Actively Recruiting
A Study on Using Cell-Free Tumor DNA (ctDNA) Testing to Decide When to StartRoutine Treatment in People With Human Papilloma Virus (HPV)- Associated Oropharynx Cancer (OPC)
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-13
30
Participants Needed
8
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will look at whether monitoring HPV ctDNA levels is an effective way to detect cancer relapse risk in people with HPV-OPC. All participants will have recently had surgery to treat their disease, or they will be scheduled to have this surgery. In Arm A the researchers will see whether monitoring participants' HPV ctDNA levels can safely identify patients who do not need radiation therapy (RT) after surgery and whose RT can be delayed until their HPV ctDNA levels become detectable. In Arm B, the researchers will see whether patients who usually need 6-6.5 weeks of CRT can be selected by HPV ctDNA to receive 3 weeks of CRT.
CONDITIONS
Official Title
A Study on Using Cell-Free Tumor DNA (ctDNA) Testing to Decide When to StartRoutine Treatment in People With Human Papilloma Virus (HPV)- Associated Oropharynx Cancer (OPC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG performance status of 0 to 2
- HPV-16 squamous cell carcinoma of the oropharynx or HPV-16 head and neck squamous cell carcinoma of unknown primary confirmed by in-situ hybridization
- Detectable HPV ctDNA by digital PCR with a minimum of 50 copies/mL before surgery
- Surgical removal of all visible disease with no gross disease on post-operative imaging
- Two undetectable HPV ctDNA tests (<1 copy/mL) within 2 to 6 weeks after surgery, at least one week apart
- For Arm A: at least one of the following pathologic criteria: AJCC 7 Stage pT0N1-N2b, pT1N1, pT2N1, or ≥pT3; or AJCC 7 ≥pN2; or lymphovascular invasion; or perineural invasion; or close pathologic margin (≤3 mm)
- For Arm B: at least one of the following pathologic criteria: microscopic positive margin or extracapsular extension
- Adequate blood counts and organ function within 30 days prior to registration (Arm B only)
- Negative serum pregnancy test within 14 days prior to registration for women of childbearing potential
- Signed informed consent form by participant or legally authorized representative
You will not qualify if you...
- Metastatic disease
- Non-HPV16 genotype (e.g., HPV-18, -31, -33, -35)
- Surgery performed at an outside institution (exceptions for high-volume centers at investigator discretion)
- Prior head and neck radiation therapy
- Pre-operative HPV ctDNA not available or ≤50 copies/mL
- Simultaneous primary cancers outside the oropharynx (exceptions possible at investigator discretion)
- Prior invasive malignancy unless disease-free for 3 years or with a 5-year cure rate ≥90% (exceptions possible)
- Prior systemic chemotherapy for the study cancer (prior chemo for other cancers allowed)
- Severe active co-morbid conditions such as unstable angina, recent myocardial infarction, active infection requiring IV antibiotics, recent respiratory hospitalization, or hepatic insufficiency
- Inability to understand or willingness to provide informed consent and complete questionnaires
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Trial Site Locations
Total: 8 locations
1
Baptist Alliance MCI (Data Collection Only)
Miami, Florida, United States, 33143
Actively Recruiting
2
Memorial Sloan Kettering Basking Ridge (Limited protocol activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
3
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
4
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
5
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
6
Memorial Sloan Kettering Westchester (Limited Protocol Activites)
East White Plains, New York, United States, 10604
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
8
Memorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, New York, United States, 11553
Actively Recruiting
Research Team
A
Acharf Shamseddine, MD
CONTACT
N
Nancy Lee, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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