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Brief Title: Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers
Official Title: A Phase 2a Randomized, Parallel Group, Open Label, Multicenter Study to Assess the Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Locally Advanced Squamous Cell Carcinoma of the Oral Cavity or Oropharynx
Study ID: NCT03515538
Brief Summary: The purpose of this study is to determine if RRx-001, which is added on to the cisplatin and radiation treatment, reduces the duration or length 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 in arms 1, 2 and 3 will also receive RRx-001 on different schedules.
Detailed Description: The standard treatment for head and neck cancer currently includes a chemotherapy drug called cisplatin that is given by intravenous (IV) infusion and radiation, which is delivered from a machine that precisely targets the tumor. One common and unfortunate side effect of treatment with cisplatin and radiation is oral mucositis, which refers to irritation of the lining of the mouth. Oral mucositis is a serious problem 1) because the open mouth sores from oral mucositis may lead to severe pain, nutritional problems and dehydration from an inability to eat and drink, an increased risk of infection from bacteria and fungus and delay or discontinuation of treatment and 2) because there is only one approved therapy to treat or prevent it.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
John Wayne Cancer Institute @ Providence St. John's Health Center, Santa Monica, California, United States
Centura Health Research Center, Denver, Colorado, United States
George Washington University, Washington, District of Columbia, United States
Florida Hospital, Orlando, Florida, United States
Montefiore Medical Center, Bronx, New York, United States
East Carolina University, Greenville, North Carolina, United States
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
Ohio State University, Columbus, Ohio, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Ballad Health, Johnson City, Tennessee, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
UT Southwestern, Dallas, Texas, United States
Name: Bryan Oronsky, MD, PhD
Affiliation: EpicentRx, Inc.
Role: STUDY_DIRECTOR