Actively Recruiting
A Phase II Study for p16+ Oropharyngeal Cancer Personalized De-escalation Treatment at University of Michigan
Led by University of Michigan Rogel Cancer Center · Updated on 2026-02-02
150
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating personalized, less intensive treatment approaches for patients with early-stage (Stage I-II) p16 positive oropharyngeal cancer, a type of throat cancer linked to HPV. This Phase II study compares two treatment plans: surgery followed by either observation or tailored radiation and chemotherapy, and a customized chemoradiation approach. The goal is to find effective treatments that might reduce side effects while controlling cancer growth. In one group, patients undergo surgery to remove the tumor and affected lymph nodes, followed by risk-based additional treatments such as observation, radiation, or chemoradiation depending on surgical findings. In the other group, patients receive a planned course of chemoradiation starting with 30 Gy radiation over 15 sessions, adjusted mid-treatment based on PET/CT scans, with the total radiation dose ranging up to 70 Gy. Radiation is delivered five days a week. Each treatment plan is tailored to the patient's cancer characteristics. Participants will be closely monitored through clinical exams, imaging like PET/CT scans, and blood tests before and during treatment. Researchers will assess outcomes including cancer recurrence in the local and regional areas over two years, overall survival, disease progression, and treatment side effects both shortly after treatment and up to two years later. This study requires about two years of follow-up to evaluate treatment effects and safety.
CONDITIONS
Brief 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 must have FDG-avid (maximum SUV 64 4.0) and histologically or cytologically confirmed p16 positive or HPV positive squamous cell carcinoma of the oropharynx or unknown primary
- Clinical stage I or II according to AJCC 8th edition
- No distant metastases based on diagnostic workup including history, physical exam, and imaging
- Zubrod Performance Status 0-1 within 4 weeks prior to registration
- Age 18 years or older
- Able to tolerate required PET/CT imaging
- For surgical cohort, tumors must be potentially resectable via transoral approach with 0-2 clinically positive lymph nodes
- Adequate blood counts and bone marrow function within 4 weeks prior to registration
- Normal or acceptable kidney function with creatinine clearance 64 45 ml/min
- Women of childbearing potential and men must agree to use effective birth control during treatment
- Provide informed consent prior to study entry
You will not qualify if you...
- Clinical stage cT4, cN3, or cM1 disease
- Radiographic extracapsular extension or matted lymph nodes
- Prior invasive malignancy unless disease free for at least 3 years
- Any prior therapy for the current study cancer
- Prior radiotherapy overlapping study cancer region
- History of severe allergic reactions to paclitaxel, carboplatin, or platinum-containing products
- Severe active medical conditions including unstable angina, recent heart attack, severe infections, COPD exacerbation, AIDS, hepatic insufficiency, severe bone marrow depression, or significant bleeding
- Pregnancy or unwillingness to use contraception
- Poorly controlled diabetes for chemoradiation cohort
- Active enrollment in another clinical trial with active cancer treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day for surgery plus recovery period
Participants undergo initial surgical resection of the primary tumor and neck dissection. Pathologic features from surgery direct subsequent treatment decisions.
1 hospital visit for surgery plus follow-up visits as needed
Duration - Radiation and chemoradiation delivered over several weeks depending on assigned treatment
Participants receive risk-adjusted adjuvant treatment based on surgical pathology, which may include observation, post-operative radiation, or chemoradiation.
Radiation: Daily visits, 5 days per week for 4 to 6 weeks; Chemoradiation: same radiation schedule with concurrent chemotherapy
Duration - Up to 2 years post treatment
Participants are monitored for recurrence, survival outcomes, and potential late toxicities after completion of treatment.
Regular follow-up visits over 2 years
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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