Phase II Study of Personalized Radiation Therapy Using Blood Biomarkers for HPV-Positive Oropharyngeal Cancer

What this Trial Is About

Researchers are studying human papillomavirus HPV positive oropharyngeal squamous cell cancers to evaluate if a blood-based biomarker test, using the NavDx device, can guide decisions on radiation and chemotherapy treatments. This Phase II trial aims to balance reducing treatment side effects with lowering the chances of cancer recurrence. The study involves patients with head and neck cancers who undergo standard treatments like surgery, radiation, and chemotherapy, monitoring how the biomarker may help in early detection and treatment adjustment. Participants are assigned to one of four groups based on their risk and treatment plans. Group 1 follows observation after surgery with regular scans and swallow studies. Group 2 receives diffusing alpha-emitter radiation therapy DART with docetaxel alongside scheduled imaging and sample collections. Group 3 undergoes intensity-modulated radiation therapy IMRT or proton therapy IMPT with or without cisplatin chemotherapy. Group 4 gets IMRT or IMPT with concurrent cisplatin, with treatment intensity adjusted by biomarker response. All groups have detailed schedules for scans, swallow studies, and blood and saliva sample collections at various timepoints. During the study, participants undergo multiple evaluations including imaging CT, PETCT, MRI, modified barium swallow studies, and blood and saliva collections for NavDx biomarker testing. Follow-up visits occur frequently after treatment completion, with monitoring extending up to five years for progression-free survival, disease recurrence, survival rates, patient-reported outcomes, treatment side effects, functional outcomes, return to work, and cost assessments. This thorough monitoring aims to understand treatment impacts and the biomarkers role in guiding therapy and detecting recurrence early.

De-Escalated Adjuvant and Definitive Radiation Therapy Informed by DART 2.0 ctHPV-DNA