Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx Using Metabolic Signature From Interim 18FDG-PET/CT
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 4
- Primary Endpoint
- Progression-free survival
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Interim PET-CT with dose de-escalation
Participants will receive an interim PET-CT approximately 2 weeks into radiation therapy.
Intervention: De-escalated radiation dose (Radiation)
Interim PET-CT with dose de-escalation
Participants will receive an interim PET-CT approximately 2 weeks into radiation therapy.
Intervention: 18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT) (Other)
Interim PET-CT with standard radiation
Intervention: Standard radiation dose (Radiation)
Interim PET-CT with standard radiation
Intervention: 18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT) (Other)
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: from initiation of radiation therapy through study completion, an average of 2 years
defined as the time between initiation of radiation treatment and the first documented recurrence of disease or death due to any cause as measured by medical record abstraction
Secondary Outcomes
- locoregional progression-free survival(from initiation of radiation therapy through study completion, an average of 2 years)
- overall survival(from initiation of radiation therapy through study completion, an average of 2 years)
- Long term adverse events(2 years)
- progression free survival correlation in PET/CT responders versus PET/CT non-responders(2 years)
- distant disease-free survival(from initiation of radiation therapy through study completion, an average of 2 years)
- Acute adverse events(7 weeks)