[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04667585":3,"trial-entities:NCT04667585":117,"trial-summary:NCT04667585":122},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":47,"secondary_outcomes":52,"sex":71,"minimum_age":72,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":73,"std_ages":89,"locations":92,"central_contacts":109,"overall_officials":110,"references":115,"see_also_links":116},"NCT04667585","Pro00105899","Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx","Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx Using Metabolic Signature From Interim 18FDG-PET\u002FCT","ACTIVE_NOT_RECRUITING","2028-07","2026-06","2026-06-12","2021-04-12","Duke University","OTHER",false,"The purpose of this study is to use intra-treatment 18FDG-PET\u002FCT during definitive radiation therapy for human papillomavirus (HPV)-related oropharyngeal cancer (OPC) as an imaging biomarker to identify and select patients with a favorable response for chemoradiation dose de-escalation. This study will prospectively evaluate the clinical outcomes for patients undergoing dose de-escalation.",null,[19],"Oropharynx Cancer",[21],"PET-CT","INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},120,"ESTIMATED",[30,36,41],{"type":31,"name":32,"description":33,"armGroupLabels":34},"RADIATION","De-escalated radiation dose","Reduced dose of radiation applied to remaining radiation therapy when favorable interim PET-CT signature is produced",[35],"Interim PET-CT with dose de-escalation",{"type":31,"name":37,"description":38,"armGroupLabels":39},"Standard radiation dose","Standard dose of radiation applied to remaining radiation therapy when favorable PET-CT signature is not produced",[40],"Interim PET-CT with standard radiation",{"type":14,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT)","The CT scan - also called computerized tomography or just CT - combines a series of X-ray views taken from many different angles to produce cross-sectional images of the bones and soft tissues inside the body. CT scans in planning radiation therapy are standard of care. A PET is a highly specialized imaging technique that uses short-lived radioactive substances (such as FDG a simple sugar labeled with a radioactive atom) to produce three-dimensional colored images of those substances functioning within the body. These images are called PET scans and the technique is termed PET scanning. PET scanning provides information about the body's chemistry not available through other procedures. Unlike CT or MRI (magnetic resonance imaging), techniques that look at anatomy or body form, PET studies metabolic activity or body function.",[35,40],[46],"18 FDG-PET\u002FCT",[48],{"measure":49,"description":50,"timeFrame":51},"Progression-free survival","defined as the time between initiation of radiation treatment and the first documented recurrence of disease or death due to any cause as measured by medical record abstraction","from initiation of radiation therapy through study completion, an average of 2 years",[53,56,58,60,64,68],{"measure":54,"description":55,"timeFrame":51},"locoregional progression-free survival","as measured by abstraction from the medical record",{"measure":57,"description":55,"timeFrame":51},"distant disease-free survival",{"measure":59,"description":55,"timeFrame":51},"overall survival",{"measure":61,"description":62,"timeFrame":63},"progression free survival correlation in PET\u002FCT responders versus PET\u002FCT non-responders","as measured by the difference in median Kaplan-Meyer values","2 years",{"measure":65,"description":66,"timeFrame":67},"Acute adverse events","as measured by the number of participants who experience dermatitis, mucositis, xerostomia, dysphagia, dysgeusia, neutropenia, thrombocytopenia, nausea, vomiting, renal toxicity, and hearing loss","7 weeks",{"measure":69,"description":70,"timeFrame":63},"Long term adverse events","as measured by the number of participants who experience xerostomia, dysphagia, dysgeusia, trismus, lymphedema, superficial soft tissue fibrosis, hypothyroidism and periodontal disease","ALL","18 Years",{"inclusion":74,"exclusion":81,"raw_text":88},[75,76,77,78,79,80],"Histologic documentation of squamous cell carcinoma of the oropharynx with p16-positive immunohistochemical staining and\u002For positive HPV in situ hybridization (ISH) and\u002For positive HPV PCR","Stage I-III (AJCC 8th edition) with plan for concurrent chemotherapy per standard of care treatment","Zubrod\u002FECOG score of 0-1","Weight loss \\\u003C10% in the 3 months prior to diagnosis","≥ 18 years of age","No prior chemotherapy for their current cancer diagnosis",[82,83,84,85,86,87],"Prior radiotherapy to the head and neck","Medical contraindications to radiation therapy","Absence of gross disease on imaging prior to beginning radiation therapy","Distant metastatic disease","Medical contraindication to PET\u002FCT","History of active cancer other than non-melanoma skin cancer within the last 5 years","Inclusion Criteria:\n\n* Histologic documentation of squamous cell carcinoma of the oropharynx with p16-positive immunohistochemical staining and\u002For positive HPV in situ hybridization (ISH) and\u002For positive HPV PCR\n* Stage I-III (AJCC 8th edition) with plan for concurrent chemotherapy per standard of care treatment\n* Zubrod\u002FECOG score of 0-1\n* Weight loss \\\u003C10% in the 3 months prior to diagnosis\n* ≥ 18 years of age\n* No prior chemotherapy for their current cancer diagnosis\n\nExclusion Criteria:\n\n* Prior radiotherapy to the head and neck\n* Medical contraindications to radiation therapy\n* Absence of gross disease on imaging prior to beginning radiation therapy\n* Distant metastatic disease\n* Medical contraindication to PET\u002FCT\n* History of active cancer other than non-melanoma skin cancer within the last 5 years",[90,91],"ADULT","OLDER_ADULT",[93,102],{"facility":94,"city":95,"state":96,"zip":97,"country":98,"geoPoint":99},"Duke University Medical Center","Durham","North Carolina","27710","United States",{"lat":100,"lon":101},35.99403,-78.89862,{"facility":103,"city":104,"state":96,"zip":105,"country":98,"geoPoint":106},"Duke Raleigh Hospital","Raleigh","27609",{"lat":107,"lon":108},35.7721,-78.63861,[],[111],{"name":112,"affiliation":113,"role":114},"Jared Robbins, MD","DUHS","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":118,"biomarkers":120},[119],"Oropharyngeal Carcinoma",[121],"HPV",{"nct_id":4,"found":123,"summary":124,"prompt_version":134},true,{"design":125,"status":126,"heading":127,"summary":128,"follow_up":129,"word_count":130,"commitments":131,"compensation":132,"drugs_mentioned":133},"This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 120 participants, but the phase of the study is not specified.","completed","Radiotherapy Dose De-escalation for HPV-Associated Oropharynx Cancer","This study is for people with HPV-related oropharynx cancer (cancer of the middle part of the throat, linked to human papillomavirus). It aims to see if a reduced dose of radiation, called de-escalated radiation dose, can be used for some patients. You might receive this reduced dose if a special type of CT scan, called an 18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT) scan, shows a good response to initial treatment. Otherwise, you would receive the standard radiation dose. The study will look at how long people live without their cancer progressing (progression-free survival) over about 2 years. To join, you must have HPV-positive oropharynx cancer, be between 18 and an unspecified upper age, and meet other health criteria. The study is currently unclear about its recruitment status and plans to enroll 120 participants.","Participants will be followed from the start of radiation therapy through the study's completion, which is an average of 2 years, to measure progression-free survival.",135,"Not specified in the trial record.","Not stated in the trial record.",[32,37,42],"v2"]