Actively Recruiting
Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx
Led by Duke University · Updated on 2026-02-27
120
Participants Needed
2
Research Sites
350 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologic documentation of squamous cell carcinoma of the oropharynx with p16-positive immunohistochemical staining and/or positive HPV in situ hybridization and/or positive HPV PCR
- Stage I-III (AJCC 8th edition) with plan for concurrent chemotherapy per standard of care
- Zubrod/ECOG performance status score of 0-1
- Weight loss less than 10% in the 3 months before diagnosis
- Age 18 years or older
- No prior chemotherapy for current cancer diagnosis
You will not qualify if you...
- Prior radiotherapy to the head and neck
- Medical contraindications to radiation therapy
- No visible tumor disease on imaging before starting radiation therapy
- Presence of distant metastatic disease
- Medical contraindications to PET/CT scanning
- History of active cancer other than non-melanoma skin cancer within the past 5 years
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
2
Duke Raleigh Hospital
Raleigh, North Carolina, United States, 27609
Actively Recruiting
Research Team
H
Heather Franklin, BSN, RN, OCN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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