OncoMatch/Clinical Trials/NCT03215719
Adaptive Treatment De-escalation in Favorable Risk HPV-Positive Oropharyngeal Carcinoma
Is NCT03215719 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Cisplatinum for oropharyngeal carcinoma.
Treatment: Cisplatinum — This is a phase II clinical trial. The purpose of this study is to determine the feasibility of deescalating chemoradiation treatment based on mid-treatment tumor response determined by rapid nodal shrinkage and clearance of circulating HPV plasma tumor DNA . The primary objective of this study is to evaluate progression-free survival at 2 years.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: CDKN2A p16 positive (>70% staining by immunohistochemistry)
Patient's tissue must be positive for p16 by immunohistochemical staining (>70% staining)
Required: HPV detectable ctDNA (detectable)
Patients must have detectable HPV ctDNA Score Report at Screening or have a detectable baseline HPV ctDNA Score Report (Naveris test) if no primary site is biopsied. Must have detectable screening plasma HPV DNA (also referred to as ctHPV DNA).
Disease stage
Required: Stage T1-T3, N1-N2B (AJCC 7th Edition)
Clinical stage T1-T3, N1-N2b (AJCC 7th Edition) with no distant metastases
Performance status
ZUBROD 0–1
Prior therapy
Cannot have received: systemic chemotherapy
Exception: for the study cancer
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Cannot have received: radiotherapy
Exception: to the region of the study cancer that 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
ANC ≥ 1,500 cells/mm3; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥ 8.0 g/dl (transfusion/intervention allowed to achieve Hgb ≥ 8.0)
Kidney function
Serum creatinine ≤ 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min determined by 24 hour collection or estimated by Cockcroft-Gault formula
Adequate hematologic function within 2 weeks 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 2 weeks prior to registration, defined as follows: Serum creatinine ≤ 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min determined by 24 hour collection or estimated by Cockcroft-Gault formula; Severe, active co-morbidity defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months; Transmural myocardial infarction within the last 6 months; Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol other than those listed in 4.1.10.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- New York University School of Medicine · New York, New York
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