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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
Reduced dose of radiation applied to remaining radiation therapy when favorable interim PET-CT signature is produced
Standard dose of radiation applied to remaining radiation therapy when favorable PET-CT signature is not produced
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.
Duke University Medical Center
Durham, North Carolina, United States
RECRUITINGDuke Raleigh Hospital
Raleigh, North Carolina, United States
RECRUITINGProgression-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
Time frame: from initiation of radiation therapy through study completion, an average of 2 years
locoregional progression-free survival
as measured by abstraction from the medical record
Time frame: from initiation of radiation therapy through study completion, an average of 2 years
distant disease-free survival
as measured by abstraction from the medical record
Time frame: from initiation of radiation therapy through study completion, an average of 2 years
overall survival
as measured by abstraction from the medical record
Time frame: 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
as measured by the difference in median Kaplan-Meyer values
Time frame: 2 years
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
Time frame: 7 weeks
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
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Time frame: 2 years