OncoMatch/Clinical Trials/NCT06323460
Adaptive De-intensified Radiotherapy Using Circulating Tumor DNA in HPV- Associated Oropharyngeal Cancer
Is NCT06323460 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Carboplatin and Cisplatin for clinical stage i hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8.
Treatment: Carboplatin · Cisplatin · Paclitaxel — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: CDKN2A p16 positive immunohistochemical staining (positive)
P16 positive immunohistochemical staining
Required: HPV TTMV-HPV particles in plasma cell free DNA >= 200 copies/mL at baseline (>= 200 copies/mL)
Pretreatment tumor tissue modified HPV virus (TTMV-HPV) particles present in plasma cell free DNA value of >= 200 copies/mL at baseline
Disease stage
Required: Stage T0, N1-N2, T1-2, N1-N2, T3-T4, N0-2 (AJCC 8th edition)
Clinical stage T0, N1-N2, T1-2, N1-N2, T3-T4, N0-2 (American Joint Committee on Cancer [AJCC] 8th edition) including no evidence of distant metastases
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic chemotherapy
Prior systemic chemotherapy or immunotherapy
Cannot have received: immunotherapy
Prior systemic chemotherapy or immunotherapy
Cannot have received: radiotherapy
Exception: would result in overlap of radiation fields
Prior radiotherapy that would result in overlap of radiation fields
Lab requirements
Blood counts
Absolute neutrophil count: >= 1500/mcL; Platelets: >= 100,000/mcL; Hemoglobin >= 8.0 g/dL (use of transfusion or other intervention to achieve this is acceptable) (within 14 days prior to registration)
Kidney function
Serum creatinine <= 1.5 x institutional upper limit of normal or creatinine clearance >= 50 mL/min (Cockcroft-Gault Formula) (within 14 days prior to registration)
Liver function
Total bilirubin >= 1.5 x institutional upper limit of normal; AST or ALT >= 3.0 x institutional upper limit of normal (within 14 days prior to registration)
Absolute neutrophil count: >= 1500/mcL (within 14 days prior to registration); Platelets: >= 100,000/mcL (within 14 days prior to registration); Hemoglobin >= 8.0 g/dL (use of transfusion or other intervention to achieve this is acceptable) (within 14 days prior to registration); Total bilirubin >= 1.5 x institutional upper limit of normal (within 14 days prior to registration); AST or ALT >= 3.0 x institutional upper limit of normal (within 14 days prior to registration); Serum creatinine <= 1.5 x institutional upper limit of normal or creatinine clearance >= 50 mL/min (Cockcroft-Gault Formula) (within 14 days prior to registration)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Ohio State University Comprehensive Cancer Center · Columbus, Ohio
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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