Status:
RECRUITING
Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx
Lead Sponsor:
Duke University
Conditions:
Oropharynx Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 identi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04667585
Start Date
April 12 2021
End Date
January 1 2028
Last Update
August 13 2025
Active Locations (2)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710
2
Duke Raleigh Hospital
Raleigh, North Carolina, United States, 27609