Phase 2 Study of Using HPV ctDNA Testing to Guide Post-Surgery Radiation and Chemoradiation in HPV-Related Oropharynx Cancer

What this Trial Is About

Researchers are evaluating whether monitoring HPV circulating tumor DNA ctDNA levels can effectively detect the risk of cancer returning in people with HPV-associated oropharynx cancer HPV-OPC who have recently undergone or are scheduled for surgery. The study aims to determine if this monitoring can guide decisions about radiation therapy and chemotherapy, potentially allowing for delayed or reduced treatment. This is a Phase II trial sponsored by Memorial Sloan Kettering Cancer Center. Participants are divided into two groups. In Arm A, those with rising HPV ctDNA levels after surgery may have radiation therapy delayed until ctDNA becomes detectable, with radiation doses of 50-60 Gy planned. In Arm B, patients typically needing 6 to 6.5 weeks of chemoradiation may receive a shorter, 3-week course of radiation with concurrent chemotherapy. Both arms involve detailed imaging with FDG PETCT scans for treatment planning and to check for cancer spread. Throughout the study, participants will undergo blood tests to measure HPV ctDNA, imaging scans, and complete questionnaires assessing quality of life and financial impact. Researchers will track progression-free survival over two years, along with detailed monitoring of treatment effects. Treatment is personalized based on ctDNA results and pathology findings, with ongoing assessments for safety and effectiveness during follow-up visits.

A Study on Using Cell-Free Tumor DNA (ctDNA) Testing to Decide When to StartRoutine Treatment in People With Human Papilloma Virus (HPV)- Associated Oropharynx Cancer (OPC)