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 standard radiation dose.
The results of the interim PET-CT scan will be used guide your radiation dose plan. Depending on the PET-CT results, you will either received a reduced radiation dose or the standard radiation dose for your cancer.
The results of the interim PET-CT scan will be used guide your radiation dose plan. Depending on the PET-CT results, you will either received 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
-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?
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
-Get either a reduced dose or a standard dose of radiation based on your second PET-CT 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 where we will ask you about:
--Radiation treatment side effects
--Mucositis (sore mouth)
--Quality of life (questionnaires)
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, NC and the rest of your standard medical care will be with your regular doctor at Duke Raleigh Hospital.
-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
-Get either a reduced dose or a standard dose of radiation based on your second PET-CT 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 where we will ask you about:
--Radiation treatment side effects
--Mucositis (sore mouth)
--Quality of life (questionnaires)
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, NC 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 ACCRUAL