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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT05894083
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Surgery — PROCEDURE
    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.
  • Chemoradiation — COMBINATION_PRODUCT
    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.
  • Observation — OTHER
    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.
  • Post-operative radiation — RADIATION
    Patients will receive adjuvant radiation based on pathologic features.Total radiation treatment doses and prescriptions will include 36 Gy in 18 fractions, 50 Gy in 25 fractions and 60 Gy in 30 fractions.

Study Details

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).

Key Dates

Start date
Apr 27, 2023
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2030

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Surgery
    Surgery followed by risk-adjusted adjuvant treatment (observation, radiation, or chemoradiation).
  • Experimental: Definitive CRT
    Risk-adjusted definitive chemoradiation.

Primary Outcome Measure

Loco-regional recurrence free survival (LR-RFS) rate [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan Rogel Cancer CenterAnn ArborMichigan48109
Cancer AnswerLine
[email protected]
800-865-1125
Michelle Mierzwa, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Ann Arbor, MI

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
University of Michigan Rogel Cancer Center· Ann Arbor, MI

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