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

Summary

The purpose of this study is to determine if RRx-001, which is added on to the cisplatin and radiation treatment, reduces the incidence of severe oral mucositis in patients with head and neck cancers. All patients in this study will receive 7 weeks of standard of care radiation therapy given with the chemotherapy agent, cisplatin. Patients will receive RRx-001 or placebo before start of standard of care treatment.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  RRx-001

  RRx-001 for injection (4 mg or 8 mg)

• Radiation
  Intensity Modulated Radiation Therapy (IMRT)

  Intensity Modulated Radiation Therapy of up to 72 Gy

• Drug
  Cisplatin for injection 100 mg/m2

  Cisplatin for injection 100 mg/m2

Locations (14)