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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT04667585
Status
Recruiting
Apply to this trial

Conditions

  • Oropharynx Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • De-escalated radiation dose — RADIATION
    Reduced dose of radiation applied to remaining radiation therapy when favorable interim PET-CT signature is produced
  • Standard radiation dose — RADIATION
    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.

Study Details

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.

Key Dates

Start date
Apr 12, 2021
Status verified
Feb 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Interim PET-CT with dose de-escalation
    Participants will receive an interim PET-CT approximately 2 weeks into radiation therapy.
  • Active Comparator: Interim PET-CT with standard radiation

Primary Outcome Measure

Progression-free survival [ Time Frame: from initiation of radiation therapy through study completion, an average of 2 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710
Heather Franklin, RN BSN OCN
[email protected]
919 668 3726
Jared Robbins, MD (PRINCIPAL_INVESTIGATOR)
Duke Raleigh HospitalRaleighNorth Carolina27609
Heather Franklin, BSN RN OCN
[email protected]
(919) 668-3726
Jared Robbins, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Duke University Medical Center· Durham, NCDuke Raleigh Hospital· Raleigh, NC

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