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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interim PET-CT with dose de-escalation | Experimental | Participants will receive an interim PET-CT approximately 2 weeks into radiation therapy. |
|
| Interim PET-CT with standard radiation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| De-escalated radiation dose | Radiation | Reduced dose of radiation applied to remaining radiation therapy when favorable interim PET-CT signature is produced |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| locoregional progression-free survival | as measured by abstraction from the medical record | from initiation of radiation therapy through study completion, an average of 2 years |
| distant disease-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jared Robbins, MD | DUHS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States | ||
| Duke Raleigh Hospital |
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Participants undergo either reduced radiation dose or standard radiation dose based on the metabolic signature from an Interim 18FDG-PET/CT
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| Standard radiation dose | Radiation | Standard dose of radiation applied to remaining radiation therapy when favorable PET-CT signature is not produced |
|
| 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. |
|
|
as measured by abstraction from the medical record
| from initiation of radiation therapy through study completion, an average of 2 years |
| overall survival | as measured by abstraction from the medical record | 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 | 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 | 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 | 2 years |
| Raleigh |
| North Carolina |
| 27609 |
| United States |
| ID | Term |
|---|---|
| D009959 | Oropharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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