Proton Image-Guided Radiation Assignment for Therapeutic Escalation Via Selection of Locally Advanced Head and Neck Cancer Patients [PIRATES]
This phase I trial studies the side effects of image-guided hyper-fractioned proton therapy in treating patients with head and neck cancer that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery (unresectable). Radiation therapy uses high energy protons to kill tumor cells and shrink tumors. The change in dose radiation frequency and dose investigated in this study may help to better control the tumor and prevent it from coming back or growing. The goal of this study is to test a new radiation schedule that administers more radiation to the tumor tissue using image guided proton therapy for patients that have a high risk of having a tumor recurrence (the tumor comes back after treatment).
• Biopsy proven diagnosis of squamous cell carcinoma of head and neck cancer originating in the oropharynx, hypopharynx, larynx, oral cavity (base of tongue) or nasopharynx. Clinical evidence should be documented, and may consist of imaging, endoscopic evaluation, palpation, and should be sufficient to estimate the image tumor characteristic of the primary tumor
• Negative for HPV by p16 immunohistochemistry (IHC) or in situ hybridization (ISH)
• Inoperable locally advances disease, i.e. stage \>= III and T stage \>= 2
• The primary radiotherapy, either in combination with chemotherapy or not, with curative intent
• No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies
• Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2
• For females of child-bearing age, a negative pregnancy test