Actively Recruiting
Selective Adjuvant Therapy for HPV-mediated Oropharynx Squamous Cell Carcinomas Based on Residual Circulating Tumor DNA Levels Phase II Trial
Led by University of Maryland, Baltimore · Updated on 2025-11-10
61
Participants Needed
5
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
People with human papillomavirus (HPV)-related oropharyngeal squamous cell carcinoma (p16+OPSCC) usually have good survival rates regardless of the treatment they receive. However, treatments like surgery and radiation can cause significant side effects, sometimes lasting long term. Because of this, the study aims to find ways to reduce these side effects while keeping excellent cancer outcomes. This research is a phase II trial evaluating whether a new blood test called a circulating tumor DNA (ctDNA) test can help guide treatment decisions and limit unnecessary radiation therapy. The study involves patients who are candidates for surgery using transoral robotic surgery (TORS). They will have their blood tested for ctDNA before and shortly after surgery. Based on ctDNA results and surgical findings, patients will be grouped into low, intermediate, or high risk categories. Low-risk patients will be observed without radiation following standard care. Intermediate-risk patients with negative post-surgery ctDNA will be observed without radiation as part of the experimental approach. High-risk patients will receive radiation therapy with or without chemotherapy according to usual care. The study also includes regular ctDNA monitoring after treatment. Participants will be closely monitored through physical exams, imaging, and blood tests to check for cancer recurrence and side effects. Researchers will track progression-free survival over two years and assess quality of life, swallowing function, and side effects like dry mouth. If cancer recurs, salvage treatments such as surgery or radiation may be offered. The study aims to understand if ctDNA-guided treatment can reduce harmful side effects while maintaining cancer control over the long term.
CONDITIONS
Brief Title
Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed p16-positive squamous cell carcinoma of the oropharynx or p16-positive squamous cell carcinoma unknown primary
- Clinical stage T0-3, N0-N1, M0 disease based on imaging within 60 days of enrollment
- Positive circulating tumor DNA (ctDNA) test prior to surgery
- Candidate for transoral robotic surgery (TORS) as determined by ENT and tumor board
- General history and physical examination by appropriate specialist within 60 days before registration
- Zubrod Performance Status of 0-1 within 30 days before registration
- Age 18 years or older
- Willingness to use effective contraception if sexually active during treatment and for 180 days after
- Provided study-specific informed consent including tissue submission for p16 review
You will not qualify if you...
- Cancer originating from oral cavity, nasopharynx, hypopharynx, or larynx
- Presence of distant metastasis
- Prior invasive cancer unless disease-free for at least 3 years (exceptions for certain skin and prostate cancers)
- Previous systemic chemotherapy for this cancer
- Prior radiation overlapping study cancer region
- Prior head and neck cancer surgeries excluding superficial skin tumor removal
- Co-morbid conditions or concerns interfering with follow-up
- Active drug or alcohol dependency limiting compliance
- Pregnant or nursing (except nursing patients not receiving chemotherapy)
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) for eligibility assessment including ctDNA testing before surgery
Duration - Up to 2 weeks
Participants undergo transoral robotic surgery (TORS) to remove the tumor. Post-operative ctDNA testing is performed within 2-14 days after surgery to assess residual disease.
1 surgery visit and 1 post-operative visit for ctDNA blood test
Duration - Duration varies by treatment regimen
Participants in the high-risk group receive adjuvant radiation therapy, with or without chemotherapy, based on standard of care. Intermediate and low-risk groups are observed without radiation.
Radiation visits and chemotherapy visits as per standard of care for high-risk participants; no treatment visits for observation groups
Duration - 2 years after treatment completion
All participants are monitored for recurrence, toxicity, quality of life, and outcomes with regular ctDNA testing every 3 months (except at 21 months) for 2 years after completion of initial or salvage therapy.
Quarterly visits for ctDNA testing and assessments over 2 years
Trial Site Locations
Total: 5 locations
1
Maryland Proton Treatment Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
2
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
3
Upper Chesapeake Health
Bel Air, Maryland, United States, 21014
Not Yet Recruiting
4
Central Maryland Radiation Oncology
Columbia, Maryland, United States, 21044
Not Yet Recruiting
5
Baltimore Washington Medical Center
Glen Burnie, Maryland, United States, 21061
Not Yet Recruiting
Research Team
J
Jason K Molitoris, MD, PhD
K
Kelly Kitzmiller, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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