Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers

PHASE2CompletedINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

July 12, 2018

Primary Completion Date

October 22, 2019

Study Completion Date

October 8, 2020

Conditions
Oral Mucositis
Interventions
DRUG

RRx-001

RRx-001 for injection

DRUG

Cisplatin for injection

Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients

RADIATION

Radiation Therapy

Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study

Trial Locations (12)

10467

Montefiore Medical Center, The Bronx

19107

Thomas Jefferson University, Philadelphia

20037

George Washington University, Washington D.C.

27834

East Carolina University, Greenville

32804

Florida Hospital, Orlando

37232

Vanderbilt-Ingram Cancer Center, Nashville

37604

Ballad Health, Johnson City

43210

Ohio State University, Columbus

45267

University of Cincinnati Medical Center, Cincinnati

75390

UT Southwestern, Dallas

80210

Centura Health Research Center, Denver

90401

John Wayne Cancer Institute @ Providence St. John's Health Center, Santa Monica

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Prothex, Inc.

INDUSTRY

lead

EpicentRx, Inc.

INDUSTRY