Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers (PREVLAR)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03515538 |
Recruitment Status :
Completed
First Posted : May 3, 2018
Last Update Posted : January 11, 2021
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Condition or disease | Intervention/treatment | Phase |
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Oral Mucositis | Drug: RRx-001 Drug: Cisplatin for injection Radiation: Radiation Therapy | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 48 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
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 |
Actual Study Start Date : | July 12, 2018 |
Actual Primary Completion Date : | October 22, 2019 |
Actual Study Completion Date : | October 8, 2020 |

Arm | Intervention/treatment |
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Experimental: RRx-001 Pre-Treatment plus SOC
Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC (four doses total). No additional RRx-001 will be given during the course of RT/cisplatin
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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 |
Experimental: RRx-001 Pre-Treatment, 2 Concurrent Doses plus SOC
Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC. In addition, one dose of RRx-001 will be given on the last radiation day in each of weeks 2 and 5 during RT/cisplatin administration
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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 |
Experimental: RRx-001 Pre-Treatment, 6 Concurrent Doses plus SOC
Two infusions of RRx-001 will be given each week during the two weeks prior to the start of RT/cisplatin SOC. In addition, one dose of RRx-001 will be given on the last radiation day of each of the first 6 weeks during RT/cisplatin administration
|
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 |
Active Comparator: Standard of Care
No doses of RRx-001 will be administered. Patients assigned to this arm will receive only standard of care in the form of a 7-week course of fractionated radiation therapy concurrent with a high-dose cisplatin regimen (100 mg/m2 dose in each of RT weeks 1, 4, and 7).
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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 |
- Duration of Severe Oral Mucositis (SOM) [ Time Frame: up to one year ]Duration in days of severe oral mucositis (SOM). Defined as oral mucositis grade 3 or 4 on the WHO Mucositis Grading Scale which comprises 5 grades: 0 = none, 1=oral soreness, erythema, 2=oral erythema, ulcers, solid diet tolerated, 3=oral ulcers, liquid diet only, and 5=oral alimentation impossible. Sever Oral Mucositis duration is obtained by totaling the number of days a given patient experiences oral mucositis grade 3 or 4 during the randomized treatment period. Higher Sever Oral Mucositis duration numbers are indicative of worst outcomes. The total Sever Oral Mucositis duration for a given patient will range between 0 days and the maximum number of days the patient participated in the randomized treatment period.
- Time to onset of Sever Oral Mucositis [ Time Frame: up to one year ]Time to onset of Sever Oral Mucositis defined as time (in days) from randomization to the first observed Sever Oral Mucositis. Longer Sever Oral Mucositis onset times are indicative of a better outcome. The time to onset of Sever Oral Mucositis for a given patient will range between 0 days and the maximum number of days the patient participated in the randomized treatment period.
- Incidence of Sever Oral Mucositis [ Time Frame: up to one year ]Incidence of Sever Oral Mucositis defined as the proportion of patients experiencing Sever Oral Mucositis during the randomized treatment period. Sever Oral Mucositis incidence range is 0 to 100%, and higher percentages are indicative of worse outcomes.
- Duration of ulcerative Oral Mucositis [ Time Frame: up to one year ]Duration (in days) of ulcerative oral mucositis defined as the proportion of patients experiencing oral mucositis during the randomized treatment period. Defined as oral mucositis grade 0 or 1 on the WHO Mucositis Grading Scale (described above). Longer duration of ulcerative oral mucositis is indicative of a worse outcome. The total ulcerative oral mucositis duration for a given patient will range between 0 days and the maximum number of days the patient participated in the randomized treatment period.
- Incidence of ulcerative Oral Mucositis [ Time Frame: up to one year ]Incidence of ulcerative oral mucositis defined as the proportion of patients experiencing ulcerative oral mucositis during the randomized treatment period. Ulcerative oral mucositis is defined as oral mucositis grade 0 or 1 on the WHO Mucositis Grading Scale (described above) and ranges from 0 to 100% with higher percentages being indicative of worse outcomes.
- Patient-reported pain [ Time Frame: up to one year ]Patient-reported mouth and throat soreness score obtained from Question #2 from the Oral Mucositis Daily Questionnaire (OMDQ) filled out by the patient. OMDQ Question #2 asked "During the last 24 hours, how much mouth and throat soreness did you have?". OMDQ Question # 2 uses the following five-point categorical scale to quantity mouth and throat soreness: 0=no soreness, 1=a little soreness, 2=moderate soreness, 3=quite a lot of soreness and 4=extreme soreness. Higher mouth and throat soreness values are indicative of worse outcomes. The range of the month and throat values is 0, 1, 2, 3, 4.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Pathologically confirmed diagnosis of squamous cell carcinoma (SCC) of the oral cavity and oropharynx Note: Patients with unknown primary tumors whose treatment plan matches the requirements specified in Inclusion Criterion #3 below are eligible for the trial
- Treatment planned to include standard cisplatin monotherapy administered either every three weeks (100 mg/m2 for 3 doses) with concomitant radiation delivered as a continuous course of IMRT with single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose between 60 Gy and 72 Gy. Planned radiation treatment fields must include at least two oral sites (buccal mucosa, floor of mouth, tongue, soft palate) that are each planned to receive a total of > 55 Gy. Patients who have had prior surgery are eligible, provided they have fully recovered from surgery, and patients who may have surgery in the future are eligible.
