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Adaptive De-intensified Radiotherapy Using Circulating Tumor DNA in HPV- Associated Oropharyngeal Cancer

StatusRecruiting
PhasePhase 2
Started2024-03-21
View on ClinicalTrials.gov ↗

Amendment history

2026-03-20
minor
Study Status, Sponsor/Collaborators, Oversight v2
Primary completion date2025-12-31→2026-12-31
Completion date2025-12-31→2026-12-31
2025-02-12
minor
Study Status, Oversight, Outcome Measures v1
Start dateestimated 2024-04-01→confirmed 2024-03-21
Secondary endpointsdetails revised at 1 of 3 entries
2024-03-14
minor
Original filing
This phase II trial studies how well using circulating tumor deoxyribonucleic acid (DNA) to guide lower dose radiation therapy works in treating patients with human papillomavirus infection (HPV)-associated oropharyngeal cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Recently, a blood test has been developed to detect the human papillomavirus in the blood and determine how many viral particles are present. Researchers want to compare any good and bad effects of using the lower dose radiation therapy with chemotherapy compared to the usual standard of care dose chemotherapy in patients who clear the human papillomavirus particles from their blood.
Trial Details
NCT Number NCT06323460
Lead Sponsor Ohio State University Comprehensive Cancer Center
Conditions 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
Enrollment 45 participants
Start Date 2024-03-21
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-24