A Pilot Study of Adaptive De-Intensified Radiotherapy Using Circulating Tumor DNA in HPV- Associated Oropharyngeal Cancer
Ohio State University Comprehensive Cancer Center
Summary
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.
Description
PRIMARY OBJECTIVE: I. To estimate the 3-month post-treatment positron emission tomography (PET) response rate in patients who have a favorable tumor tissue modified viral (TTMV) tumor profile (defined as \>= 200 copies/mL and reduced to \> 95% of this value by week 4). SECONDARY OBJECTIVES: I. To assess 2-year progression free survival and toxicity in the reduced dose chemo-radiation arm. II. To determine acute and late toxicity as measured by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v 5.0). III. To compare changes in the MD Anderson Dysphagia Inventory (MDADI) of…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Pathologically confirmed diagnosis of squamous cell carcinoma of the oropharynx (unknown primary, base of tongue, tonsil, oropharyngeal walls, soft palate). Cytologic or fine needle aspiration (FNA) confirmation is sufficient if a biopsy of the primary tumor is not feasible * P16 positive immunohistochemical staining. FNA may be used as the sole diagnostic tissue. If staining was done at an outside hospital, central review by the Ohio State University (OSU) department of pathology must occur prior to trial enrollment * Clinical stage T0, N1-N2, T1-2, N1-N2, T3-T4, N0-2 (…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- DrugCarboplatin
Given IV
- DrugCisplatin
Given IV
- ProcedureComputed Tomography
Undergo PET/CT
- RadiationExternal Beam Radiation Therapy
Undergo external beam radiotherapy
- DrugPaclitaxel
Given IV
- ProcedurePositron Emission Tomography
Undergo PET/CT
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio