A Phase II Study for p16+ Oropharyngeal Cancer PerSonalized De-escalation Treatment at University of MIchigan (CuSToMIze)
University of Michigan Rogel Cancer Center
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- ProcedureSurgery
Cohort A will undergo initial surgical resection of the primary and neck dissection with pathologic features directing predetermined adjuvant treatment. Pathology of the primary and nodal specimens will then be reviewed as to determine the next intervention per protocol. Based on operative findings including degree of nodal involvement, extracapsular spread, perineural invasion, and lymphovascular involvement, patients will be designated to adjuvant treatment arms consisting of observation, adjuvant radiation, or adjuvant chemoradiation.
- Combination ProductChemoradiation
Patients will receive an initial plan with a single prescription of 30 Gy in 15 fractions to PTV\_High and PTV\_Low with RT given once daily, 5 days a week (Monday through Friday). After analysis of mid-treatment PET/CT, the remaining radiation treatment will be delivered as a conedown to the gross disease only. Patients will be planned to receive a total dose of 70 Gy, 54 Gy, or 44 Gy to PTV\_High in 2 Gy per fraction.
- OtherObservation
Cohort A will undergo initial surgical resection of the primary and neck dissection with pathologic features directing predetermined adjuvant treatment. Pathology of the primary and nodal specimens will then be reviewed as to determine the next intervention per protocol. Based on operative findings including degree of nodal involvement, extracapsular spread, perineural invasion, and lymphovascular involvement, patients will be designated to adjuvant treatment arms consisting of observation, adjuvant radiation, or adjuvant chemoradiation.
- RadiationPost-operative radiation
Location
- University of Michigan Rogel Cancer CenterAnn Arbor, Michigan