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 te

Trial Details

NCT ID
NCT06088381
Phase
PHASE2
Sponsor
University of Maryland, Baltimore
Status
RECRUITING
Cancer Type
HPV Positive Head and Neck Cancer
Interventions
  • Experimental Observation
  • Observation per Standard of Care
  • Adjuvant Treatment per Standard of Care
  • Circulating Tumor DNA test (ctDNA test)
Locations (sample)
  • Baltimore, Maryland, United States|39.29038,-76.61219
  • Baltimore, Maryland, United States|39.29038,-76.61219
  • Bel Air, Maryland, United States|39.53594,-76.34829
  • Columbia, Maryland, United States|39.24038,-76.83942
  • Glen Burnie, Maryland, United States|39.16261,-76.62469

Key Eligibility Criteria

  • Is there pathologically (histologically or cytologically) proven diagnosis of p16+ squamous cell carcinoma (including the histological variants pap…
  • Does the patient have clinical stage T0-3, N0-N1, and M0 disease (AJCC 8th edition) as defined by physical examination and appropriate imaging (PET…
  • Has the patient completed a ctDNA evaluation with results demonstrating positive ctDNA levels prior to surgery either in blood or on biopsy tissue?
  • Upon multi-disciplinary review, is the patient a candidate for TORS based on evaluation by ear, nose, throat (ENT) and review at multi-disciplinary…

For full eligibility, visit ClinicalTrials.gov.

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