NCT04667585Active, not recruiting
Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx
Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx Using Metabolic Signature From Interim 18FDG-PET/CT
Source: ClinicalTrials.gov · Last updated 12 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 19 Nov 2020
- Start date
- 12 Apr 2021
- Primary completion date
- Jul 2028
- Lead sponsor
- Duke University
- Diseases
- Head and neck cancer
- NCT number
- NCT04667585
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 12 Apr 2021 to the primary completion date, Jul 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior radiotherapy to the head and neck
- Medical contraindications to radiation therapy
- Absence of gross disease on imaging prior to beginning radiation therapy
Other illness
- Distant metastatic disease
- History of active cancer other than non-melanoma skin cancer within the last 5 years
Other
- Medical contraindication to PET/CT
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Duke Raleigh Hospital Coordinator of this site? Confirm its status | Raleigh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.