CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 120 target
Drug / intervention
De-escalated radiation dose +2 moreradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04667585
NCT04667585N/AActiveOn Track

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

Duke University·interventional·Posted Dec 14, 2020·Updated Jun 12, 2026

In Brief

A clinical study evaluating De-escalated radiation dose, Standard radiation dose, and 1 other intervention for Oropharynx Cancer. Active but no longer recruiting, targeting 120 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/AActive
20212022202320242025202620272028
First PostedDec 14, 2020
Enrollment StartApr 12, 2021
Primary CompletionJul 1, 2028
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 5.5 years agoPrimary completion in 2.0 years

Interventions

De-escalated radiation doseradiation

Reduced dose of radiation applied to remaining radiation therapy when favorable interim PET-CT signature is produced

Standard radiation doseradiation

Standard dose of radiation applied to remaining radiation therapy when favorable PET-CT signature is not produced

18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT)other

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.