Phase II Study of Lower Dose Radiation Guided by Circulating Tumor DNA in HPV-positive Oropharyngeal Cancer

What this Trial Is About

Researchers are evaluating how well using circulating tumor DNA to guide lower dose radiation therapy works for patients with human papillomavirus HPV-associated oropharyngeal cancer. This phase II trial compares the effects of reduced dose radiation combined with chemotherapy to the usual standard dose chemotherapy in patients who clear HPV particles from their blood. The goal is to assess tumor response and side effects with this adaptive treatment approach. Participants receive external beam radiotherapy 5 days a week for 4 weeks along with weekly or every 3 weeks chemotherapy using cisplatin, carboplatin, or paclitaxel. Blood samples are collected at week 4 to measure tumor DNA levels, and patients are assigned to one of two groups based on whether their tumor DNA has reduced by more than 95%. Those with reduced tumor DNA receive radiation for 5 weeks and chemotherapy for 5 weeks, while those without receive radiation and chemotherapy for 7 weeks. PETCT scans and blood tests are done throughout the trial. During the study, participants undergo regular PETCT imaging, blood sample collections, and complete questionnaires about swallowing function. After treatment, patients are followed every 3 months for up to 2 years to monitor tumor response, progression-free survival, and side effects. Researchers track acute and long-term toxicities and quality of life measures to understand the impact of the adaptive lower dose therapy compared to standard care.

Adaptive De-intensified Radiotherapy Using Circulating Tumor DNA in HPV- Associated Oropharyngeal Cancer