A Study of Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer Receiving Postoperative Radiotherapy and Concurrent Chemotherapy

Inclusion Criteria

• •History of newly diagnosed histologically confirmed squamous cell carcinoma (American Joint Committee on Cancer \[AJCC\] Stage II, III, IVA, or IVB) involving either the oral cavity, oropharynx, nasopharynx, hypopharynx, or larynx, post surgical resection (R0, R1)
• •Scheduled to receive adjuvant concurrent chemoradiation treatment within 12 weeks of surgery
• •High-risk subject defined by presence of at least one of the following: R1 resection margins; T3 or T4 tumor stage; 3 or more positive lymph node metastases; \<3 lymph node metastases with extracapsular extension of the disease
• •Radiation treatment field to receive planned dose of at least 50Gy to areas of the oral cavity/oropharynx mucosa that can be visualized