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NCT03515538 · ClinicalTrials.gov registry record · Phase 2
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, sponsored by EpicentRx.
- Completed
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
NCT03515538: Completed Phase 2 study, sponsored by EpicentRx.
NCT03515538 is a Phase 2 study that has completed, run by EpicentRx. The registered enrollment target is 53 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03515538, a Phase 2 study, has completed, sponsored by EpicentRx.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
Study 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.
Primary Outcome
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 Mu
Interventions
- RADIATION Radiation Therapy
- DRUG RRx-001
- DRUG Cisplatin for injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2018-07-12 |
| Est. Completion | 2020-10-08 |
| Phase | Phase 2 |
What the finished NCT03515538 record still lists
NCT03515538 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 3 interventions - of which Radiation Therapy is the first listed.
NCT03515538 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03515538 about?
NCT03515538 is a clinical study titled "Safety and Efficacy of RRx-001 in the Attenuation of Oral Mucositis in Patients Receiving Chemoradiation for the Treatment of Oral Cancers". 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 give...
What is the current status of trial NCT03515538?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2018-07-12. Estimated completion is 2020-10-08.
What interventions are being tested in trial NCT03515538?
The interventions under investigation include: Radiation Therapy (RADIATION), RRx-001 (DRUG), Cisplatin for injection (DRUG).
Who is sponsoring clinical trial NCT03515538?
This trial is sponsored by EpicentRx, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03515538's enrollment target sits among peer trials
53 1171st of 2000 higher than 820 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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