Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx
NCT ID: NCT04667585
Last Updated: 2025-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2021-04-12
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Interim PET-CT with dose de-escalation
Participants will receive an interim PET-CT approximately 2 weeks into radiation therapy.
De-escalated radiation dose
Reduced dose of radiation applied to remaining radiation therapy when favorable interim PET-CT signature is produced
18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (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.
Interim PET-CT with standard radiation
Standard radiation dose
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)
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.
Interventions
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De-escalated radiation dose
Reduced dose of radiation applied to remaining radiation therapy when favorable interim PET-CT signature is produced
Standard radiation dose
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)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Jared Robbins, MD
Role: PRINCIPAL_INVESTIGATOR
DUHS
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Duke Raleigh Hospital
Raleigh, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Pro00105899
Identifier Type: -
Identifier Source: org_study_id
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