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Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx
RECRUITINGN/ASponsored by Duke University
Actively Recruiting
PhaseN/A
SponsorDuke University
Started2021-04-12
Est. completion2028-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT04667585
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
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria: * 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 Criteria: * 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
Conditions2
CancerOropharynx Cancer
Locations2 sites
Duke University Medical Center
Durham, North Carolina, 27710
Duke Raleigh Hospital
Raleigh, North Carolina, 27609
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Actively Recruiting
PhaseN/A
SponsorDuke University
Started2021-04-12
Est. completion2028-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT04667585