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

No results posted yet for this study

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04667585 on ClinicalTrials.gov