{"preliminary_commentary":{"by_channel":{"x_thread":12,"podcast":4,"youtube":3,"bluesky_thread":2},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03952585\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"name":"NRG-HN005","nct_id":"NCT03952585","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nrg-hn005-nct03952585. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1250,"size":"standard","size_rule":"Standard: 151–300 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Patients undergo standard dose RT as 70 Gy IMRT or IGRT over 6 fractions per week and receive 100 mg/m\\^2/day cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.","label":"Arm I (Standard RT + cisplatin)","type":"ACTIVE_COMPARATOR"},{"description":"Patients undergo reduced dose RT as 60 Gy IMRT or IGRT QD over 5 fractions per week and receive 100 mg/m\\^2/day cisplatin IV over 30-60 minutes on days 1 and 22. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.","label":"Arm II (Reduced RT + cisplatin)","type":"EXPERIMENTAL"},{"description":"Beginning 1 week prior to radiation, patients receive 240 mg fixed dose nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks (14 days) for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo reduced dose RT as 60 Gy IMRT or IGRT over 6 fractions per week for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients receive FDG and undergo PET/CT or CT during screening and during follow up, and undergo MRI during follow up. Patients may also undergo tissue biopsy and blood sample collection throughout the study.","label":"Arm III (Reduced RT + nivolumab)","type":"EXPERIMENTAL"}],"collaborators":["NRG Oncology"],"completion_date":{"date":"2026-12-11","type":"ESTIMATED"},"conditions":["Basaloid Squamous Cell Carcinoma","Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Oropharyngeal Squamous Cell Carcinoma","Papillary Squamous Cell Carcinoma","Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Squamous Cell Carcinoma"],"enrollment":{"count":384,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Biopsy Procedure","otherNames":["Biopsy","BIOPSY_TYPE","Bx"],"type":"PROCEDURE"},{"name":"Biospecimen Collection","otherNames":["Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection"],"type":"PROCEDURE"},{"name":"Cisplatin","otherNames":["Abiplatin","Blastolem","Briplatin","CDDP","Cis-diammine-dichloroplatinum","Cis-diamminedichloridoplatinum","Cis-diamminedichloro Platinum (II)","Cis-diamminedichloroplatinum","Cis-dichloroammine Platinum (II)","Cis-platinous Diamine Dichloride","Cis-platinum","Cis-platinum II","Cis-platinum II Diamine Dichloride","Cismaplat","Cisplatina","Cisplatinum","Cisplatyl","Citoplatino","Citosin","Cysplatyna","DDP","Lederplatin","Metaplatin","Neoplatin","Peyrone's Chloride","Peyrone's Salt","Placis","Plastistil","Platamine","Platiblastin","Platiblastin-S","Platinex","Platinol","Platinol- AQ","Platinol-AQ","Platinol-AQ VHA Plus","Platinoxan","Platinum","Platinum Diamminodichloride","Platiran","Platistin","Platosin"],"type":"DRUG"},{"name":"Computed Tomography","otherNames":["CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","Diagnostic CAT Scan","Diagnostic CAT Scan Service Type","tomography"],"type":"PROCEDURE"},{"name":"Fludeoxyglucose F-18","otherNames":["18FDG","FDG","Fludeoxyglucose (18F)","fludeoxyglucose F 18","Fludeoxyglucose F18","Fluorine-18 2-Fluoro-2-deoxy-D-Glucose","Fluorodeoxyglucose F18"],"type":"OTHER"},{"name":"Image Guided Radiation Therapy","otherNames":["IGRT","Image Guided Radiotherapy","image-guided radiation therapy","Image-Guided Radiotherapy"],"type":"RADIATION"},{"name":"Intensity-Modulated Radiation Therapy","otherNames":["IMRT","Intensity modulated radiation therapy (procedure)","Intensity Modulated RT","Intensity-Modulated Radiotherapy","Radiation, Intensity-Modulated Radiotherapy"],"type":"RADIATION"},{"name":"Magnetic Resonance Imaging","otherNames":["Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI"],"type":"PROCEDURE"},{"name":"Nivolumab","otherNames":["ABP 206","BCD-263","BMS 936558","BMS-936558","BMS936558","CMAB819","MDX 1106","MDX-1106","MDX1106","NIVO","Nivolumab Biosimilar ABP 206","Nivolumab Biosimilar BCD-263","Nivolumab Biosimilar CMAB819","ONO 4538","ONO-4538","ONO4538","Opdivo"],"type":"BIOLOGICAL"},{"name":"Positron Emission Tomography","otherNames":["Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","PT"],"type":"PROCEDURE"},{"name":"Quality-of-Life Assessment","otherNames":["Quality of Life Assessment"],"type":"OTHER"},{"name":"Questionnaire Administration","otherNames":[],"type":"OTHER"}],"last_update":"2026-07-02","lead_sponsor":"National Cancer Institute (NCI)","official_title":"A Randomized Phase II/III Trial of De-Intensified Radiation Therapy for Patients With Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2","PHASE3"],"primary_completion_date":{"date":"2024-03-01","type":"ACTUAL"},"primary_outcomes":[{"measure":"Progression-free Survival (PFS) (Phase II) (Percentage of Participants Alive Without Progression)","timeFrame":"From randomization to first progression or last follow-up. Maximum follow-up at the time of analysis was 4.6 years. The 1- and 2-year estimates are reported."},{"measure":"Progression-free Survival (Phase III) (Percentage of Participants Alive Without Progression)","timeFrame":"From randomization to first progression or last follow-up. Maximum follow-up was 4.6 years."},{"measure":"MD Anderson Dysphagia Inventory (MDADI) Global Quality of Life (QOL) Score","timeFrame":"Baseline to two years"}],"references":[],"start_date":{"date":"2019-10-09","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer","url":"https://clinicaltrials.gov/study/NCT03952585"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nrg-hn005-nct03952585"}