This phase II trial investigates the use of 18FDG-positron emission tomography/computed tomography (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 (chemotherapy + radiation therapy) dose de-escalation. It is not known if patients who show a response on 18FDG PET/CT imaging and receive lower doses of radiation may have similar disease outcomes with fewer side effects when compared to those receiving the standard dose of radiation therapy. The purpose of this study is to evaluate treatment response in patients who receive a lower dose of chemoradiation after an early treatment response is identified on 18FDG PET-CT imaging.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04667585.
Locations matching your search criteria
United States
North Carolina
Durham
Duke University Medical CenterStatus: Active
Contact: David Manfield Brizel
Phone: 919-668-5637
PRIMARY OBJECTIVE:
I. To determine 2-year progression-free survival in patients with HPV-associated oropharyngeal cancer treated with definitive chemoradiation with dose de-escalation based on tumor standardized uptake value maximum (SUVmax) on intra-treatment fludeoxyglucose F-18 (18FDG)-PET/CT performed after 20 Gy.
SECONDARY OBJECTIVES:
I. To evaluate locoregional progression-free survival, distant disease-free survival, and overall survival in patients using the above approach.
II. To validate the association between intra-treatment tumor SUVmax and progression-free survival.
III. To assess the toxicity profile (both acute and long-term) of dose de-escalated radiation therapy and chemotherapy.
OUTLINE:
Patients receive standard of care treatment consisting of radiation therapy daily, five days per week, and cisplatin intravenously (IV) once weekly (QW) for 2 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive 18FDG IV and undergo PET/CT. Patients are then assigned to 1 of 2 groups based on results of PET/CT.
DE-ESCALATED RADIATION DOSE: Patients with a favorable response after PET/CT receive radiation therapy and cisplatin for an additional 4 weeks in the absence of disease progression or unacceptable toxicity.
STANDARD RADIATION DOSE: Patients determined to have an inadequate response after PET/CT receive radiation therapy and cisplatin for an additional 5 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1, 3, 6, 12 and 24 months.
Lead OrganizationDuke University Medical Center
Principal InvestigatorDavid Manfield Brizel
