Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04667585
Recruitment Status : Recruiting
First Posted : December 14, 2020
Last Update Posted : November 16, 2021
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Oropharynx Cancer Radiation: De-escalated radiation dose Radiation: Standard radiation dose Other: 18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant)
Primary Purpose: Other
Official Title: Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx Using Metabolic Signature From Interim 18FDG-PET/CT
Actual Study Start Date : April 9, 2021
Estimated Primary Completion Date : April 2027
Estimated Study Completion Date : April 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Interim PET-CT with dose de-escalation
Participants will receive an interim PET-CT approximately 2 weeks into radiation therapy.
Radiation: De-escalated radiation dose
Reduced dose of radiation applied to remaining radiation therapy when favorable interim PET-CT signature is produced

Other: 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 Name: 18 FDG-PET/CT

Active Comparator: Interim PET-CT with standard radiation Radiation: Standard radiation dose
Standard dose of radiation applied to remaining radiation therapy when favorable PET-CT signature is not produced

Other: 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 Name: 18 FDG-PET/CT




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. locoregional progression-free survival [ Time Frame: from initiation of radiation therapy through study completion, an average of 2 years ]
    as measured by abstraction from the medical record

  2. distant disease-free survival [ Time Frame: from initiation of radiation therapy through study completion, an average of 2 years ]
    as measured by abstraction from the medical record

  3. overall survival [ Time Frame: from initiation of radiation therapy through study completion, an average of 2 years ]
    as measured by abstraction from the medical record

  4. progression free survival correlation in PET/CT responders versus PET/CT non-responders [ Time Frame: 2 years ]
    as measured by the difference in median Kaplan-Meyer values

  5. Acute adverse events [ Time Frame: 7 weeks ]
    as measured by the number of participants who experience dermatitis, mucositis, xerostomia, dysphagia, dysgeusia, neutropenia, thrombocytopenia, nausea, vomiting, renal toxicity, and hearing loss

  6. Long term adverse events [ Time Frame: 2 years ]
    as measured by the number of participants who experience xerostomia, dysphagia, dysgeusia, trismus, lymphedema, superficial soft tissue fibrosis, hypothyroidism and periodontal disease



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04667585


Contacts
Layout table for location contacts
Contact: Heather Franklin, BSN, RN, OCN (919) 668-3726 heather.mccullough@duke.edu

Locations
Layout table for location information
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Heather Franklin, RN BSN OCN    919-668-3726    heather.mccullough@duke.edu   
Principal Investigator: David Brizel, MD         
Principal Investigator: Yvonne Mowery, MD PhD         
Duke Raleigh Hospital Recruiting
Raleigh, North Carolina, United States, 27609
Contact: Heather Franklin, BSN RN OCN    919-668-3726    heather.mccullough@duke.edu   
Sub-Investigator: Jessica Lee, MD         
Sponsors and Collaborators
Duke University
Investigators
Layout table for investigator information
Principal Investigator: David Brizel, MD DUHS
Principal Investigator: Yvonne Mowery, MD PhD DUHS
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04667585    
Other Study ID Numbers: Pro00105899
First Posted: December 14, 2020    Key Record Dates
Last Update Posted: November 16, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Duke University:
PET-CT
Additional relevant MeSH terms:
Layout table for MeSH terms
Oropharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action