NCT06088381 Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL)
| NCT ID | NCT06088381 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Maryland, Baltimore |
| Condition | Head and Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 61 participants |
| Start Date | 2024-03-07 |
| Primary Completion | 2028-12-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 61 participants in total. It began in 2024-03-07 with a primary completion date of 2028-12-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria 1. Is there pathologically (histologically or cytologically) proven diagnosis of p16+ squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx or p16+ squamous cell carcinoma unknown primary? Note: specimen from cervical lymph nodes with a well-defined primary site documented clinically or radiologically is acceptable; in patients with carcinoma of unknown primary this will be sufficient for pathologic confirmation without a clinically or radiographically defined primary site. 2. 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/CT preferred, CT neck with IV contrast with CT chest without contrast as recommended alternative to PET/CT) with imaging within 60 days of enrollment? 3. Has the patient completed a ctDNA evaluation with results demonstrating positive ctDNA levels prior to surgery either in blood or on biopsy tissue? 4. Upon multi-disciplinary review, is the patient a candidate for TORS based on evaluation by ear, nose, throat (ENT) and review at multi-disciplinary tumor board? 5. Was a general history and physical examination performed by a radiation oncologist, medical oncologist, or head and neck surgeon within 60 days prior to registration? 6. Was the patient's Zubrod Performance Status 0-1 within 30 days prior to registration? 7. Is the patient ≥ 18 years of age? 8. If a woman of child-bearing potential or sexually active male, is the patient willing to use effective contraception throughout their participation in the treatment phase of the study and at least 180 days following the last study treatment. 9. Did the patient provide study specific informed consent prior to study entry, including consent for mandatory submission of tissue for required p16 review? Exclusion Criteria 1. Does the patient have cancer considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), nasopharynx, hypopharynx, or larynx? 2. Does the patient have distant metastasis? 3. Does the patient have prior invasive malignancy (except non-melanomatous skin cancer and low/intermediate risk prostate cancer) unless disease free for a minimum of 3 years? 4. Did the patient have prior systemic chemotherapy for the study cancer (prior chemotherapy for a different cancer is allowable)? 5. Did the patient have prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields? 6. Did the patient have prior cancer related surgeries of the head and neck excluding superficial removal of cutaneous skin malignancies? 7. Does the patient have any co-morbid condition or concern that may interfere with follow up per experimental arm? 8. Does the patient have an active drug or alcohol dependency that in the opinion of the investigator would limit compliance with study requirements? 9. Is the patient pregnant or nursing (an exception will be made for nursing patients that are not receiving chemotherapy)?
Contact & Investigator
Jason K Molitoris, MD, PhD
PRINCIPAL INVESTIGATOR
University of Maryland/Maryland Proton Treatment Center
Frequently Asked Questions
Who can join the NCT06088381 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06088381 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06088381 currently recruiting?
Yes, NCT06088381 is actively recruiting participants. Contact the research team at jmolitoris@umm.edu for enrollment information.
Where is the NCT06088381 trial being conducted?
This trial is being conducted at Baltimore, United States, Baltimore, United States, Bel Air, United States, Columbia, United States and 1 additional location.
Who is sponsoring the NCT06088381 clinical trial?
NCT06088381 is sponsored by University of Maryland, Baltimore. The principal investigator is Jason K Molitoris, MD, PhD at University of Maryland/Maryland Proton Treatment Center. The trial plans to enroll 61 participants.
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