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

ClinicalTrials.gov ID: NCT03515538

Public ClinicalTrials.gov record NCT03515538. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT03515538
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: EpicentRx, Inc.; Industry
Enrollment: 53 participants

Conditions and interventions

Conditions

Oral Mucositis

Interventions

Drug · Radiation

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 12, 2018 (Actual)
Primary completion: Oct 22, 2019 (Actual)
Completion: Oct 8, 2020 (Actual)
Last update posted: Nov 4, 2024

2018 – 2020

United States locations

U.S. sites: 12
U.S. states: 10
U.S. cities: 12

Facility	City	State	ZIP	Site status
John Wayne Cancer Institute @ Providence St. John's Health Center	Santa Monica	California	90401	—
Centura Health Research Center	Denver	Colorado	80210	—
George Washington University	Washington D.C.	District of Columbia	20037	—
Florida Hospital	Orlando	Florida	32804	—
Montefiore Medical Center	The Bronx	New York	10467	—
East Carolina University	Greenville	North Carolina	27834	—
University of Cincinnati Medical Center	Cincinnati	Ohio	45267	—
Ohio State University	Columbus	Ohio	43210	—
Thomas Jefferson University	Philadelphia	Pennsylvania	19107	—
Ballad Health	Johnson City	Tennessee	37604	—
Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	37232	—
UT Southwestern	Dallas	Texas	75390	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03515538, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 4, 2024 · Synced Oct 22, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03515538 live on ClinicalTrials.gov.

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