Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx
Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx Using Metabolic Signature From Interim 18FDG-PET/CT
Duke University
120 participants
Apr 12, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria6
- 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
Interventions
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.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT04667585