Oropharynx CancerNCT04667585
Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx
A study testing De-escalated radiation dose, Standard radiation dose and 18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT) in people with Oropharynx Cancer, run by Duke University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharynx Cancer
- What is being tested?
- De-escalated radiation dose, Standard radiation dose and 18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Apr 2021to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27710
Duke Raleigh Hospital
Raleigh, North Carolina, 27609
About this study
Official title: Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx Using Metabolic Signature From Interim 18FDG-PET/CT
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
- Being tested
- De-escalated radiation dose, Standard radiation dose, 18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT)
- Keywords
- PET-CT
- Medical subject headings
- Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Also called 18 FDG-PET/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.
| Study group | Role | What they receive |
|---|---|---|
| Interim PET-CT with dose de-escalation | Experimental | Participants will receive an interim PET-CT approximately 2 weeks into radiation therapy. Receives: Radiation: De-escalated radiation dose; Other: 18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT) |
| Interim PET-CT with standard radiation | Active comparator | Not described Receives: Radiation: Standard radiation dose; Other: 18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
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
Measured: from initiation of radiation therapy through study completion, an average of 2 years
Secondary outcomes (6)
locoregional progression-free survival
as measured by abstraction from the medical record
Measured: from initiation of radiation therapy through study completion, an average of 2 years
distant disease-free survival
as measured by abstraction from the medical record
Measured: from initiation of radiation therapy through study completion, an average of 2 years
overall survival
as measured by abstraction from the medical record
Measured: from initiation of radiation therapy through study completion, an average of 2 years
progression free survival correlation in PET/CT responders versus PET/CT non-responders
as measured by the difference in median Kaplan-Meyer values
Measured: 2 years
Acute adverse events
as measured by the number of participants who experience dermatitis, mucositis, xerostomia, dysphagia, dysgeusia, neutropenia, thrombocytopenia, nausea, vomiting, renal toxicity, and hearing loss
Measured: 7 weeks
Long term adverse events
as measured by the number of participants who experience xerostomia, dysphagia, dysgeusia, trismus, lymphedema, superficial soft tissue fibrosis, hypothyroidism and periodontal disease
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start12 Apr 2021
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharynx CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants undergo either reduced radiation dose or standard radiation dose based on the metabolic signature from an Interim 18FDG-PET/CT
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jared Robbins, MD, Principal investigator, DUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667585
- Sponsor's protocol ID
- Pro00105899
- Status last verified
- Jun 2026
- First submitted
- 19 Nov 2020
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx Using Metabolic Signature From Interim 18FDG-PET/CT
- ClinicalTrials.gov ID
- NCT04667585
- Acronym / sponsor ID
- Pro00105899
- Conditions
- Oropharynx Cancer
- Keywords
- PET-CT
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants undergo either reduced radiation dose or standard radiation dose based on the metabolic signature from an Interim 18FDG-PET/CT
| Arm | Type | Receives |
|---|---|---|
| Interim PET-CT with dose de-escalation | Experimental | Radiation: De-escalated radiation dose, Other: 18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT)Participants will receive an interim PET-CT approximately 2 weeks into radiation therapy. |
| Interim PET-CT with standard radiation | Active comparator | Radiation: Standard radiation dose, Other: 18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| De-escalated radiation doseReduced dose of radiation applied to remaining radiation therapy when favorable interim PET-CT signature is produced | Radiation | Interim PET-CT with dose de-escalation |
| Standard radiation doseStandard dose of radiation applied to remaining radiation therapy when favorable PET-CT signature is not produced | Radiation | Interim PET-CT with standard radiation |
| 18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT)Also: 18 FDG-PET/CTThe 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. | Other | Interim PET-CT with dose de-escalation, Interim PET-CT with standard radiation |
Primary outcome
Progression-free survival
Time frame: from 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
6 secondary outcomes
locoregional progression-free survival
Time frame: from initiation of radiation therapy through study completion, an average of 2 years
distant disease-free survival
Time frame: from initiation of radiation therapy through study completion, an average of 2 years
overall survival
Time frame: from initiation of radiation therapy through study completion, an average of 2 years
progression free survival correlation in PET/CT responders versus PET/CT non-responders
Time frame: 2 years
Acute adverse events
Time frame: 7 weeks
Long term adverse events
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jared Robbins, MD principal investigator
DUHS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing De-escalated radiation dose, Standard radiation dose and 18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT) in people with Oropharynx Cancer, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: from initiation of radiation therapy through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.