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Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL)

NCT06088381 · University of Maryland, Baltimore · Updated 10 Nov 2025

What is being tested
Experimental Observation; Observation per Standard of Care; Adjuvant Treatment per Standard of Care; Circulating Tumor DNA test (ctDNA test)
For
Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma; Oropharynx Cancer; Oropharynx Squamous Cell Carcinoma; HPV Positive Oropharyngeal Squamous Cell Carcinoma
Kind of study
Tests a treatment or device on volunteers. Phase 2.
Who can join
Ages 18 years and older. About 61 people. The full rules are on the registry page.
Where
United States (5 sites)
When
Starts or started 7 March 2024, ends 18 Dec 2030. Registered 18 Oct 2023.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT06088381

Sites

  • Maryland Proton Treatment CenterBaltimore, Maryland, United States
  • University of Maryland Greenebaum Cancer CenterBaltimore, Maryland, United States
  • Upper Chesapeake HealthBel Air, Maryland, United States
  • Central Maryland Radiation OncologyColumbia, Maryland, United States
  • Baltimore Washington Medical CenterGlen Burnie, Maryland, United States