Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oropharynx Cancer | Malignant Oropharyngeal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT) | Other | — | UNRESOLVED |
| De-escalated radiation dose | Radiation | — | UNRESOLVED |
| Standard radiation dose | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interim PET-CT with dose de-escalation
- description
- Participants will receive an interim PET-CT approximately 2 weeks into radiation therapy.
- interventionNames
- Radiation: De-escalated radiation dose
- Other: 18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT)
- type
- ACTIVE_COMPARATOR
- label
- Interim PET-CT with standard radiation
- interventionNames
- Radiation: Standard radiation dose
- Other: 18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT)
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available