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OncoMatch/Clinical Trials/NCT06088381

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

Is NCT06088381 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies non-drug interventions for head and neck cancer.

Phase 2RecruitingUniversity of Maryland, BaltimoreNCT06088381Data as of May 2026

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.

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Biomarker criteria

Required: CDKN2A overexpression (p16+)

p16+ squamous cell carcinoma

Disease stage

Required: Stage T0-3, N0-N1 (AJCC 8th edition)

clinical stage T0-3, N0-N1, and M0 disease (AJCC 8th edition)

Performance status

ZUBROD 0–1

Prior therapy

Cannot have received: systemic chemotherapy

Exception: prior chemotherapy for a different cancer is allowable

prior systemic chemotherapy for the study cancer

Cannot have received: radiation therapy

prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields

Cannot have received: surgery

Exception: excluding superficial removal of cutaneous skin malignancies

prior cancer related surgeries of the head and neck excluding superficial removal of cutaneous skin malignancies

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Maryland Proton Treatment Center · Baltimore, Maryland
  • University of Maryland Greenebaum Cancer Center · Baltimore, Maryland
  • Upper Chesapeake Health · Bel Air, Maryland
  • Central Maryland Radiation Oncology · Columbia, Maryland
  • Baltimore Washington Medical Center · Glen Burnie, Maryland

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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