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

Recruiting now · Phase 2

Conditions studied: Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Oropharynx Cancer, Oropharynx Squamous Cell Carcinoma, HPV Positive Oropharyngeal Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT06088381

Run by

University of Maryland, Baltimore

People needed

61

Starts

2024-03-07

Expected to finish

2030-12-18

Last updated by the study team

2025-11-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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?
• 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 tumor board?
• 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?
• Was the patient's Zubrod Performance Status 0-1 within 30 days prior to registration?
• Is the patient ≥ 18 years of age?
• 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.
• Did the patient provide study specific informed consent prior to study entry, including consent for mandatory submission of tissue for required p16 review?

You may not qualify if…

• 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?
• Does the patient have distant metastasis?
• 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?
• Did the patient have prior systemic chemotherapy for the study cancer (prior chemotherapy for a different cancer is allowable)?
• Did the patient have prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields?
• Did the patient have prior cancer related surgeries of the head and neck excluding superficial removal of cutaneous skin malignancies?
• Does the patient have any co-morbid condition or concern that may interfere with follow up per experimental arm?
• Does the patient have an active drug or alcohol dependency that in the opinion of the investigator would limit compliance with study requirements?
• Is the patient pregnant or nursing (an exception will be made for nursing patients that are not receiving chemotherapy)?

Where it is running

• Maryland Proton Treatment Center — Baltimore, Maryland, United States (enrolling)
• University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States (enrolling)
• Upper Chesapeake Health — Bel Air, Maryland, United States
• Central Maryland Radiation Oncology — Columbia, Maryland, United States
• Baltimore Washington Medical Center — Glen Burnie, Maryland, United States

Full record on ClinicalTrials.gov

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