Oropharynx Cancer
Conditions
Keywords
PET-CT
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.
Interventions
RADIATIONDe-escalated radiation dose
Reduced dose of radiation applied to remaining radiation therapy when favorable interim PET-CT signature is produced
RADIATIONStandard radiation dose
Standard dose of radiation applied to remaining radiation therapy when favorable PET-CT signature is not produced
OTHER18 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.
Sponsors
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Participants undergo either reduced radiation dose or standard radiation dose based on the metabolic signature from an Interim 18FDG-PET/CT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 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
| Measure | Time frame | Description |
|---|---|---|
| locoregional progression-free survival | from initiation of radiation therapy through study completion, an average of 2 years | as measured by abstraction from the medical record |
| distant disease-free survival | from initiation of radiation therapy through study completion, an average of 2 years | as measured by abstraction from the medical record |
| overall survival | from initiation of radiation therapy through study completion, an average of 2 years | as measured by abstraction from the medical record |
| progression free survival correlation in PET/CT responders versus PET/CT non-responders | 2 years | as measured by the difference in median Kaplan-Meyer values |
| Acute adverse events | 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 |
| Long term adverse events | 2 years | as measured by the number of participants who experience xerostomia, dysphagia, dysgeusia, trismus, lymphedema, superficial soft tissue fibrosis, hypothyroidism and periodontal disease |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJared Robbins, MD
DUHS
Outcome results
None listed