[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558671":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":47,"collaborators":49,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":20,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":20,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Georgetown University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Radiation dose: 50Gy","EXPERIMENTAL","50Gy in 25 fractions to the neck at risk for tumor recurrence, excluding the primary site",[13],"Radiation: Radiation Therapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"RADIATION","Radiation Therapy","De-escalation of Adjuvant Radiotherapy",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Peter Ahn, MD","CONTACT","(202) 444-4036","Peter.H.Ahn@gunet.georgetown.edu",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Medstar Georgetown University Hospital","RECRUITING","Washington D.C.","District of Columbia","20007","United States","US",{"type":37,"coordinates":38},"Point",[39,40],-77.03637,38.89511,{"lat":40,"lon":39},[43,45],{"name":23,"role":24,"phone":44,"phoneExt":20,"email":26},"202-444-4036",{"name":23,"role":46,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"type":48,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[50],{"name":51,"class":6},"MedStar Georgetown University Hospital","100558671","de-escalation-of-adjuvant-radiation-for-low-risk-hpv-oropharyngeal-cancers-100558671",false,"NCT06554158","De-escalation of Adjuvant Radiation for Low-Risk HPV Oropharyngeal Cancers","A Phase II Study of Post-Resection Radiation Dose and Treatment Site De-Escalation for Favorable Prognosis Human Papilloma Virus (HPV) or p16-Positive Oropharyngeal Cancer","Inclusion Criteria:\n\n* Patients must be ≥ 18 years of age on the day of signing informed consent.\n* Patients must have a diagnosis of p16+ and\u002For HPV+ squamous cell carcinoma of the oropharynx (including base of tongue, glossotonsilar sulcus, tonsil, soft palate, vallecula, and\u002For posterior oropharyngeal wall).\n* pathologic stage T1-2 N1 M0 (AJCC 8th ed.) stage I or T3 N0-1 M0 stage II (AJCC 8th ed.) SCCA of the oropharynx, with ≤ 5 distinct nodes involved with tumor, ≤ 2mm ECE (extracapsular extension), ≥ 2mm surgical margins at primary site.\n* Karnofsky Performance Status (KPS) ≥ 60 within 8 weeks prior to registration.\n* neutrophil:lymphocyte ratio ≤ 5 within 8 weeks of registration.\n* hemoglobin count ≥ 10 within 8 weeks of registration. The patient may receive transfusion to reach this goal.\n* current non-smoker (at least 6 months) with ≤ 15 pack-year smoking history\n* start radiation within 8 weeks of resection (6 weeks preferable)\n* have undergone resection of the primary site with Transoral Surgery and neck dissection of at least the ipsilateral neck\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n* Ability to understand and willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Perineural invasion at primary site\n* Lymphovascular space invasion at primary site\n* Level 4 nodal involvement (even if resected)\n* Retropharyngeal nodal involvement (even if resected)\n* any intact, unresected disease\n* nodal disease pathologically invading adjacent neck musculature\n* Patients treated via an invasive, non-oral approach to the primary site, including jaw-splitting mandibulotomy with resection or lateral pharyngotomy\n* Prior history of malignancy diagnosed within 2 years prior to registration, except for nonmelanomatous skin cancer that has completed treatment and the patient is deemed as being disease-free or Gleason 6 prostate cancer that is undergoing active surveillance.\n* Patient with extracapsular extension (ECE) who has not had a biopsy of an ipsilateral neck lymph node that demonstrated squamous cell carcinoma",true,"ALL","18 Years",{"count":63,"type":64},30,"ESTIMATED","INTERVENTIONAL",[67],"NA","The goal of this clinical trial is to learn whether for intermediate-risk patients who have undergone Transoral Robotic Surgery for HPV\u002Fp16(+) oropharyngeal cancer and have minimal smoking history, whether these patients can be treated with a lower-than standard dose, with omission of the primary site in the oropharynx. The main questions it aims to answer are:\n\nDoes radiotherapy site and dose-de-escalation lead to similar outcomes compared to historical data on tumor control in patients who are treated with standard radiation doses and treatment fields?\n\nParticipants will:\n\nUndergo treatment with a lower than standard radiation dose (50Gy in 25 fractions, with either Intensity Modulated Radiation Therapy (IMRT) or proton beam therapy) and to a smaller than standard radiation field (to the neck only, excluding the original site of tumor in the oropharynx)",[70],"Oropharynx Cancer",[72,73,74,75,76],"HPV","tonsil","base of tongue","soft palate","oropharyngeal cancer","2026-03-19",{"date":79,"type":80},"2026-03-23","ACTUAL",{"date":82,"type":80},"2019-08-01",{"date":84,"type":64},"2028-12-31",{"name":5,"class":6},1]