Reduced Elective Nodal and CTV Dose for HPV+ Oropharyngeal Squamous Cell Carcinoma (REDUCE-30)
Sara Medek
Summary
This is a single-arm, phase II study that is designed to investigate nodal and primary tumor CTV dose de-escalation (30 Gy) in HPV positive oropharyngeal cancer.
Description
The purpose of this research is to determine if a decrease in the dose of radiation to regions which have no visible cancer will be as effective as the standard dose. The dose to all visible cancer remains unchanged to the standard radiation approach. The researchers believe that a lower dose could be just as helpful for treatment, while reducing the side effects of radiation and improving quality of life. The current standard care treatment for OPSCC can have debilitating side effects. Using a decreased dose of 30 Gy from 46-54 Gy to regions without visible cancer but which have a risk of mi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients must have histologically or cytologically confirmed history of squamous cell carcinoma of the oropharynx (OPSCC) planned for definitive chemoradiation. 2. Squamous cell carcinoma of the oropharynx (OPSCC) must be confirmed to be p16 positive based on immunohistochemical staining. 3. OPSCC must be clinical stage T1-4N1-3M0 or T3-T4N0M0 as per AJCC volume 8. 4. Patients must have measurable disease based on PET/CT imaging completed within 45 days +/- 1 week from date of eligibility confirmation. 5. Age ≥18 years. 6. ECOG performance status ≤2. 7. Patients must be…
Interventions
- DrugCisplatin
Subjects will continue to receive standard systemic therapy of cisplatin during radiation therapy. Weekly SOC Cisplatin at a dose of 40mg/m2 or every 3-week dosing of 100mg/m2 will be administered per institutional guidelines during radiation therapy. The first cisplatin infusion should be initiated during the window from 24 hours before, to 48 hours after the first scheduled radiation treatment. Skipped cisplatin infusions should not be made up, and the last cisplatin infusion should be no later than 7 days after the last fraction of radiation.
- RadiationRadiotherapy
Radiotherapy will involve a sequential boost approach. Treatment will begin with coverage of the primary site and elective nodal regions to 30 Gy, after which treatment volumes will be reduced to primary site and involved nodes only with PTV margin to 70 Gy.
Location
- University of Cincinnati Medical CenterCincinnati, Ohio