ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients

Inclusion Criteria: * squamous cell carcinoma of the head and neck * treatment plan to receive IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose of 60-72 Gy * Treatment plan to receive standard cisplatin monotherapy * Age 18 years or older * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Adequate hematologic, renal and liver function * Negative serum pregnancy test * Use of effective contraception Exclusion Criteria: * Tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, or salivary glands * Metastatic disease * Prior radiotherapy to the region of the study cancer or adjacent anatomical * Prior induction chemotherapy * Receiving any approved or investigational anti-cancer agent other than those provided for in this study * Concurrent participation in another interventional clinical study * Inability to eat soft solid food at baseline * Malignant tumors other than HNC within the last 5 years * Active infectious disease excluding oral candidiasis * Presence of oral mucositis at baseline * Known history of HIV or active hepatitis B/C * Female patients who are pregnant or breastfeeding * Known allergies or intolerance to cisplatin and similar platinum-containing compounds * Requirement for concurrent treatment with nitrates or other drugs that may create a risk for a precipitous decrease in blood pressure