{"commentary":{"count":16,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":10,"podcast":4,"youtube":2},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"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 public preview; the full report is still bought."},"name":"NCT03952585","nct_id":"NCT03952585","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03952585. The price is fixed at order. We build the report after 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: 13–40 commentary sources"},"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","type":"PROCEDURE"},{"name":"Biospecimen Collection","type":"PROCEDURE"},{"name":"Cisplatin","type":"DRUG"},{"name":"Computed Tomography","type":"PROCEDURE"},{"name":"Fludeoxyglucose F-18","type":"OTHER"},{"name":"Image Guided Radiation Therapy","type":"RADIATION"},{"name":"Intensity-Modulated Radiation Therapy","type":"RADIATION"},{"name":"Magnetic Resonance Imaging","type":"PROCEDURE"},{"name":"Nivolumab","type":"BIOLOGICAL"},{"name":"Positron Emission Tomography","type":"PROCEDURE"},{"name":"Quality-of-Life Assessment","type":"OTHER"},{"name":"Questionnaire Administration","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":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct03952585"}