Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04667585

Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx

Led by Duke University · Updated on 2026-02-27

120

Participants Needed

2

Research Sites

350 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologic documentation of squamous cell carcinoma of the oropharynx with p16-positive immunohistochemical staining and/or positive HPV in situ hybridization and/or positive HPV PCR
  • Stage I-III (AJCC 8th edition) with plan for concurrent chemotherapy per standard of care
  • Zubrod/ECOG performance status score of 0-1
  • Weight loss less than 10% in the 3 months before diagnosis
  • Age 18 years or older
  • No prior chemotherapy for current cancer diagnosis
Not Eligible

You will not qualify if you...

  • Prior radiotherapy to the head and neck
  • Medical contraindications to radiation therapy
  • No visible tumor disease on imaging before starting radiation therapy
  • Presence of distant metastatic disease
  • Medical contraindications to PET/CT scanning
  • History of active cancer other than non-melanoma skin cancer within the past 5 years

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Duke University Medical Center

Durham, North Carolina, United States, 27710

Actively Recruiting

2

Duke Raleigh Hospital

Raleigh, North Carolina, United States, 27609

Actively Recruiting

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Research Team

H

Heather Franklin, BSN, RN, OCN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx | DecenTrialz