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

NCT04667585 | Recruiting FDA Device

• 1 other identifier: Pro00105899
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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. This study will prospectively evaluate the clinical outcomes for patients undergoing dose de-escalation.

Conditions

Oropharynx Cancer

Keywords

PET-CT

Outcome Measures

Primary Outcomes (1)

• 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

  from initiation of radiation therapy through study completion, an average of 2 years

Secondary Outcomes (6)

• locoregional progression-free survival

  from initiation of radiation therapy through study completion, an average of 2 years

• distant disease-free survival

  from initiation of radiation therapy through study completion, an average of 2 years

• overall survival

  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

  2 years

• Acute adverse events

  7 weeks

Study Arms (2)

Interim PET-CT with dose de-escalation

EXPERIMENTAL

Participants will receive an interim PET-CT approximately 2 weeks into radiation therapy.

Radiation: De-escalated radiation dose; Other: 18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT)

Interim PET-CT with standard radiation

ACTIVE COMPARATOR

Radiation: Standard radiation dose; Other: 18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT)

Interventions

De-escalated radiation dose RADIATION

Reduced dose of radiation applied to remaining radiation therapy when favorable interim PET-CT signature is produced

Interim PET-CT with dose de-escalation

Standard radiation dose RADIATION

Standard dose of radiation applied to remaining radiation therapy when favorable PET-CT signature is not produced

Interim PET-CT with standard radiation

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.

Also known as: 18 FDG-PET/CT

Interim PET-CT with dose de-escalation; Interim PET-CT with standard radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

Duke Raleigh Hospital

Raleigh, North Carolina, 27609, United States

RECRUITING

MeSH Terms

Conditions

Oropharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Jared Robbins, MD

  DUHS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Franklin, BSN, RN, OCN

CONTACT

(919) 668-3726; heather.mccullough@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants undergo either reduced radiation dose or standard radiation dose based on the metabolic signature from an Interim 18FDG-PET/CT

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 14, 2020
• Study Start: April 12, 2021
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)