EValuating the Safety Of De-escaLated Head and Neck Irradiation in HPV positivE Oropharynx Cancer in Non-smokers/Minimal Smokers

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a prospective, single-site, observational study in head and neck cancer participants. The purpose of this study is to provide a systematic platform to analyze, interpret, and track radiation dose de-escalation therapy and associated participant outcomes from treatments identified by these results. Participants will be asked to complete quality of life questionnaires at regular time points before, during, and after treatment.

Official Title
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EValuating the Safety Of De-escaLated Head and Neck Irradiation in HPV positivE Oropharynx Cancer in Non-smokers/Minimal Smokers

Conditions
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Oropharyngeal Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Any of the following because the inclusion criteria require delivery of radiotherapy and chemotherapy which is known to be genotoxic, and is associated with mutagenic and teratogenic effects: pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception. Prior head and neck radiotherapy Any factor precluding safe delivery of chemotherapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The durability of local disease control of de-escalated radiotherapy protocols in the community cancer center setting. | Number of participants who remain disease free from the end of treatment to 5 years after treatment. | End of treatment to 5 years after end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oropharynx, head and neck cancer