Phase II Personalized De-escalation Treatment Study for p16 Oropharyngeal Cancer at University of Michigan

What this Trial Is About

Researchers are evaluating personalized, less intensive treatment approaches for patients with early-stage Stage I-II p16 positive oropharyngeal cancer, a type of throat cancer linked to HPV. This Phase II study compares two treatment plans surgery followed by either observation or tailored radiation and chemotherapy, and a customized chemoradiation approach. The goal is to find effective treatments that might reduce side effects while controlling cancer growth. In one group, patients undergo surgery to remove the tumor and affected lymph nodes, followed by risk-based additional treatments such as observation, radiation, or chemoradiation depending on surgical findings. In the other group, patients receive a planned course of chemoradiation starting with 30 Gy radiation over 15 sessions, adjusted mid-treatment based on PETCT scans, with the total radiation dose ranging up to 70 Gy. Radiation is delivered five days a week. Each treatment plan is tailored to the patients cancer characteristics. Participants will be closely monitored through clinical exams, imaging like PETCT scans, and blood tests before and during treatment. Researchers will assess outcomes including cancer recurrence in the local and regional areas over two years, overall survival, disease progression, and treatment side effects both shortly after treatment and up to two years later. This study requires about two years of follow-up to evaluate treatment effects and safety.

A Phase II Study for p16+ Oropharyngeal Cancer PerSonalized De-escalation Treatment at University of MIchigan (CuSToMIze)