HPV DNA-Guided Radiotherapy De-intensification of Head and Neck Squamous Cell Carcinoma

Exclusion Criteria17

• Evidence of distant metastatic disease
• Prior history of radiotherapy to the head and/or neck
• Had surgery for oropharyngeal cancer within 8 months of enrollment unless it was an incomplete oncologic surgery. Participant is eligible if the gross tumor was not completely removed.
• Diagnosis of T3-4 and/or N+ disease with no plans to receive concurrent chemotherapy.
• Diagnosis of a current or prior invasive malignancy (except non-melanoma skin cancer) unless the participant has been disease free for at least 3 years.
• Participant is a prisoner
• Known contraindications to head and neck radiation therapy such as ataxia telangiectasia or scleroderma.
• Pregnancy or lactation
• Active or severe co-morbidities as defined by the following:
• Unstable angina and/or congestive heart failure requiring hospitalization up to 180 days before registration
• Transmural myocardial infarction up to 180 days before registration
• 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 as determined by the treating clinician resulting in clinical jaundice and/or coagulation effects or severe liver dysfunction.
• Acquired immune deficiency syndrome (AIDS) based upon current CDC definition. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be slightly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
• Tobacco smoking history of 10 pack years or greater, or ≥ 20 pack years if smoking cessation occurred at least 1 year prior to enrollment
• Current use of antineoplastic drugs for other malignancies.