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

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).

Trial Details

NCT ID
NCT05894083
Phase
PHASE2
Sponsor
University of Michigan Rogel Cancer Center
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • Surgery
  • Chemoradiation
  • Observation
  • Post-operative radiation
Locations (sample)
  • Ann Arbor, Michigan, United States|42.27756,-83.74088

Key Eligibility 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 c…
  • 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 full eligibility, visit ClinicalTrials.gov.

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