Risk Adapted De-Intensification of Radio-Chemotherapy for Oropharyngeal Squamous Cell Carcinoma

Exclusion Criteria

• •1. Prior radiotherapy for oropharyngeal squamous cell carcinoma (OPSCC) OR to the head and neck that, if combined with the protocol therapy, is deemed likely to compromise critical organs at risk in the opinion of the investigator.
• •2. Prior cancer within the last 10 years.
• ••This exclusion does not apply to the history or presence of any non-oropharynx cancer when the treating physician (or PI) deems that it is resolved or expected to have an indolent growth rate such that evaluation of the efficacy of the study treatment is unlikely to be compromised.
• •3. Prior surgery with curative intent for this OPSCC.
• •4. Patients who have undergone tonsillectomy for diagnosis or excisional biopsy of a neck node for diagnosis are eligible provided there is "gross" cancer present at the primary site or in the neck at the start of radiation therapy on this protocol with "gross" defined as visible on an imaging study.
• •5. Inhalation smoking of tobacco within the last 10 years with \> 10 pack-year equivalent history.
• •6. Currently taking Disease Modifying Rheumatoid Drugs (DMRDs) or immunosuppressive medication, for example as for organ transplant or multiple sclerosis.
• •7. Severe, active co-morbidity, defined as follows:
• •* Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
• •* Transmural myocardial infarction within the last 6 months
• •* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• •* Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
• •* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; Note, however, coagulation parameters are not required for entry into this protocol.
• •* Evidence of ACTIVE systemic lupus or scleroderma
• •* Psoriatic arthritis
• •8. Known HIV positivity. HIV positive patients are known to have worse clinical outcomes especially for local, regional, and distant cancer control. This poorer prognosis is thought to be secondary to a compromised immune system. Thus, de-intensification of radiation and chemotherapy is not justifiable in this population. HIV testing at the time of enrollment is not required.
• •9. Subjects of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 14 months after the last dose of study drug.
• •10. People who are pregnant or breastfeeding.
• •11. Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.