Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx
NCT04667585 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2026-02-27
Summary
The purpose of this study is to use intra-treatment 18FDG-PET/CT during definitive radiation therapy for human papillomavirus (HPV)-related oropharyngeal cancer (OPC) as an imaging biomarker to identify and select patients with a favorable response for chemoradiation dose de-escalation. This study will prospectively evaluate the clinical outcomes for patients undergoing dose de-escalation.
Conditions
- Oropharynx Cancer
Interventions
- RADIATION
-
De-escalated radiation dose
Reduced dose of radiation applied to remaining radiation therapy when favorable interim PET-CT signature is produced
- RADIATION
-
Standard radiation dose
Standard dose of radiation applied to remaining radiation therapy when favorable PET-CT signature is not produced
- OTHER
-
18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT)
The CT scan - also called computerized tomography or just CT - combines a series of X-ray views taken from many different angles to produce cross-sectional images of the bones and soft tissues inside the body. CT scans in planning radiation therapy are standard of care. A PET is a highly specialized imaging technique that uses short-lived radioactive substances (such as FDG a simple sugar labeled with a radioactive atom) to produce three-dimensional colored images of those substances functioning within the body. These images are called PET scans and the technique is termed PET scanning. PET scanning provides information about the body's chemistry not available through other procedures. Unlike CT or MRI (magnetic resonance imaging), techniques that look at anatomy or body form, PET studies metabolic activity or body function.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Jared Robbins, MD · DUHS
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-12
- Primary Completion
- 2028-01-31
- Completion
- 2028-01-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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