Back to resultsRadiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx
Primary Purpose
Oropharynx Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
De-escalated radiation dose
Standard radiation dose
18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT)
Sponsored by
About this trial
This is an interventional other trial for Oropharynx Cancer focused on measuring PET-CT
Eligibility 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
Sites / Locations
- Duke University Medical CenterRecruiting
- Duke Raleigh HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Interim PET-CT with dose de-escalation
Interim PET-CT with standard radiation
Arm Description
Participants will receive an interim PET-CT approximately 2 weeks into radiation therapy.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
locoregional progression-free survival
as measured by abstraction from the medical record
distant disease-free survival
as measured by abstraction from the medical record
overall survival
as measured by abstraction from the medical record
progression free survival correlation in PET/CT responders versus PET/CT non-responders
as measured by the difference in median Kaplan-Meyer values
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04667585
Brief Title
Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx
Official Title
Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx Using Metabolic Signature From Interim 18FDG-PET/CT
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
April 2027 (Anticipated)
Study Completion Date
April 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oropharynx Cancer
Keywords
PET-CT
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants undergo either reduced radiation dose or standard radiation dose based on the metabolic signature from an Interim 18FDG-PET/CT
Masking
Participant
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interim PET-CT with dose de-escalation
Arm Type
Experimental
Arm Description
Participants will receive an interim PET-CT approximately 2 weeks into radiation therapy.
Arm Title
Interim PET-CT with standard radiation
Arm Type
Active Comparator
Intervention Type
Radiation
Intervention Name(s)
De-escalated radiation dose
Intervention Description
Reduced dose of radiation applied to remaining radiation therapy when favorable interim PET-CT signature is produced
Intervention Type
Radiation
Intervention Name(s)
Standard radiation dose
Intervention Description
Standard dose of radiation applied to remaining radiation therapy when favorable PET-CT signature is not produced
Intervention Type
Other
Intervention Name(s)
18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT)
Other Intervention Name(s)
18 FDG-PET/CT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-free survival
Description
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
Time Frame
from initiation of radiation therapy through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
locoregional progression-free survival
Description
as measured by abstraction from the medical record
Time Frame
from initiation of radiation therapy through study completion, an average of 2 years
Title
distant disease-free survival
Description
as measured by abstraction from the medical record
Time Frame
from initiation of radiation therapy through study completion, an average of 2 years
Title
overall survival
Description
as measured by abstraction from the medical record
Time Frame
from initiation of radiation therapy through study completion, an average of 2 years
Title
progression free survival correlation in PET/CT responders versus PET/CT non-responders
Description
as measured by the difference in median Kaplan-Meyer values
Time Frame
2 years
Title
Acute adverse events
Description
as measured by the number of participants who experience dermatitis, mucositis, xerostomia, dysphagia, dysgeusia, neutropenia, thrombocytopenia, nausea, vomiting, renal toxicity, and hearing loss
Time Frame
7 weeks
Title
Long term adverse events
Description
as measured by the number of participants who experience xerostomia, dysphagia, dysgeusia, trismus, lymphedema, superficial soft tissue fibrosis, hypothyroidism and periodontal disease
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heather Franklin, BSN, RN, OCN
Phone
(919) 668-3726
Email
heather.mccullough@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Brizel, MD
Organizational Affiliation
DUHS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Franklin, RN BSN OCN
Phone
919-668-3726
Email
heather.mccullough@duke.edu
First Name & Middle Initial & Last Name & Degree
David Brizel, MD
First Name & Middle Initial & Last Name & Degree
Yvonne Mowery, MD PhD
Facility Name
Duke Raleigh Hospital
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Franklin, BSN RN OCN
Phone
919-668-3726
Email
heather.mccullough@duke.edu
First Name & Middle Initial & Last Name & Degree
Jessica Lee, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx
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