Personalized Treatment Using HPV Blood Test to Guide Radiation and Chemotherapy in HPV-Positive Oropharyngeal Cancer

What this Trial Is About

Researchers are evaluating a tailored treatment approach for participants with HPV-related oropharyngeal cancers by combining clinical features such as tumor stage and smoking status with an investigational HPV blood test called NavDx4 HPV ctDNA testing. This Phase II clinical trial aims to study whether adjusting radiation and chemotherapy doses based on these factors can improve treatment for this cancer type. Radiation therapy alone or with chemotherapy is a standard treatment, but the study investigates lowering doses for certain participants with favorable clinical and blood test results. Participants will undergo NavDx HPV ctDNA blood testing at various points to measure circulating tumor DNA levels. Depending on risk classification from the test and clinical features, participants will receive radiation therapy at either a lower dose for 5-6 weeks or the standard dose for 7-8 weeks. Some participants may also receive chemotherapy drugs like Cisplatin, Carboplatin, or Paclitaxel, with dosing schedules varying such as bolus Cisplatin every 21 days or weekly infusions during radiation. The treatment period lasts up to 7 weeks. Throughout the study, participants will be screened for eligibility, receive treatment, and attend evaluations and follow-up visits. Blood samples for the HPV ctDNA test will be collected before, during, and after treatment at scheduled intervals up to 5 years. Researchers will monitor progression-free survival at 2 years as the primary outcome, along with overall survival, rates of distant failure, treatment response, quality of life, and safety over time. The total study participation may last several years, with ongoing assessments to understand long-term outcomes and treatment impact.

Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study