Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase II Trial of Selenomethionine as a Modulator of Efficacy and Toxicity of Chemoradiation in Locally-Advanced Squamous Cell Carcinoma of the Head and Neck

Inclusion Criteria:

- Biopsy-proven locally-advanced HNSCC, including those with cancers of the oral
cavity, oropharynx, hypopharynx, larynx, nasopharynx or paranasal sinuses

- Stage III, IVa or IVb disease

- No prior definitive surgery for present diagnosis

- Appropriate candidate for concurrent cisplatin and radiation as definitive treatment;
patients who receive induction chemotherapy as part of a definitive treatment program
that will include concurrent CRT are eligible for this study

- Hemoglobin >= 10 g/dL (100 g/l)

- Absolute neutrophil count >= 2,000 cells/mm^3 (2 x 10^9/l)

- Platelets >= 100,000 cells/mm^3 (100 x 10^9/l)

- Serum creatinine =< 1.5 mg/dL (133 umol/l) or calculated creatinine clearance >= 50
ml/min using the Cockcroft-Gault formula

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Able to give written informed consent

- Be willing and able to comply with study procedures

Exclusion Criteria:

- Non-regional metastatic disease (stage IVc)

- Previous malignancy within the last 5 years except for adequately treated basal or
squamous cell carcinoma of the skin or cervical intra-epithelial neoplasia

- Prior chemotherapy or radiotherapy for HNSCC, or any prior radiotherapy that would
compromise delivery of a radical dose to the HNSCC

- Known to be positive for hepatitis C or human immunodeficiency virus (HIV)

- Unable to tolerate oral medication (unless a feeding tube is in place)

- History of hypersensitivity to platinum drugs

- Symptomatic peripheral neuropathy >= National Cancer Institute (NCI)-Common
Terminology Criteria for Adverse Events (CTCAE) grade II

- Pregnant, lactating or unwilling to use adequate contraception

- Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry and
for the duration of study participation

- Planned use of amifostine for prophylaxis against radiation-induced xerostomia

- Patients taking selenium supplements in excess of 100 ug/day

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, clinically
significant cardiac arrhythmia, or psychiatric illness/social situations that would
limit compliance with study requirements

- Evidence of any other significant medical disorder or laboratory finding that in the
opinion of the Investigator compromises the subject's safety during the study