Actively Recruiting
Adaptive Treatment De-escalation in Favorable Risk HPV-Positive Oropharyngeal Carcinoma
Led by NYU Langone Health · Updated on 2026-01-06
120
Participants Needed
1
Research Sites
580 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Adaptive Treatment De-escalation in Favorable Risk HPV-Positive Oropharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of squamous cell carcinoma of the oropharynx confirmed by pathology
- Tumor tissue positive for p16 by immunohistochemical staining (>70% staining)
- Detectable HPV circulating tumor DNA in plasma at screening or baseline
- Clinical stage T1-T3, N1-N2b without distant metastases
- Required imaging within 8 weeks prior to registration including CT or MRI and PET/CT
- Personal smoking history of 10 pack-years or less
- Zubrod Performance Status of 0 or 1 within 8 weeks prior to registration
- Adequate blood counts within 2 weeks prior to registration
- Adequate kidney function within 2 weeks prior to registration
- Negative pregnancy test within 14 days prior to registration for women of childbearing potential
- HIV positive patients allowed if no prior AIDS-defining illness and CD4 counts at least 350/mm3
- No hepatitis B or C infection unless immune to hepatitis B
- Provided informed consent
You will not qualify if you...
- Missing or undetectable baseline plasma HPV DNA
- Cancer originating from oral cavity, nasopharynx, hypopharynx, or larynx
- Neck cancer of unknown primary origin
- Distant metastasis or lymph node involvement below the clavicles
- Complete removal of both primary tumor and nodal disease prior to study
- Multiple or bilateral primary tumors
- Prior invasive cancer within 3 years except non-melanoma skin cancer
- Prior chemotherapy for this cancer
- Prior radiotherapy overlapping the study area
- Severe active illnesses such as recent unstable angina, heart failure, or serious infections
- Liver failure causing jaundice or clotting problems
- AIDS or advanced immune deficiency beyond criteria
- Pregnancy
- Allergic reaction to cisplatin
- MRI contraindications including pacemakers, metal implants, claustrophobia, seizures
- Severe kidney failure (GFR <15 ml/min/1.73m2) or dialysis preventing contrast MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
New York University School of Medicine
New York, New York, United States, 10016
Actively Recruiting
Research Team
K
Kenneth Hu
CONTACT
F
Fraustina Hsu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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