Clinical Trial Information
Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.
- Age ≥ 18 years.
- Pathologically proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell
carcinoma, carcinoma NOS) of the head/neck (oral cavity, oropharynx, hypopharynx or larynx); pathologic stage III or IVA (AJCC
8): T3-T4a, N0-3, M0 or T1-T2, N1-3, M0.
- Patient has undergone total resection of the primary tumor with curative intent.
- NOTE: Patient is to be pre-registered to screening (Step 0) and tissue submitted to Foundation Medicine as soon as possible after surgery in order to meet the 8 week deadline to register the patient to Step 1 after surgery. Full assay minimum turn-around time is 17-24 days.
- For oropharynx primary tumors, the patient must have negative HPV status of the tumor as determined by p16 protein expression using immunohistochemistry (IHC).
- Patients with, per the operative and/or pathology report, positive margin(s) [tumor present at the cut or inked edge of the tumor] which is not superceded by an additional margin of tumor-negative tissue, nodal extracapsular extension, and/or gross residual disease after surgery are not eligible.
- Patients with a history of a curatively treated malignancy must be disease-free for at least two years except for carcinoma in situ of
cervix and/or non-melanomatous skin cancer. Patients must not have received chemotherapy or investigational therapy within two years of surgical resection of the primary tumor.
- Patient must not have had previous irradiation to the head and neck that would result in overlap in radiation fields for the current disease.
- Patients with recurrent disease or multiple primaries are ineligible.