OncoMatch/Clinical Trials/NCT04444869
Testing Less Intensive Radiation With Chemotherapy to Treat Low-risk Patients With HPV-positive Oropharyngeal Cancer
Is NCT04444869 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Cisplatin for cancer of the head and neck.
Treatment: Cisplatin — This trial will explore giving standard dose chemotherapy and radiation therapy to sites of disease including all lymph nodes involved with HPV-positive oropharyngeal cancer, but administer lower doses of radiation therapy to the lymph nodes that are not known to be involved with cancer. By doing so, it is hypothesized that there will be equally good long term loco-regional and distant disease control but will reduced long term treatment side effects and improved quality of life in persons living well beyond their cancer treatment.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: CDKN2A p16 positive (positive)
Immunohistochemical staining for p16 must be performed on tissue and documented in the pathology report(s) with reported result positive for p16.
Disease stage
Required: Stage T1-T3, N0-N2C (AJCC, 7TH ED.), N0-2 (AJCC, 8TH ED.) (AJCC 7th and 8th edition)
Excluded: Stage T1-T2 N0-1 LATERALIZED SQUAMOUS CELL CARCINOMA OF THE TONSIL
Clinical stage T1-T3, N0-N2c (AJCC, 7th ed.), which is equal to T1-T3, N0-2 (AJCC, 8th ed.) including no distant metastases
Performance status
ZUBROD 0–1
Prior therapy
Cannot have received: systemic chemotherapy
Exception: prior chemotherapy for a different cancer is allowable
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Cannot have received: radiation therapy
Exception: if would result in overlap of radiation therapy fields
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dl (transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable)
Kidney function
Serum creatinine < 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min
Liver function
Bilirubin < 2 mg/dl; AST or ALT < 3 x the upper limit of normal
Adequate hematologic function within 14 days prior to registration, defined as follows: Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dl; Adequate renal function within 14 days prior to registration, defined as follows: Serum creatinine < 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min; Adequate hepatic function within 14 days prior to registration defined as follows: Bilirubin < 2 mg/dl; AST or ALT < 3 x the upper limit of normal.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Missouri · Columbia, Missouri
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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