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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary completion date: Dec 2025 to Dec 2026
    • Study completion date: Dec 2029 to Dec 2030
    v6
  2. Primary completion date: Apr 2025 to Dec 2025
    • Study completion date: Apr 2029 to Dec 2029
    v5
  3. Eligibility criteria expanded, about 37 wordsv4
  4. Eligibility criteria expanded, about 54 wordsv3
  5. Re-verified, no change to tracked fieldsv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Number NCT05894083
Lead Sponsor University of Michigan Rogel Cancer Center
Conditions
(from sponsor)		 Oropharyngeal Cancer, Squamous Cell Carcinoma of the Oropharynx
Related terms Oropharyngeal Neoplasms, Squamous Cell Carcinoma of Head and Neck
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov