Phase II Study for Personalized Treatment of p16+ Oropharyngeal Cancer at University of Michigan (CuSToMIze)

Sponsor: University of Michigan Rogel Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05894083

Provider View

This study is exploring personalized treatment options for patients with early-stage p16+ oropharyngeal cancer. Participants will receive either surgery followed by observation or tailored radiation therapy, or a customized combination of chemotherapy and radiation.

Patient Parameters

Program Overview

This clinical trial is focused on finding the best personalized treatment for patients with Stage I-II p16+ oropharyngeal cancer. The study is being conducted at the University of Michigan and involves two treatment approaches: one involves surgery followed by observation or radiation therapy based on risk, and the other involves a personalized combination of chemotherapy and radiation therapy.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with squamous cell carcinoma of the oropharynx (such as tonsil or base of tongue) that is p16 positive or HPV positive.
  • Cancer is at Stage I-II according to the AJCC 8th edition.
  • No cancer spread to distant parts of the body.
  • Must have a PET scan showing active cancer.
  • Must be 18 years or older.
  • Must be able to undergo PET/CT imaging.
  • For surgical candidates, tumors must be removable through the mouth.
  • Must have adequate blood cell counts and kidney function.
  • Women and men must agree to use effective birth control during the study.
  • Must provide informed consent to participate.

Exclusion Criteria

  • Cancer at Stage 3 or 4, or with certain advanced features.
  • Previous invasive cancer unless disease-free for at least 3 years.
  • Previous treatment for the current cancer.
  • Previous radiation in the same area that would overlap with study treatment.
  • Severe health conditions like recent heart attack or severe infections.
  • AIDS or severe liver problems.
  • Pregnant or not willing to use birth control.
  • Poorly controlled diabetes for certain participants.
  • Enrolled in another active treatment clinical trial for the same cancer.

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