Study on Personalized Radiation Therapy for High-Risk HPV-Related Throat Cancer

Sponsor: University of Michigan Rogel Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06234748

Provider View

This clinical trial is exploring a new approach to radiation therapy for patients with high-risk HPV-related throat cancer. The study aims to see if using advanced imaging techniques can improve treatment outcomes while maintaining or reducing side effects compared to traditional methods.

Patient Parameters

Program Overview

The purpose of this study is to investigate whether personalized radiation therapy, guided by advanced imaging techniques like DCE MRI and FDG-PET, can be effectively used to treat high-risk HPV-related throat cancer. The goal is to enhance the radiation treatment specifically for patients with high-risk p16+ oropharyngeal cancer, potentially improving outcomes while keeping side effects similar to or less than those of standard treatments.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced p16+ squamous cell carcinoma of the oropharynx and referred for chemo-radiation therapy.
  • Classified as Stage III (cT4 or N3) according to AJCC 8.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Meet specific blood test criteria within four weeks before joining the study, including:
    • White blood cell count over 3500/ul.
    • Granulocyte count over 1500/ul.
    • Platelet count over 100,000/ul.
    • Total Bilirubin less than 1.5 times the upper limit of normal.
    • AST and ALT less than 2.5 times the upper limit of normal.
    • Creatinine clearance over 30cc/min.
  • Able to receive chemotherapy as determined by the treating oncologist.
  • Aged 18 or older.
  • Must understand the study is experimental and provide written consent.
  • Women of childbearing potential and men must agree to use effective birth control during the study.

Exclusion Criteria

  • Pregnant women or those not willing to use effective contraception, as the treatment may harm an unborn baby.
  • Unable to undergo MRI or PET scans with contrast due to medical reasons.
  • Have had another invasive cancer within the last 3 years, except for certain skin cancers or non-invasive cancers like carcinoma in situ.
  • Have received any prior treatment for the current cancer, although past chemotherapy for a different cancer is allowed if it was over 3 years ago.

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