Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL) (NCT06088381)
A Single Arm Phase II Trial Evaluating Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Maryland Proton Treatment Center — Baltimore, Maryland
Age range: 18 Years
🧪 Interventions in This Study
- Experimental Observation (OTHER)
- Observation per Standard of Care (OTHER)
- Adjuvant Treatment per Standard of Care (RADIATION)
- Circulating Tumor DNA test (ctDNA test) (DIAGNOSTIC_TEST)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (5 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
📞 Contact the Study Coordinator
Phone: (410) 328-6080
Email: jmolitoris@umm.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Head and Neck Cancer
- Window Study of Nivolumab With or Without Ipilimumab in Squamous Cell Carcinoma of the Oral Cavity — Boston, Massachusetts
- Imaging With a PET Agent for Detection of Cancers of the Head and Neck — New York, New York
- Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Head and Neck Cancer — Miami, Florida
- ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy — Miami, Florida
- ASP-1929 Photoimmunotherapy (PIT) Study in Patients With Recurrent Head/Neck Cancer — Bethesda, Maryland
- "QUAD SHOT" Radiotherapy With Pembrolizumab in Patients With Recurrent Head & Neck Cancer — Oklahoma City, Oklahoma
Explore by condition: All Head and Neck Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.