Study on Lowering Radiation Dose for HPV-Positive Throat Cancer

Sponsor: Sara Medek

Sponsor score: 0

ClinicalTrials ID:NCT07497607

Provider View

This clinical trial is exploring whether reducing the radiation dose to areas without visible cancer can be as effective as the standard dose for treating HPV-positive throat cancer, while potentially reducing side effects.

Patient Parameters

Program Overview

The study aims to find out if lowering the radiation dose to areas without visible cancer in patients with HPV-positive oropharyngeal cancer can be as effective as the standard treatment. The radiation dose to visible cancer remains the same. Researchers hope that a lower dose could help treat the cancer effectively while reducing side effects and improving quality of life. Patients will continue to receive the usual chemotherapy drug, cisplatin, during radiation therapy.

Description

This research is focused on determining if a lower dose of radiation to areas without visible cancer can be as effective as the standard dose for treating HPV-positive oropharyngeal cancer. The standard treatment can have significant side effects, and researchers believe that reducing the dose from 46-54 Gy to 30 Gy in areas without visible cancer might be just as effective, with fewer side effects. This approach is not yet the standard of care, but it could improve patients' quality of life. Patients will still receive the standard chemotherapy drug, cisplatin, during radiation therapy.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with squamous cell carcinoma of the oropharynx (throat) and planned for chemoradiation treatment.
  • Cancer must be confirmed as HPV-positive (p16 positive).
  • Cancer must be at a specific stage (T1-4N1-3M0 or T3-T4N0M0) according to medical guidelines.
  • Must have measurable cancer based on recent PET/CT scans.
  • Must be 18 years or older.
  • Must have a performance status score of 2 or less, indicating good overall health.
  • Must be eligible for standard chemotherapy with cisplatin.
  • Women and men must agree to use effective birth control during the study.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Have cancer that has spread or returned.
  • Have cancer of unknown origin in the neck.
  • Have had previous radiation that overlaps with the current treatment area.
  • Are pregnant, nursing, or planning to have children during the study.
  • Have active autoimmune or connective tissue diseases requiring treatment.
  • Are receiving other experimental treatments.
  • Have uncontrolled illnesses or conditions that make participation unsafe.

Locations

FACILITYZIPCITYSTATE
University of Cincinnati Medical Center45219CincinnatiOhio

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