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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

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
Heather Franklin, RN BSN OCN919 668 3726heather.mccullough@duke.edu
Duke Raleigh Hospital
Raleigh, North Carolina, 27609
Heather Franklin, BSN RN OCN(919) 668-3726heather.mccullough@duke.edu

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