ClinicalTrials.gov record
ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients
ClinicalTrials.gov ID: NCT03689712
Public ClinicalTrials.gov record NCT03689712. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
ROMAN: Reduction in Oral Mucositis With Avasopasem Manganese (GC4419) - Phase 3 Trial in Patients Receiving Chemoradiotherapy for Locally-Advanced, Non-Metastatic Head and Neck Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the phase 3, clinical study is to determine if GC4419 (avasopasem manganese) administered prior to intensity-modulated radiation therapy (IMRT) reduces the severity of radiation induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.
Study identification
- NCT ID
- NCT03689712
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 455 participants
Conditions and interventions
Conditions
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
- Oct 3, 2018 (Actual)
- Primary completion
- Aug 13, 2021 (Actual)
- Completion
- Aug 25, 2023 (Actual)
- Last update posted
- Oct 24, 2023
2018 – 2023
United States locations
- U.S. sites
- 86
- U.S. states
- 31
- U.S. cities
- 80
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | — |
| Fowler Family Center for Cancer | Jonesboro | Arkansas | 72401 | — |
| The Oncology Institute of Hope & Innovation | Corona | California | 92882 | — |
| Chan Soon-Shiong Institute for Medicine | Costa Mesa | California | 92627 | — |
| Long Beach Veteran Affairs Healthcare System | Long Beach | California | 90822 | — |
| USC Norris Cancer Center | Los Angeles | California | 90033 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Clinical Trials and Research Associates, Inc. | Montebello | California | 90640 | — |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92663 | — |
| Compassionate Cancer Care | Riverside | California | 92501 | — |
| Sharp Clinical Oncology Research | San Diego | California | 92123 | — |
| The Oncology Institute of Hope & Innovation | Whittier | California | 90603 | — |
| Dignity Health Research Institute | Woodland | California | 95695 | — |
| St. Mary's Hospital Regional Medical Center | Grand Junction | Colorado | 81501 | — |
| Bay Pines VA HealthCare System | Bay Pines | Florida | 33744 | — |
| Boca Raton Regional Hospital, Lynn Cancer Institute | Boca Raton | Florida | 33486 | — |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | — |
| Cancer Specialists of North Florida | Jacksonville | Florida | 32256 | — |
| Lakeland Regional Cancer Center | Lakeland | Florida | 33805 | — |
| BRCR Global | Plantation | Florida | 33322 | — |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | — |
| IACT Health | Columbus | Georgia | 31904 | — |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | — |
| SwedishAmerican Regional Cancer Center | Rockford | Illinois | 61114 | — |
| Parkview Research Center | Fort Wayne | Indiana | 46845 | — |
| Goshen Center for Cancer Care | Goshen | Indiana | 46526 | — |
| The University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | — |
| Appalachian Regional Healthcare, INC. | Hazard | Kentucky | 41701 | — |
| University of Louisville/James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | — |
| Norton Cancer Institute | Louisville | Kentucky | 40241 | — |
| MetroWest Medical Center | Framingham | Massachusetts | 01702 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Minneapolis VA Healthcare System | Minneapolis | Minnesota | 55417 | — |
| Hattiesburg Clinic Hematology/Oncology | Hattiesburg | Mississippi | 39401 | — |
| Henry Ford Allegiance Health Hematology Oncology | Jackson | Mississippi | 49201 | — |
| Ellis Fischel Cancer Center - University of Missouri | Columbia | Missouri | 65212 | — |
| Delbert Day Cancer Institute, Phelps County Regional Medical Center | Rolla | Missouri | 65401 | — |
| Mosaic Life Care/Heartland Regional Medical Center | Saint Joseph | Missouri | 64507 | — |
| Cox Medical Center | Springfield | Missouri | 65807 | — |
| St. Vincent Frontier Cancer Center | Billings | Montana | 59102 | — |
| Benefis Sletten Cancer institute | Great Falls | Montana | 59405 | — |
| CHI Health St. Francis | Grand Island | Nebraska | 68803 | — |
| Renown Regional Medical Center | Reno | Nevada | 89502 | — |
| Exeter Hospital | Exeter | New Hampshire | 03833 | — |
| Hunterdon Hematology Oncology, LLC | Flemington | New Jersey | 08822 | — |
| Summit Medical Group | Florham Park | New Jersey | 07932 | — |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | — |
| New York Oncology Hematology, P.C. | Albany | New York | 12206 | — |
| NY Cancer and Blood Specialists | East Setauket | New York | 11733 | — |
| New York- Presbyterian Queens/ Weill Cornell | Flushing | New York | 11355 | — |
| Wilmot Cancer Institute - Univeristy of Rochester | Rochester | New York | 14642 | — |
| School of Dental Medicine at East Carolina University | Greenville | North Carolina | 27834 | — |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | — |
| Summa Health | Akron | Ohio | 44304 | — |
| University Hospitals Seidman Cancer Center | Cleveland | Ohio | 44106 | — |
| The Ohio State University | Columbus | Ohio | 43210 | — |
| Willamette Valley Cancer Institue and Research Center | Eugene | Oregon | 97401 | — |
| VA Portland Health Care System | Portland | Oregon | 97239 | — |
| St. Luke's Hospital Cancer Center | Easton | Pennsylvania | 18045 | — |
| Gettysburg Cancer Center | Gettysburg | Pennsylvania | 17325 | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| Anmed Health Cancer Center | Anderson | South Carolina | 29621 | — |
| Charleston Cancer Center | Charleston | South Carolina | 29406 | — |
| St. Francis Cancer Center | Greenville | South Carolina | 29607 | — |
| Spartanburg Medical Center | Spartanburg | South Carolina | 29303 | — |
| Mountain States Health Alliance Research Dept | Johnson City | Tennessee | 37604 | — |
| Tennessee Cancer Specialists | Knoxville | Tennessee | 37909 | — |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | — |
| Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center | Beaumont | Texas | 77702 | — |
| Texas Oncology- Dallas Presbyterian Hospital | Dallas | Texas | 75231 | — |
| Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | — |
| Texas Oncology - Denton South | Denton | Texas | 76210 | — |
| Texas Oncology - El Paso Cancer Treatment Center | El Paso | Texas | 79902 | — |
| SAMMC | Fort Sam Houston | Texas | 78234 | — |
| Texas Oncology-McAllen | McAllen | Texas | 78503 | — |
| Texas Oncology - McKinney | McKinney | Texas | 75071 | — |
| Texas Oncology, Plano West | Plano | Texas | 75093 | — |
| Baylor Scott & White- Round Rock | Round Rock | Texas | 78665 | — |
| Texas Oncology - Sugar Land | Sugar Land | Texas | 77479 | — |
| Texas Oncology - Waco | Waco | Texas | 76712 | — |
| Fort Belvoir Community Hospital | Fort Belvoir | Virginia | 22060 | — |
| Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care | Roanoke | Virginia | 24014 | — |
| Providence Regional Cancer Partnership | Everett | Washington | 98201 | — |
| Cancer Care Northwest | Spokane | Washington | 99216 | — |
| West Virginia University | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 11 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03689712, 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 Oct 24, 2023 · Synced Oct 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03689712 live on ClinicalTrials.gov.