OncoMatch/Clinical Trials/NCT06984861
A Study of Reduced Radiation Therapy With Chemotherapy in People With HPV-Positive Throat Cancer
Is NCT06984861 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Chemoradiation for oropharyngeal carcinoma.
Treatment: Chemoradiation — The researchers are doing this study is to find out if lower doses (given in fewer treatments over a shorter period of time) of radiation therapy in combination with standard-of-care chemotherapy is an effective treatment for people with Human Papilloma Virus (HPV)-positive throat cancer and works as well as the standard doses of radiation therapy in combination with standard-of-care chemotherapy. The chemotherapy drugs used in combination with radiation therapy in this study include cisplatin, carboplatin, and 5-fluorouracil (5-FU).
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: CDKN2A p16 overexpression (≥70% nuclear and cytoplasm expression; Ventana Medical Systems) (≥70% nuclear and cytoplasm expression)
A patient is HPV positive when he or she tests positive for both p16 expression (70% nuclear and cytoplasm expression; Ventana Medical Systems) and mRNA HPV in situ hybridization.
Required: HPV mRNA in situ hybridization positive
A patient is HPV positive when he or she tests positive for both p16 expression (70% nuclear and cytoplasm expression; Ventana Medical Systems) and mRNA HPV in situ hybridization.
Disease stage
Required: Stage T3-4/N0-2C, ANY N3 REGARDLESS OF TSTAGE (AJCC 7th Edition)
T3-4/N0-2c or any N3 regardless of Tstage (AJCC 7th Edition) HPV+ OPC* or HPV associated squamous cell carcinoma with nodal metastasis (es) but unknown primary sites without evidence of distant metastasis based on FDG PET/CT.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: head and neck radiation therapy
Subjects with prior head and neck radiation therapy
Cannot have received: systemic chemotherapy for the study cancer
Exception: one cycle of induction chemotherapy is allowed prior to registration based on clinical needs
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
Lab requirements
Blood counts
WBC ≥ 2 K/mcL; ANC ≥ 1,000 cells/mm^3; Platelets ≥ 100,000 cells/mm^3; 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
Liver function
Bilirubin ≤ 2 mg/dl; AST or ALT ≤ 3 x the upper limit of normal
Adequate hematologic function within 30 days prior to registration, defined as follows: WBC ≥ 2 K/mcL; ANC ≥ 1,000 cells/mm^3; Platelets ≥ 100,000 cells/mm^3; Hemoglobin ≥ 8.0 g/dl. Adequate renal function within 30 days 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. Adequate hepatic function within 30 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
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, New Jersey
- Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities) · Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) · Harrison, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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