Actively Recruiting
Phase II Trial Evaluating Minimal Residual Disease Directed Adjuvant Radiation in HPV-Associated Oropharynx Carcinoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-13
30
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether monitoring HPV circulating tumor DNA (ctDNA) levels can effectively detect the risk of cancer returning in people with HPV-associated oropharynx cancer (HPV-OPC) who have recently undergone or are scheduled for surgery. The study aims to determine if this monitoring can guide decisions about radiation therapy and chemotherapy, potentially allowing for delayed or reduced treatment. This is a Phase II trial sponsored by Memorial Sloan Kettering Cancer Center. Participants are divided into two groups. In Arm A, those with rising HPV ctDNA levels after surgery may have radiation therapy delayed until ctDNA becomes detectable, with radiation doses of 50-60 Gy planned. In Arm B, patients typically needing 6 to 6.5 weeks of chemoradiation may receive a shorter, 3-week course of radiation with concurrent chemotherapy. Both arms involve detailed imaging with FDG PET/CT scans for treatment planning and to check for cancer spread. Throughout the study, participants will undergo blood tests to measure HPV ctDNA, imaging scans, and complete questionnaires assessing quality of life and financial impact. Researchers will track progression-free survival over two years, along with detailed monitoring of treatment effects. Treatment is personalized based on ctDNA results and pathology findings, with ongoing assessments for safety and effectiveness during follow-up visits.
CONDITIONS
Brief 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 0-2
- Confirmed HPV-16 squamous cell carcinoma of the oropharynx or HPV-16 head and neck squamous cell carcinoma of unknown primary
- Detectable HPV ctDNA with at least 50 copies/mL before surgery
- Surgical removal of all visible disease with no gross disease on post-operative imaging
- Two undetectable post-operative HPV ctDNA tests within 2-6 weeks after surgery
- At least one qualifying pathologic feature for Arm A or Arm B treatment groups
- Signed informed consent by participant or legal representative
- Adequate blood, kidney, and liver function for Arm B participants
- Negative pregnancy test for women of childbearing potential within 14 days prior to registration
You will not qualify if you...
- Metastatic disease
- Non-HPV16 HPV genotypes
- Surgery performed outside approved institutions without PI approval
- Prior head and neck radiation therapy
- Pre-operative HPV ctDNA less than or equal to 50 copies/mL or not available
- Simultaneous primary cancers outside the oropharynx (exceptions possible)
- Prior invasive malignancy unless disease-free for 3 years or high cure rate
- Prior systemic chemotherapy for the current cancer
- Severe active co-morbidities including recent heart failure, myocardial infarction, infections, respiratory illness, or liver failure
- Inability to understand or consent to the study and complete questionnaires
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 6 weeks post-surgery
Participants undergo HPV ctDNA testing and MRI studies to monitor for minimal residual disease after surgery.
Multiple visits for blood testing and imaging
Duration - Radiation administered over several weeks as per protocol
Participants receive adjuvant radiation therapy, either standard or de-escalated with concurrent chemotherapy, based on their HPV ctDNA results and pathology.
Weekly visits for radiation and chemotherapy treatments
Duration - Up to 2 years
Participants complete questionnaires to evaluate quality of life and financial toxicity after treatment.
Scheduled follow-up visits for assessments
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
N
Nancy Lee, MD
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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