role":47,"phone":51,"phoneExt":27,"email":52},"Adrian Mendez, MD",{"type":40,"investigatorFullName":99,"investigatorTitle":100,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Adrian Mendez","Study Principal Investigator",[102,105,107],{"name":103,"class":104},"Dr. Jake Jervis-Bardy","UNKNOWN",{"name":106,"class":104},"Dr. David Palma",{"name":108,"class":104},"Dr. Adam Mutsaers","100560570","phase-2-surgery-and-reducing-ionizing-radiation-of-the-unknown-primary-100560570",false,"NCT06578871","Surgery and Reducing Ionizing Radiation of the Unknown Primary","Surgery for the Unknown Primary in the Era of p16-positive Oropharyngeal Squamous Cell Carcinoma: Reducing Ionizing Radiation (SUPERIOR): A Randomized Trial","SUPERIOR","Inclusion criteria for the Registration phase\n\n* p16 positive PUK SCC of the neck\n* Age 18 years or older\n* Willing to provide informed consent\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Clinical nodal stage N1, AJCC 8th edition (i.e. clinical unilateral nodal disease, none larger than 6 cm)\n* Complete clinical work-up, including CT neck, physical examination with nasopharyngoscopy, and PET\u002FCT, with no evidence of a primary tumor. The PET\u002FCT scan must be without focal metabolic activity concerning for a primary tumor, in the opinion of the nuclear medicine physician. Metabolic activity, particularly in the tonsils and base of the tongue which is within normal physiologic range, does not exclude participation.\n\nInclusion criteria for the Randomization phase\n\n* Completed ipsilateral tonsillectomy and base of tongue mucosectomy with no evidence of a primary tumor\n\n  o Note, patients who had a PET\u002FCT that was initially positive, and therefore not meeting criteria in 4.10, but panendoscopy with biopsies of the fluorodeoxyglucose (FDG)-avid areas do not show malignancy, can then be enrolled and would be returned the OR for a neck dissection prior to randomization\n* Ipsilateral nodal disease on pathology with no evidence of extranodal extension\n\nExclusion Criteria:\n\n* Radiological or pathological extra-nodal extension\n* Epstein-Barr Virus (EBV)-positive\n* Clinical nodal stage (i.e. before neck dissection) N2-3, AJCC 8th edition (ie. bilateral nodes or node \\>6cm)\n* Pathological nodal stage (i.e. after neck dissection) pN3\n* Prior history of head and neck cancer within 2 years\n* Any other active invasive malignancy, except non-melanotic skin cancers, low-risk prostate cancer, and stage I-IVA papillary or follicular thyroid cancer\n* Known metastatic disease\n* Unable to complete QOL questionnaires\n* Pregnant or lactating women","ALL","18 Years",{"count":120,"type":121},90,"ESTIMATED","INTERVENTIONAL",[124],"PHASE2","About 3% of people with head and neck cancer have cancer in their lymph nodes, but doctors are unable to find the primary tumour. This situation has become more common due to human papillomavirus (HPV), a virus linked to certain cancers. Generally, patients with HPV-related cancers have a good outlook, with around 90% surviving for at least five years.\n\nRecent advancements in medical technology, such as advanced imaging and specialized surgeries, have significantly improved doctors' ability to find these hidden tumours. These techniques can locate the primary tumour in 70-80% of cases. If the tumour remains undetected, it could be very small or potentially eliminated by the body's immune system.\n\nThe best way to treat this type of cancer is still debated. Current treatment options include surgery to remove lymph nodes or radiation therapy. There is no clear agreement on which areas should receive radiation. Often, surgery is performed on one side of the throat to try and locate the tumour's origin.\n\nResearchers are exploring ways to minimize the harmful side effects of treatment. Some studies suggest that surgery alone might be sufficient for patients with small tumours in their neck, but more research is needed. Another important question is whether radiation needs to cover the entire throat area. Recent findings suggest that omitting radiation from some areas might reduce side effects such as difficulty swallowing and dry mouth.\n\nThe SUPERIOR trial aims to investigate whether reducing the amount of radiation can still be effective and improve patients' quality of life. The study also examines whether surgery alone is adequate for certain patients with HPV-related cancers.",[127,128],"Head and Neck Squamous Cell Carcinoma","HPV Positive Oropharyngeal Squamous Cell Carcinoma",[130,131,132,133,134,135,136,137,138],"HPV-Mediated PUK","Head and Neck Cancer","P16+","Radiation Therapy","Oropharyngeal Cancer","Squamous Cell Carcinoma","Transoral Robotic Surgery (TORS)","Mucosal Radiation","SUPERIOR Trial","NOT_YET_RECRUITING","2024-08-29",{"date":142,"type":143},"2024-09-03","ACTUAL",{"date":145,"type":121},"2025-01-01",{"date":147,"type":121},"2027-05-30",{"name":5,"class":6},3]