Adaptive Radiotherapy Boost for the Treatment of Patients with Head and Neck Squamous Cell Cancer

Inclusion Criteria

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 18 or older
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1
• Patients with histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, or unknown primary in the neck
• Patients with measurable disease, either at primary site or neck per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• For patients planned to receive chemotherapy: * Adequate hematologic function within 28 days defined as follows: ** Absolute neutrophil count (ANC) >= 1500/mm^3; ** Platelet count >= 150,000/mm^3; and ** Hemoglobin >= 8 g/dL * Adequate hepatic function within 45 days before randomization defined as follows: ** Total bilirubin must be =< 1.5 x ULN (upper limit of normal) for the lab unless the patient has Gilbert's disease or similar syndrome involving slow conjugation of bilirubin then must be =< 3 x ULN; and ** Alkaline phosphatase must be =< 3 x ULN for the lab; and ** Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be =< 3 x ULN for the lab * Adequate renal function within 28 days before randomization defined as serum creatinine =< ULN for the lab and measured or calculated creatinine clearance > 60 mL/min * International normalized ratio of prothrombin time (INR) and prothrombin time (PT) within 28 days before randomization must be within normal limits (WNL) for the lab. Patients who are therapeutically treated with an agent such as warfarin may participate if they are on a stable dose and no underlying abnormality in coagulation parameters exists per medical history
• Negative serum pregnancy test within before starting study treatment in woman with childbearing potential

Exclusion Criteria

• Pregnancy or lactation
• Patients who have had prior radiotherapy to the head and neck or prior systemic therapy for the index cancer
• Patients who had undergone definitive surgery for the index cancer
• Patients with distant metastatic disease
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements