A Phase II Study for p16+ Oropharyngeal Cancer PerSonalized De-escalation Treatment at University of MIchigan (CuSToMIze)
Trial Parameters
Brief Summary
Single center, non-randomized Phase II study enrolling Stage I-II p16+ oropharyngeal cancer patients to one of two de-escalation treatment paradigms: (1) receive surgery followed by observation or risk-adjusted adjuvant radiation (+/-chemo), or (2) individualized adaptive definitive chemoradiation (CRT).
Eligibility Criteria
Inclusion Criteria: * Patients must have FDG-avid (maximum SUV ≥ 4.0) (from PET scan of any date, any scanner) and histologically or cytologically proven squamous cell carcinoma of the oropharynx (tonsil, base of tongue, oropharyngeal wall, soft palate) or unknown primary that is p16 positive by immunohistochemistry or HPV positive by in situ hybridization * Clinical stage: Stage I-II AJCC 8th edition staging * Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup: * History/physical examination, including documentation of weight within 4 weeks prior to registration; * For Cohort B, FDG-PET/CT scan for staging within 6 weeks prior to registration. For Cohort A, acceptable imaging for staging can include diagnostic CT neck/chest or PET-CT within 6 weeks prior to registration * Zubrod Performance Status 0-1 within 4 weeks prior to registration; * Age ≥ 18; * Able to tolerate PET/CT imaging required to be performed * For