Oral MucositisPhase 2PREVLARNCT03515538
Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers
A Phase 2 study testing RRx-001, Cisplatin for injection and Radiation Therapy in people with Oral Mucositis, run by EpicentRx, Inc. at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- RRx-001, Cisplatin for injection and Radiation Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 12 sitesUnited States
- Study dates
- 12 Jul 2018to 8 Oct 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Participants must have adequate organ and marrow function as defined below:
- Absolute neutrophil count (ANC) >1,500 / mm3 B. Platelets > 100,000 / mm3 C. Hemoglobin ≥ 9.0 g/dL
- Adequate renal and liver function as indicated by:
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- 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.
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
Ohio State University
Columbus, Ohio, 43210
UT Southwestern
Dallas, Texas, 75390
Centura Health Research Center
Denver, Colorado, 80210
East Carolina University
Greenville, North Carolina, 27834
Ballad Health
Johnson City, Tennessee, 37604
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Florida Hospital
Orlando, Florida, 32804
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
John Wayne Cancer Institute @ Providence St. John's Health Center
Santa Monica, California, 90401
Montefiore Medical Center
The Bronx, New York, 10467
George Washington University
Washington D.C., District of Columbia, 20037
About this study
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
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.
Read the 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.
- Conditions
- Oral Mucositis
- Being tested
- RRx-001, Cisplatin for injection, Radiation Therapy
- Keywords
- head and neck cancer, squamous, neck cancer, oral cancer, mucositis, sores, mouth
- Medical subject headings
- Stomatitis, Head and Neck Neoplasms, Mouth Neoplasms, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RRx-001Drug
RRx-001 for injection
Cisplatin for injectionDrug
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 TherapyRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| RRx-001 Pre-Treatment plus SOC | Experimental | 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 Receives: Drug: RRx-001; Drug: Cisplatin for injection; Radiation: Radiation Therapy |
| RRx-001 Pre-Treatment, 2 Concurrent Doses plus SOC | Experimental | 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 Receives: Drug: RRx-001; Drug: Cisplatin for injection; Radiation: Radiation Therapy |
| RRx-001 Pre-Treatment, 6 Concurrent Doses plus SOC | Experimental | 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 Receives: Drug: RRx-001; Drug: Cisplatin for injection; Radiation: Radiation Therapy |
| Standard of Care | Active comparator | 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). Receives: Drug: Cisplatin for injection; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Severe Oral Mucositis (SOM)
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 4 = oral alimentation impossible. Severe 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 Severe Oral Mucositis duration numbers are indicative of worst outcomes. The total Severe 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.
Measured: From start of treatment through 28 days post treatment for up to 11 weeks from Start of Treatment
Secondary outcomes (3)
Time to Onset of Severe Oral Mucositis
Time to onset of Severe Oral Mucositis defined as time (in days) from randomization to the first observed Severe Oral Mucositis. Longer Severe Oral Mucositis onset times are indicative of a better outcome. The time to onset of Severe 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.
Measured: Time from Day 1 to Oral Mucositis Onset (up to 8 weeks)
Incidence of Severe Oral Mucositis
Incidence of Severe Oral Mucositis defined as the number of patients who experienced a Severe Oral Mucositis grade 4 during the randomized treatment period.
Measured: Baseline through end of treatment (up to 11 weeks). Data collected every week.
Opioid Use
Opioid use from the time to onset (TTO) and duration of opioid use among patients who were not taking opioids at radiation start or who required a second opioid during active treatment.
Measured: Baseline through end of radiation treatment (through 8 weeks). Data collected every week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study start12 Jul 2018
- Primary completion22 Oct 2019
- Study completion8 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- EpicentRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Prothex, Inc.
- Responsible party
- Sponsor
- Investigators
- Bryan Oronsky, MD, PhD, Study director, EpicentRx, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515538
- Sponsor's protocol ID
- PR-001
- Acronym
- PREVLAR
- Status last verified
- Oct 2024
- First submitted
- 18 Apr 2018
- Last updated
- 4 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03515538
- Acronym / sponsor ID
- PREVLAR / PR-001
- Conditions
- Oral Mucositis
- Keywords
- head and neck cancer, squamous, neck cancer, oral cancer, mucositis, sores, mouth
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- EpicentRx, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Prothex, Inc.
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 22 Oct 2019 (actual)
- Study completion
- 8 Oct 2020 (actual)
- First posted
- 3 May 2018 (actual)
- Results
- Posted 4 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RRx-001 Pre-Treatment plus SOC | Experimental | Drug: RRx-001, Drug: Cisplatin for injection, Radiation: Radiation TherapyTwo 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 |
| RRx-001 Pre-Treatment, 2 Concurrent Doses plus SOC | Experimental | Drug: RRx-001, Drug: Cisplatin for injection, Radiation: Radiation TherapyTwo 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 |
| RRx-001 Pre-Treatment, 6 Concurrent Doses plus SOC | Experimental | Drug: RRx-001, Drug: Cisplatin for injection, Radiation: Radiation TherapyTwo 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 |
| Standard of Care | Active comparator | Drug: Cisplatin for injection, Radiation: Radiation TherapyNo 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
- Participants must have adequate organ and marrow function as defined below:
- Adequate renal and liver function as indicated by:
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RRx-001RRx-001 for injection | Drug | RRx-001 Pre-Treatment plus SOC, RRx-001 Pre-Treatment, 2 Concurrent Doses plus SOC, RRx-001 Pre-Treatment, 6 Concurrent Doses plus SOC |
| Cisplatin for injectionPatients 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 | Drug | RRx-001 Pre-Treatment plus SOC, RRx-001 Pre-Treatment, 2 Concurrent Doses plus SOC, RRx-001 Pre-Treatment, 6 Concurrent Doses plus SOC, Standard of Care |
| Radiation TherapyIntensity 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 | Radiation | RRx-001 Pre-Treatment plus SOC, RRx-001 Pre-Treatment, 2 Concurrent Doses plus SOC, RRx-001 Pre-Treatment, 6 Concurrent Doses plus SOC, Standard of Care |
Primary outcome
Duration of Severe Oral Mucositis (SOM)
Time frame: From start of treatment through 28 days post treatment for up to 11 weeks from Start of Treatment
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 4 = oral alimentation impossible. Severe 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 Severe Oral Mucositis duration numbers are indicative of worst outcomes. The total Severe 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.
3 secondary outcomes
Time to Onset of Severe Oral Mucositis
Time frame: Time from Day 1 to Oral Mucositis Onset (up to 8 weeks)
Incidence of Severe Oral Mucositis
Time frame: Baseline through end of treatment (up to 11 weeks). Data collected every week.
Opioid Use
Time frame: Baseline through end of radiation treatment (through 8 weeks). Data collected every week.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryan Oronsky, MD, PhD study director
EpicentRx, Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RRx-001, Cisplatin for injection and Radiation Therapy in people with Oral Mucositis, run by EpicentRx, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Severe Oral Mucositis (SOM) (time frame: From start of treatment through 28 days post treatment for up to 11 weeks from Start of Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.