Actively Recruiting
Adaptive De-intensified Radiotherapy Using Circulating Tumor DNA in HPV- Associated Oropharyngeal Cancer
Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-03-24
45
Participants Needed
1
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II trial studies how well using circulating tumor deoxyribonucleic acid (DNA) to guide lower dose radiation therapy works in treating patients with human papillomavirus infection (HPV)-associated oropharyngeal cancer. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Recently, a blood test has been developed to detect the human papillomavirus in the blood and determine how many viral particles are present. Researchers want to compare any good and bad effects of using the lower dose radiation therapy with chemotherapy compared to the usual standard of care dose chemotherapy in patients who clear the human papillomavirus particles from their blood.
CONDITIONS
Official Title
Adaptive De-intensified Radiotherapy Using Circulating Tumor DNA in HPV- Associated Oropharyngeal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed squamous cell carcinoma of the oropharynx
- P16 positive immunohistochemical staining confirmed
- Clinical stage T0, N1-N2, T1-2, N1-N2, or T3-T4, N0-2 with no distant metastases
- Measurable disease at primary site or lymph nodes
- Pretreatment PET/CT scan completed
- Tumor tissue modified HPV virus (TTMV-HPV) particles >= 200 copies/mL at baseline
- Smoking history <= 10 pack years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Age >= 18 years
- Absolute neutrophil count >= 1500/mcL within 14 days prior to registration
- Platelets >= 100,000/mcL within 14 days prior to registration
- Hemoglobin >= 8.0 g/dL within 14 days prior to registration
- Total bilirubin <= 1.5 x institutional upper limit of normal within 14 days prior to registration
- AST or ALT <= 3.0 x institutional upper limit of normal within 14 days prior to registration
- Serum creatinine <= 1.5 x institutional upper limit of normal or creatinine clearance >= 50 mL/min within 14 days prior to registration
- HIV infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months
- History of hepatitis C virus treated and cured
- Negative pregnancy test for women of childbearing potential within 14 days prior to registration
- Provided study specific informed consent prior to entry
You will not qualify if you...
- Recurrent disease
- Metastatic disease or adenopathy below the clavicles
- Cancers originating from the oral cavity
- Simultaneous primary cancers or separate bilateral primary tumors except bilateral tonsil cancers
- Prior invasive malignancy unless disease free for at least 3 years
- Prior systemic chemotherapy or immunotherapy
- Prior radiotherapy overlapping current radiation fields
- Severe active co-morbidity such as unstable angina or heart failure requiring hospitalization in last 6 months
- Systemic steroid or immunosuppressive treatment within 14 days of registration
- Active autoimmune disease requiring systemic treatment
- Pregnancy, nursing, or expecting to conceive
- Allergic to cisplatin, carboplatin, or paclitaxel
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Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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