Shortened radiation therapy after surgery for HPV-related throat cancer
A Phase II Study of Shortened Course, Dose De-Intensified Adjuvant Radiotherapy Following Transoral Robotic Surgery (TORS) and Neck Dissection for HPV-Associated Oropharyngeal Squamous Cell Carcinoma
This study is testing whether a lower dose of radiation after surgery can safely help patients with HPV-related throat cancer stay cancer-free and improve their quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 3 sites (Lancaster, Pennsylvania and 2 other locations) |
| Trial ID | NCT05714657 on ClinicalTrials.gov |
What this trial studies
This phase II study aims to evaluate the safety of a reduced radiation dose in patients with HPV-associated oropharyngeal squamous cell carcinoma who have undergone transoral robotic surgery (TORS) and neck dissection. The study will assess the effectiveness of adjuvant radiation therapy, with a focus on locoregional control rates over two years. It will also measure toxicity levels, quality of life, and survival outcomes, comparing the effects of intensity-modulated radiation therapy (IMRT) and proton therapy. Eligible patients must have specific disease characteristics and undetectable postoperative HPV DNA.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with HPV-positive oropharyngeal squamous cell carcinoma who have undergone TORS and meet specific disease criteria.
Not a fit: Patients with advanced disease (T4 or N2) or those who have received prior radiation therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to less radiation exposure for patients while maintaining effective cancer control.
How similar studies have performed: Previous studies have shown promising results with reduced radiation doses in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients ≥ 18 years old * Histologically confirmed diagnosis of squamous cell carcinoma of the oropharynx, p16-positive on immunohistochemistry or HPV-positive by In-Situ Hybridization * Pathologic T0 (unknown primary), T1, T2, or T3 disease (per AJCC 8th Ed) * Pathologic N0-N1 disease (per AJCC 8th Ed) * Preoperative plasma ctHPVDNA of ≥ 50 copies/mL * Undetectable postoperative plasma ctHPVDNA * ECOG Performance Status 0-1 Exclusion Criteria: * Prior external beam radiation therapy to the head and neck * Presence of T4 disease * ≥ 5 positive lymph nodes (which is pathologic N2 disease, per AJCC 8th edition) * Presence of distant metastatic disease * Uncontrolled inter-current illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, connective tissue disease or psychiatric illness/social situations that would limit compliance with study requirements.
Where this trial is running
Lancaster, Pennsylvania and 2 other locations
- Lancaster General Hospital — Lancaster, Pennsylvania, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Pennsylvania Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Alexander Lin, MD — University of Pennsylvania
- Study coordinator: Project Manager
- Email: RadOncCRU@PennMedicine.upenn.edu
- Phone: 215-662-3790
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.