Actively Recruiting
A Phase II Study for p16+ Oropharyngeal Cancer PerSonalized De-escalation Treatment at University of MIchigan (CuSToMIze)
Led by University of Michigan Rogel Cancer Center · Updated on 2026-02-02
150
Participants Needed
1
Research Sites
396 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Phase II Study for p16+ Oropharyngeal Cancer PerSonalized De-escalation Treatment at University of MIchigan (CuSToMIze)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with FDG-avid (SUV 4.0) and histologically or cytologically confirmed p16 positive or HPV positive squamous cell carcinoma of the oropharynx or unknown primary
- Clinical stage I-II based on AJCC 8th edition with no distant metastases
- History and physical exam including weight documented within 4 weeks prior to registration
- For Cohort B, FDG-PET/CT scan within 6 weeks prior to registration; for Cohort A, diagnostic CT neck/chest or PET-CT within 6 weeks prior to registration
- Zubrod Performance Status of 0-1 within 4 weeks prior to registration
- Age 18 years or older
- Able to tolerate PET/CT imaging as required
- For Cohort A, tumors must be potentially resectable by transoral surgery with 0-2 clinically positive lymph nodes
- Complete blood count within 4 weeks prior to registration with adequate bone marrow function (ANC 1,500 cells/mm3, platelets 100,000 cells/mm3, hemoglobin 8.0 g/dL)
- Serum creatinine within normal limits or creatinine clearance 45 ml/min within 4 weeks prior to registration
- Women of childbearing potential and male participants must agree to use effective birth control during treatment
- Provide study-specific informed consent prior to entry
You will not qualify if you...
- Clinical stage cT4, cN3, or cM1 disease
- Radiographic extracapsular extension or matted lymph nodes
- Prior invasive cancer within 3 years except non-melanoma skin cancer
- Any prior treatment for the current study cancer
- Prior radiation overlapping the study cancer region
- Allergic or hypersensitivity reactions to paclitaxel, carboplatin, platinum agents, or Cremophor EL
- Severe active illnesses including unstable angina, recent myocardial infarction, active infection requiring IV antibiotics, severe respiratory illness, AIDS, liver failure with jaundice or coagulation defects, severe bone marrow depression or bleeding
- Pregnancy or unwillingness/inability to use medically acceptable contraception
- For Cohort B, poorly controlled diabetes (fasting glucose > 200 mg/dL) despite management attempts
- Active participation in another clinical trial with active treatment for the study cancer
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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