Daily Adaptive Radiotherapy Compared to Conventional Margin Radiotherapy for the Reduction of Dry Mouth in Patients Undergoing Treatment for Stage I-IVB Head and Neck Cancers

Inclusion Criteria

• Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx, larynx, or hypopharynx. Squamous cell carcinoma of unknown primary is not allowed
• Patients must have clinically or radiographically evident measurable disease at the primary site and/or nodal stations. Diagnostic lymph node excision (< 2 nodes) is also allowable
• Patients may undergo a diagnostic or therapeutic transoral resection for a T1-2 tonsil or base of tongue cancer
• Clinical stage I-IVB (American Joint Committee on Cancer [AJCC], 7th edition); stages I-II glottic cancer are excluded
• Age >= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• All men, as well as women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * A female of child-bearing potential is any woman (regardless of sexual orientation, marital status, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: ** Has not undergone a hysterectomy or bilateral oophorectomy; or ** Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
• Negative serum or urine pregnancy test within 2 weeks before registration for women of childbearing potential
• Neck computed tomography (CT) and/or neck magnetic resonance imaging (MRI), and positron emission tomography (PET)-CT (at least skull-to-thigh)
• Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

• Distant metastasis
• Inability to undergo PET-CT
• Stage I and II glottic carcinoma
• Gross total excision of both the primary and nodal disease
• Synchronous non-skin cancer primaries outside of the oropharynx, larynx, and hypopharynx except for low- and intermediate-risk prostate cancer and synchronous well-differentiated thyroid cancer; in the latter case, surgery may occur before or after treatment, provided all other eligibility criteria are met
• Prior invasive malignancy with an expected disease-free interval of less than 3 years
• Prior systemic chemotherapy for the study cancer; prior chemotherapy for a remote cancer is allowable
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields
• Subjects may not be receiving any other investigational agents
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to the chemotherapy agents in this study (if necessary)
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements
• Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
• History of severe immunosuppression, including human immunodeficiency virus (HIV), and organ or autologous or allogeneic stem cell transplant