Reducing radiation doses for HPV-related throat cancer
Radiotherapy Dose De-escalation in HPV-Associated Cancers of the Oropharynx Using Metabolic Signature From Interim 18FDG-PET/CT
NA · Duke University · NCT04667585
This study is testing if using special imaging during radiation therapy can help find patients with HPV-related throat cancer who can safely receive lower radiation doses to reduce side effects while still getting effective treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Durham, North Carolina and 1 other locations) |
| Trial ID | NCT04667585 on ClinicalTrials.gov |
What this trial studies
This study aims to utilize intra-treatment 18FDG-PET/CT imaging during radiation therapy for HPV-associated oropharyngeal cancer to identify patients who may benefit from reduced radiation doses. By evaluating the clinical outcomes of patients receiving dose de-escalation, the study seeks to optimize treatment while minimizing side effects. The approach focuses on patients with favorable responses to treatment, allowing for a more personalized therapy plan. This prospective evaluation will help determine the safety and efficacy of lower radiation doses in this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with HPV-positive oropharyngeal squamous cell carcinoma who are eligible for concurrent chemotherapy.
Not a fit: Patients with prior head and neck radiation therapy or those with distant metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer treatment options with fewer side effects for patients with HPV-related oropharyngeal cancer.
How similar studies have performed: Other studies have shown promise in dose de-escalation strategies for HPV-related cancers, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Durham, North Carolina and 1 other locations
- Duke University Medical Center — Durham, North Carolina, United States (RECRUITING)
- Duke Raleigh Hospital — Raleigh, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Jared Robbins, MD — DUHS
- Study coordinator: Heather Franklin, BSN, RN, OCN
- Email: heather.mccullough@duke.edu
- Phone: (919) 668-3726
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Oropharynx Cancer, PET-CT