EValuating the Safety Of De-escaLated Head and Neck Irradiation in HPV positivE Oropharynx Cancer in Non-smokers/Minimal Smokers
A prospective, observational study evaluating the durability of local/regional control of previously published de-escalated radiotherapy protocols for patients with P16 positive oropharynx cancers who have minimal nicotine exposure who are not current uses (< 10 pack year smoking history; < 10 year history of any nicotine product [electronic cigarette, chewing tobacco]). Quality of Life measures will also be collected.
• Age > 18 years
• Histologic confirmation of tumor of the oropharynx
• Radiation therapy (de-escalated head and neck irradiation) decision has been made
• Human Papilloma Virus (HPV) associated cancer as determined by positive p16 immunohistochemistry
• HPV positivity is defined by p16 IHC staining of > 70% of tumor cells (strong and diffuse nuclear and cytoplasmic staining)
• For cases that are indeterminate or if p16 testing cannot be accurately performed, HPV positivity can be confirmed by high-risk HPV DNA Testing which covers the following HPV subtypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68
• < 10 pack year smoking history OR < 10 year nicotine use history
• No current tobacco/nicotine use (including electronic cigarettes and chewing tobacco)
• T1-T3, N0-N2 (AJCC8) requiring definitive therapy greater than surgery alone
• Ability to provide informed written consent
• Willingness to return to Sanford Cancer Center for follow-up
• Life expectancy > 12 weeks
• ECOG performance status < 3 (Appendix B)
• Adequate organ function for chemotherapy and radiotherapy