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 (Jun 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
Treatments studied
Other
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 →Frequently asked questions
Is NCT06984861 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior head and neck radiation therapy, systemic chemotherapy for the study cancer disqualifies patients from enrollment.
Does this trial require CDKN2A?
Yes, CDKN2A p16 overexpression (≥70% nuclear and cytoplasm expression; Ventana Medical Systems) is a required biomarker for enrollment.
Does this trial require HPV?
Yes, HPV mRNA in situ hybridization positive is a required biomarker for enrollment.
What disease stage is eligible?
Stage T3-4/N0-2C or ANY N3 REGARDLESS OF TSTAGE is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages