PET-CT for Dose Reduced Radiotherapy in HPV-positive Oral Cancer

Purpose of this Study

We are doing this study to understand whether people who receive a lower radiation dose after an interim (the second scan) PET-CT identifies an early treatment response have a similar outcome to those receiving a standard radiation dose. The results of the interim PET-CT scan will be used to guide your radiation dose plan. Depending on the PET-CT results, you will either receive a reduced radiation dose or the standard radiation dose for your cancer.

Who Can Participate?

Eligibility

Adults who:
  • Are diagnosed with oral cancer that is positive for Human Papilloma Virus (HPV+)
  • Are planning to have radiation therapy

    • Age Range

    18-110

    Sex/Genders

    Male (cisgender)
    Female (cisgender)
    Non-binary or gender fluid
    Transgender male
    Transgender female
    Looking for Healthy Participants
    No

    What is Involved?

    Description

    If you choose to join this study, you will have 2 PET scans in addition to computed tomography (CT) scans.
    • The first PET scan will be done with your standard CT scan for treatment planning before starting radiation therapy.
    • The second PET-CT scan will be about 2 weeks after starting radiation therapy to see how you are responding.
    • You will get either a reduced dose or a standard dose of radiation based on your second PET-CT scan results
    Everyone in the study will:
    • Be involved in the study for about 1 year
    • Have information collected from your medical record for about 2 years
    • Have follow up study visits
    This study is also available to patients at Duke Raleigh Hospital with eConsent. The 2 PET scans must be done at Duke Cancer Center in Durham, and the rest of your standard medical care will be with your regular doctor at Duke Raleigh Hospital.

    Locations

    Duke University Hospital
    Duke Raleigh Hospital

    Visit Timing

    Weekdays

    Compensation

    No

    Spanish Materials Available

    No

    Study Details

    Full Title

    Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx Using Metabolic Signature from Interim 18FDG-PET/CT

    Principal Investigator

    David
    Brizel

    Protocol Number

    PRO00105899

    NCT ID

    NCT04667585

    Phase

    II

    Enrollment Status

    Open to Enrollment
    ClinicalTrials.gov