Actively Recruiting
Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL)
Led by University of Maryland, Baltimore · Updated on 2025-11-10
61
Participants Needed
5
Research Sites
353 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients with human papillomavirus (HPV)-related oropharyngeal cancer generally have favorable outcomes and how well they do depends on the specific details about the patient and their cancer. How well they do isn't as related to the kinds of treatment they get. However, there are significant side effects for the various types of treatments they may get. Because these patients generally have favorable outcomes no matter the kind of treatment, reducing side effects should be a priority when choosing their treatment. The goal of this clinical research study is to evaluate whether a new blood test called a Circulating Tumor DNA test (ctDNA test) can decrease the number of people that require radiation after surgery. This blood test is often elevated in people when they are diagnosed with head and neck cancer. There are studies that show that cancer most often returns when this blood test is positive after treatment. This study will test patients' blood before and after surgery. In cases where the test is negative after surgery, people on the study will not receive radiation unless they are considered high risk based on surgery findings. The hope is that radiation and its potential side effects can be limited to only people that need the treatment.
CONDITIONS
Official 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 unknown primary with cervical lymph node involvement
- Clinical stage T0-3, N0-N1, M0 disease based on physical exam and imaging within 60 days of enrollment
- Positive ctDNA levels before surgery from blood or biopsy tissue
- Candidate for transoral robotic surgery (TORS) confirmed by ENT and tumor board
- General history and physical exam completed by oncology specialist within 60 days prior to registration
- Zubrod Performance Status 0-1 within 30 days prior to registration
- Age 18 years or older
- Willingness to use effective contraception if of child-bearing potential during treatment and for 180 days after
- Provided 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 malignancy unless disease free for at least 3 years (except certain skin and prostate cancers)
- Prior systemic chemotherapy for the study cancer
- Prior radiation to the cancer region causing overlapping radiation fields
- Prior head and neck cancer surgeries except superficial skin removal
- Co-morbid conditions interfering with follow-up
- Active drug or alcohol dependency limiting study compliance
- Pregnant or nursing patients (except nursing patients not receiving chemotherapy)
AI-Screening
AI-Powered Screening
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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
CONTACT
K
Kelly Kitzmiller, MPH
CONTACT
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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