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

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.

NCT Number	NCT06088381
Lead Sponsor	University of Maryland, Baltimore
Conditions	Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Oropharynx Cancer, Oropharynx Squamous Cell Carcinoma, HPV Positive Oropharyngeal Squamous Cell Carcinoma
Enrollment	61 participants
Start Date	2024-03-07
Primary Completion	2028-12-18 (estimated)
Study Completion	2030-12-18 (estimated)
Updated on ClinicalTrials.gov	2025-11-10