New blood test to reduce radiation in HPV-related throat cancer treatment
A Single Arm Phase II Trial Evaluating Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL)
This study is testing a new blood test to see if it can help identify patients with HPV-related throat cancer who might not need radiation after surgery, aiming to reduce side effects while keeping survival rates high.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 61 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 5 sites (Baltimore, Maryland and 4 other locations) |
| Trial ID | NCT06088381 on ClinicalTrials.gov |
What this trial studies
This clinical research evaluates the effectiveness of a blood test that measures circulating tumor DNA (ctDNA) levels in patients with HPV-positive oropharyngeal squamous cell carcinoma. The study aims to determine if using ctDNA levels can help identify patients who may not need radiation therapy after surgery, thereby reducing treatment-related side effects. Patients will undergo blood tests before and after surgery to monitor ctDNA levels, which are linked to cancer recurrence. The goal is to maintain high survival rates while minimizing the adverse effects of treatment.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with p16-positive oropharyngeal squamous cell carcinoma who meet specific clinical staging criteria.
Not a fit: Patients with advanced disease stages or those without a confirmed diagnosis of p16-positive squamous cell carcinoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for radiation therapy, leading to fewer side effects for patients.
How similar studies have performed: Previous studies have shown promise in using ctDNA as a biomarker for monitoring cancer, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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)?
Where this trial is running
Baltimore, Maryland and 4 other locations
- Maryland Proton Treatment Center — Baltimore, Maryland, United States (Recruiting)
- University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States (Recruiting)
- Upper Chesapeake Health — Bel Air, Maryland, United States (Not_yet_recruiting)
- Central Maryland Radiation Oncology — Columbia, Maryland, United States (Not_yet_recruiting)
- Baltimore Washington Medical Center — Glen Burnie, Maryland, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Jason K Molitoris, MD, PhD — University of Maryland/Maryland Proton Treatment Center
- Study coordinator: Jason K Molitoris, MD, PhD
- Email: jmolitoris@umm.edu
- Phone: 410-328-6080
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.