A Study of the Effects of GC4419 on Radiation Induced Oral Mucositis in Patients With Head/Neck Cancer
Public ClinicalTrials.gov record NCT02508389. 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
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial of the Effects of GC4419 on Severe Oral Mucositis in Patients Receiving Cisplatin + Intensity-modulated Radiation Therapy (IMRT) for Locally Advanced Non-Metastatic Squamous Cell Carcinoma (SCC) of the Oral Cavity/Oropharynx
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the phase 2, GT-201 clinical study is to determine if GC4419 administered prior to intensity-modulated radiation therapy (IMRT) reduces the incidence, duration, and 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
- NCT02508389
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 223 participants
Conditions and interventions
Conditions
Interventions
- Low Dose GC4419: 30mg/day Drug
- High Dose GC4419: 90mg/day Drug
- Placebo Drug
- Intensity-Modulated Radiation Therapy Radiation
- Cisplatin Drug
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
- Oct 12, 2015 (Type not available)
- Primary completion
- Sep 18, 2017 (Actual)
- Completion
- Aug 29, 2019 (Actual)
- Last update posted
- Sep 20, 2021
2015 – 2019
United States locations
- U.S. sites
- 60
- U.S. states
- 31
- U.S. cities
- 58
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arizona Cancer Center at Dignity Health St. Joseph's | Phoenix | Arizona | 85004 | — |
| University of Arizona | Tucson | Arizona | 85724 | — |
| Fowler Family Center for Cancer Care | Jonesboro | Arkansas | 72401 | — |
| University of Arkansas for Medical Sciences- Winthrop P. Rockefeller Cancer Institute | Little Rock | Arkansas | 72205 | — |
| VA Long Beach Healthcare System | Long Beach | California | 90822 | — |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| Clinical Trials and Research Associates, Inc. | Montebello | California | 90604 | — |
| UC Irvine Chao Family Comprehensive Cancer Center | Orange | California | 92868 | — |
| Stanford Cancer Institute | Stanford | California | 94305 | — |
| St. Mary's Regional Cancer Center | Grand Junction | Colorado | 81501 | — |
| UConn Health School of Dental Medicine | Farmington | Connecticut | 06030 | — |
| Pasco Pinellas Cancer Center | Holiday | Florida | 34691 | — |
| Lakeland Regional Health Cancer Center | Lakeland | Florida | 32504 | — |
| UF Health Cancer Center at Orlando Health | Orlando | Florida | 32806 | — |
| Sacred Heart Medical Oncology Group | Pensacola | Florida | 32504 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| University of Indianan, Goshen Center for Cancer Care | Goshen | Indiana | 46526 | — |
| Department of Radiation Oncology University of Iowa Hospitals & Clinics | Iowa City | Iowa | 52242 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Ashland-Bellefonte Cancer Center | Ashland | Kentucky | 41101 | — |
| University of Kentucky, Albert B. Chandler Medical Center | Lexington | Kentucky | 40536 | — |
| University of Louisville Hospital, James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | — |
| Tulane Cancer Center | New Orleans | Louisiana | 70112 | — |
| CHRISTUS Schumpert Cancer Treatment Center | Shreveport | Louisiana | 71101 | — |
| Baystate Regional Cancer Program | Springfield | Massachusetts | 01199 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Henry Ford Allegiance Health | Jackson | Michigan | 49201 | — |
| Lake Huron Medical Center | Port Huron | Michigan | 48060 | — |
| Ellis Fichel Cancer Center, University of Missouri | Columbia | Missouri | 65212 | — |
| Billings Clinic | Billings | Montana | 59101 | — |
| St. Vincent Frontier Cancer Center | Billings | Montana | 59102 | — |
| Renown Cancer Institute | Reno | Nevada | 89502 | — |
| Hunterdon Hematology Oncology, LLC Hunterdon Regional Cancer Center | Flemington | New Jersey | 08822 | — |
| Jersey Shore University Medical Center- Hackensack Meridian Health | Neptune City | New Jersey | 07753 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| East Carolina University, Leo W. Jenkins Cancer Center | Greenville | North Carolina | 27834 | — |
| Marion L. Shepard Cancer Center | Washington | North Carolina | 27889 | — |
| Wake Forest Health | Winston-Salem | North Carolina | 27157 | — |
| Ohio State University, James Cancer Center | Columbus | Ohio | 43210 | — |
| Toledo Clinic Cancer Center | Toledo | Ohio | 43623 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| VA Portland Health Care System | Portland | Oregon | 97239 | — |
| St. Luke's University Health Network | Easton | Pennsylvania | 18045 | — |
| Thomas-Jefferson University Hospital-Bodine Center for Cancer Treatment | Philadelphia | Pennsylvania | 19107 | — |
| Allegheny General Hospital, Allegheny Cancer Center | Pittsburgh | Pennsylvania | 15212 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| AnMed Health Cancer Center | Anderson | South Carolina | 29621 | — |
| Charleston Cancer Center | Charleston | South Carolina | 29406 | — |
| Spartanburg Medical Center | Spartanburg | South Carolina | 29303 | — |
| Prairie Lakes Health Care System | Watertown | South Dakota | 57201 | — |
| Mountain States Health Alliance | Johnson City | Tennessee | 36704 | — |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | — |
| Texas Oncology | Plano | Texas | 75093 | — |
| Scott and White Memorial Hospital and Clinic | Temple | Texas | 76508 | — |
| Hope Cancer Center | Tyler | Texas | 75701 | — |
| The University of Vermont Medical Center | Burlington | Vermont | 05401 | — |
| Providence Regional Medical Center | Everett | Washington | 98201 | — |
| VA Puget Sound Health Care System | Seattle | Washington | 98108 | — |
| 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 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02508389, 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 Sep 20, 2021 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02508389 live on ClinicalTrials.gov.