- ECOG performance status ≤ 2.
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Participants must have adequate organ and marrow function as defined below:
A. Absolute neutrophil count (ANC) >1,500 / mm3 B. Platelets > 100,000 / mm3 C. Hemoglobin ≥ 9.0 g/dL
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Adequate renal and liver function as indicated by:
A. Serum creatinine acceptable for treatment with cisplatin per institutional guidelines) B. Total bilirubin ≤ 1.5 x upper-normal limit (ULN) C. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN D. Alkaline phosphatase ≤ 2.5 x ULN
- Human papilloma virus (HPV) status in tumor has been documented using tumor immunohistochemistry for HPV-p16 or other accepted test for patients with cancers of the oropharynx, base of tongue, or unknown primary.
- Age 18 years or older
- Patient must consent to the access, review and analysis of previous medical and cancer history, including imaging data by the sponsor or a third party nominated by the sponsor.
- Ability to understand and sign a written informed consent document.
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Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.
Note: A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been postmenopausal for at least 12 consecutive months
- Adequate visual access to permit examination of the following oral cavity sites: lips, buccal mucosa, floor of mouth, ventral and lateral tongue and soft palate.
Exclusion Criteria:
- Prior radiation to the head and neck
- Tumor of the lips, nasopharynx, hypopharynx, larynx, or salivary glands
- Patients with simultaneous primaries or bilateral tumors
- Metastatic disease (M1) Stage IV
- Malignant tumors other than HNC within the last 5 years, unless treated definitively and with low risk of recurrence in the judgment of the treating investigator
- Presence of oral mucositis (WHO Score ≥ Grade 1) or other oral mucosal ulceration at study entry
- Grade 3 or 4 dysphagia or odynophagia (National Cancer Institute Common Toxicity Criteria, version 5.0) or inability to eat a normal diet
- Requirement at baseline for parenteral or gastrointestinal tube-delivered nutrition for any reason
- Known history of HIV or active hepatitis B/C (patients who have been vaccinated for hepatitis B and do not have a history of infection are eligible)
- Any significant medical diseases or conditions, as assessed by the investigators and sponsor that would substantially increase the medical risks of participating in this study (i.e., uncontrolled diabetes, NYHA II-IV congestive heart failure, myocardial infarction within 6 months of study, severe chronic pulmonary disease or active uncontrolled infection, uncontrolled or clinically relevant pulmonary edema).
- Pregnant or nursing
- Untreated active oral or dental infection, including severe tooth decay (caries)
- Known allergies or intolerance to cisplatin and similar platinum-containing compounds
- Evidence of immediate life-threatening disease or a life expectancy of less than 3 months
- Receipt of unapproved or off-label medication within 30 days prior to start of study treatment
- Sjogren syndrome

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515538
United States, California | |
John Wayne Cancer Institute @ Providence St. John's Health Center | |
Santa Monica, California, United States, 90401 | |
United States, Colorado | |
Centura Health Research Center | |
Denver, Colorado, United States, 80210 | |
United States, District of Columbia | |
George Washington University | |
Washington, District of Columbia, United States, 20037 | |
United States, Florida | |
Florida Hospital | |
Orlando, Florida, United States, 32804 | |
United States, New York | |
Montefiore Medical Center | |
Bronx, New York, United States, 10467 | |
United States, North Carolina | |
East Carolina University | |
Greenville, North Carolina, United States, 27834 | |
United States, Ohio | |
University of Cincinnati Medical Center | |
Cincinnati, Ohio, United States, 45267 | |
Ohio State University | |
Columbus, Ohio, United States, 43210 | |
United States, Pennsylvania | |
Thomas Jefferson University | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Tennessee | |
Ballad Health | |
Johnson City, Tennessee, United States, 37604 | |
Vanderbilt-Ingram Cancer Center | |
Nashville, Tennessee, United States, 37232 | |
United States, Texas | |
UT Southwestern | |
Dallas, Texas, United States, 75390 |
Study Director: | Bryan Oronsky, MD, PhD | EpicentRx, Inc. |
Responsible Party: | EpicentRx, Inc. |
ClinicalTrials.gov Identifier: | NCT03515538 |
Other Study ID Numbers: |
PR-001 |
First Posted: | May 3, 2018 Key Record Dates |
Last Update Posted: | January 11, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
head and neck cancer squamous neck cancer oral cancer |
mucositis sores mouth |
Mucositis Stomatitis Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Mouth Diseases Stomatognathic Diseases Cisplatin Antineoplastic Agents |