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Radiotherapy Dose De-escalation for HPV-Associated Oropharynx Cancer

This study is for people with HPV-related oropharynx cancer (cancer of the middle part of the throat, linked to human papillomavirus). It aims to see if a reduced dose of radiation, called de-escalated radiation dose, can be used for some patients. You might receive this reduced dose if a special type of CT scan, called an 18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT) scan, shows a good response to initial treatment. Otherwise, you would receive the standard radiation dose. The study will look at how long people live without their cancer progressing (progression-free survival) over about 2 years. To join, you must have HPV-positive oropharynx cancer, be between 18 and an unspecified upper age, and meet other health criteria. The study is currently unclear about its recruitment status and plans to enroll 120 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 120 participants, but the phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the start of radiation therapy through the study's completion, which is an average of 2 years, to measure progression-free survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04667585

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

Active, Not Recruiting
NAAges 18+InterventionalTreatment
Duke University
~120 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:De-escalated radiation doseStandard radiation dose18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT)

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival
Measured over from initiation of radiation therapy through study completion, an average of 2 years

Conditions

Oropharynx Cancer

Explore related trials

Oropharyngeal CarcinomaHPV

NCT04667585

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Duke Raleigh Hospital

    Raleigh, North Carolinano site contact published

  • Duke University Medical Center

    Durham, North Carolinano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jared Robbins, MD · PRINCIPAL_INVESTIGATOR · DUHS

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Histologic documentation of squamous cell carcinoma of the oropharynx with p16-positive immunohistochemical staining and/or positive HPV in situ hybridization (ISH) and/or positive HPV PCR
Stage I-III (AJCC 8th edition) with plan for concurrent chemotherapy per standard of care treatment
Zubrod/ECOG score of 0-1
Weight loss \<10% in the 3 months prior to diagnosis
≥ 18 years of age
No prior chemotherapy for their current cancer diagnosis

Exclusion

Prior radiotherapy to the head and neck
Medical contraindications to radiation therapy
Absence of gross disease on imaging prior to beginning radiation therapy
Distant metastatic disease
Medical contraindication to PET/CT
History of active cancer other than non-melanoma skin cancer within the last 5 years

What this trial measures

  • Progression-free survivalfrom initiation of radiation therapy through study completion, an average of 2 years

    defined as the time between initiation of radiation treatment and the first documented recurrence of disease or death due to any cause as measured by medical record abstraction