Trial of Individualized Adaptive RT in HPV-related High Risk Oropharynx Cancer

Sponsor: University of Michigan Rogel Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06234748

Patient View

This study evaluates the feasibility of using multi-modality imaging to optimize radiation therapy in high-risk p16+ oropharynx cancer. Eligible participants are adults with advanced squamous cell carcinoma, meeting specific health criteria. Interventions include adaptive radiation therapy and weekly platinum-based chemotherapy. Exclusions include pregnancy and prior invasive malignancy within 3 years.

Patient Parameters

Program Overview

This study seeks to study the population of HPV-related oropharynx cancer patients that appear to be at highest risk for treatment failure with loco-regional failure and distant metastases including cT4 or cN3. The study team aims to determine if it is feasible to use multi-modality imaging (both DCE MRI and FDG-PET) to optimize the radiation boost in high risk p16+ OPSCC with similar or decreased toxicity compared to historic standard therapy.

Eligibility Criteria

Inclusion Criteria

  • Patients must have pathologically confirmed, locally/regionally advanced p16+ squamous cell carcinoma of the oropharynx referred for definitive chemo-RT
  • AJCC 8 Stage III (cT4 or N3)
  • ECOG 0-1 performance status within two weeks of enrollment
  • Pre-treatment laboratory criteria within four weeks of enrolment: WBC > 3500/ul, granulocyte > 1500/ul. Platelet count > 100,000/ul. Total Bilirubin < 1.5 X ULN. AST and ALT < 2.5 X ULN. Estimated Creatinine clearance >30cc/min
  • Patients must be able to receive protocol chemotherapy in the judgment of the treating Medical Oncologist
  • Age >18
  • All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.
  • Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study.

Exclusion Criteria

  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
  • Patients should have no contraindications to having a contrast enhanced MRI scan. These contraindications will be assessed at the time of enrollment using the guidelines set up and in clinical use by the Institutional Standard Practice.
  • Patients should have no contraindications to having a contrast enhanced PET scan. These contraindications will be assessed at the time of enrollment using the guidelines set up and in clinical use by the Institutional Standard Practice.
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
  • Any prior therapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if > 3 years prior to study;

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