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A Randomized Placebo-Controlled Trial of Two Schedules of RRx-001 for the Attenuation of Severe Oral Mucositis in Patients Receiving Concomitant Chemoradiation for the Treatment of Locally Advanced Squamous Cell Carcinoma of the Oral Cavity or Oropharynx (KEVLARx)

Efficacy -To evaluate the efficacy of two dosing regimens of RRx-001 as comparted to placebo in terms of the attenuation of severe oral mucositis (SOM, WHO Grade greater than or equal to 3) in patients receiver CRT for the treatment of cancers of the oral cavity or oropharynx through IMRT -To evaluate the efficacy of two dosing regimens of RRx-001 as comparted to placebo in terms of the attenuation of severe oral mucositis (SOM, WHO Grade greater than or equal to 3) in patients receiver CRT for the treatment of cancers of the oral cavity or oropharynx through I60 Gy. Safety: -To assess the safety and tolerability of 2 dosing schedules of RRx-001 during CRT treatment and for 6-8 weeks following the end of IMRT -To assess the long-term effect of RRx-001 on tumor response compared to placebo

Efficacy -To evaluate the efficacy of two dosing regimens of RRx-001 as comparted to placebo in terms of the attenuation of severe oral mucositis (SOM, WHO Grade greater than or equal to 3) in patients receiver CRT for the treatment of cancers of the oral cavity or oropharynx through IMRT -To evaluate the efficacy of two dosing regimens of RRx-001 as comparted to placebo in terms of the attenuation of severe oral mucositis (SOM, WHO Grade greater than or equal to 3) in patients receiver CRT for the treatment of cancers of the oral cavity or oropharynx through I60 Gy. Safety: -To assess the safety and tolerability of 2 dosing schedules of RRx-001 during CRT treatment and for 6-8 weeks following the end of IMRT -To assess the long-term effect of RRx-001 on tumor response compared to placebo