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Spots Global Cancer Trial Database for ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients

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Trial Identification

Brief Title: ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients

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

Study ID: NCT03689712

Conditions

Oral Mucositis

Interventions

GC4419 90mg
Placebo

Study Description

Brief Summary: 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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States

Fowler Family Center for Cancer, Jonesboro, Arkansas, United States

The Oncology Institute of Hope & Innovation, Corona, California, United States

Chan Soon-Shiong Institute for Medicine, Costa Mesa, California, United States

Long Beach Veteran Affairs Healthcare System, Long Beach, California, United States

USC Norris Cancer Center, Los Angeles, California, United States

Cedars-Sinai Medical Center, Los Angeles, California, United States

Clinical Trials and Research Associates, Inc., Montebello, California, United States

Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States

Compassionate Cancer Care, Riverside, California, United States

Sharp Clinical Oncology Research, San Diego, California, United States

The Oncology Institute of Hope & Innovation, Whittier, California, United States

Dignity Health Research Institute, Woodland, California, United States

St. Mary's Hospital Regional Medical Center, Grand Junction, Colorado, United States

Bay Pines VA HealthCare System, Bay Pines, Florida, United States

Boca Raton Regional Hospital, Lynn Cancer Institute, Boca Raton, Florida, United States

Mayo Clinic Florida, Jacksonville, Florida, United States

Cancer Specialists of North Florida, Jacksonville, Florida, United States

Lakeland Regional Cancer Center, Lakeland, Florida, United States

BRCR Global, Plantation, Florida, United States

Winship Cancer Institute of Emory University, Atlanta, Georgia, United States

IACT Health, Columbus, Georgia, United States

Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States

SwedishAmerican Regional Cancer Center, Rockford, Illinois, United States

Parkview Research Center, Fort Wayne, Indiana, United States

Goshen Center for Cancer Care, Goshen, Indiana, United States

The University of Iowa Hospitals & Clinics, Iowa City, Iowa, United States

Appalachian Regional Healthcare, INC., Hazard, Kentucky, United States

University of Louisville/James Graham Brown Cancer Center, Louisville, Kentucky, United States

Norton Cancer Institute, Louisville, Kentucky, United States

MetroWest Medical Center, Framingham, Massachusetts, United States

University of Michigan, Ann Arbor, Michigan, United States

Minneapolis VA Healthcare System, Minneapolis, Minnesota, United States

Hattiesburg Clinic Hematology/Oncology, Hattiesburg, Mississippi, United States

Henry Ford Allegiance Health Hematology Oncology, Jackson, Mississippi, United States

Ellis Fischel Cancer Center - University of Missouri, Columbia, Missouri, United States

Delbert Day Cancer Institute, Phelps County Regional Medical Center, Rolla, Missouri, United States

Mosaic Life Care/Heartland Regional Medical Center, Saint Joseph, Missouri, United States

Cox Medical Center, Springfield, Missouri, United States

St. Vincent Frontier Cancer Center, Billings, Montana, United States

Benefis Sletten Cancer institute, Great Falls, Montana, United States

CHI Health St. Francis, Grand Island, Nebraska, United States

Renown Regional Medical Center, Reno, Nevada, United States

Exeter Hospital, Exeter, New Hampshire, United States

Hunterdon Hematology Oncology, LLC, Flemington, New Jersey, United States

Summit Medical Group, Florham Park, New Jersey, United States

Jersey Shore University Medical Center, Neptune, New Jersey, United States

New York Oncology Hematology, P.C., Albany, New York, United States

NY Cancer and Blood Specialists, East Setauket, New York, United States

New York- Presbyterian Queens/ Weill Cornell, Flushing, New York, United States

Wilmot Cancer Institute - Univeristy of Rochester, Rochester, New York, United States

School of Dental Medicine at East Carolina University, Greenville, North Carolina, United States

Wake Forest Baptist Health, Winston-Salem, North Carolina, United States

Summa Health, Akron, Ohio, United States

University Hospitals Seidman Cancer Center, Cleveland, Ohio, United States

The Ohio State University, Columbus, Ohio, United States

Willamette Valley Cancer Institue and Research Center, Eugene, Oregon, United States

VA Portland Health Care System, Portland, Oregon, United States

St. Luke's Hospital Cancer Center, Easton, Pennsylvania, United States

Gettysburg Cancer Center, Gettysburg, Pennsylvania, United States

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

Anmed Health Cancer Center, Anderson, South Carolina, United States

Charleston Cancer Center, Charleston, South Carolina, United States

St. Francis Cancer Center, Greenville, South Carolina, United States

Spartanburg Medical Center, Spartanburg, South Carolina, United States

Mountain States Health Alliance Research Dept, Johnson City, Tennessee, United States

Tennessee Cancer Specialists, Knoxville, Tennessee, United States

University of Tennessee Medical Center, Knoxville, Tennessee, United States

Texas Oncology - Beaumont Mamie McFaddin Ward Cancer Center, Beaumont, Texas, United States

Texas Oncology- Dallas Presbyterian Hospital, Dallas, Texas, United States

Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States

Texas Oncology - Denton South, Denton, Texas, United States

Texas Oncology - El Paso Cancer Treatment Center, El Paso, Texas, United States

SAMMC, Fort Sam Houston, Texas, United States

Texas Oncology-McAllen, McAllen, Texas, United States

Texas Oncology - McKinney, McKinney, Texas, United States

Texas Oncology, Plano West, Plano, Texas, United States

Baylor Scott & White- Round Rock, Round Rock, Texas, United States

Texas Oncology - Sugar Land, Sugar Land, Texas, United States

Texas Oncology - Waco, Waco, Texas, United States

Fort Belvoir Community Hospital, Fort Belvoir, Virginia, United States

Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care, Roanoke, Virginia, United States

Providence Regional Cancer Partnership, Everett, Washington, United States

Cancer Care Northwest, Spokane, Washington, United States

West Virginia University, Morgantown, West Virginia, United States

BC Cancer Center - Vancouver, Vancouver, British Columbia, Canada

CIUSS de L'Est-de-I'lle de Montreal - Hopital Maisonneuve- Rosemont, Montréal, Quebec, Canada

McGill University Health Center- Cedars Cancer Center, Montréal, Quebec, Canada

CHU de Quebec - Universite Laval, Québec, Quebec, Canada

Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay-Lac-Saint-Jean, Chicoutimi, , Canada

Juravinski Cancer Centre, Hamilton, , Canada

Centre Hospitalier Universitaire de Montreal (CHUM), Montréal, , Canada

Jewish General Hospital, Montréal, , Canada

Northeast Cancer Centre of Health Sciences North, Sudbury, , Canada

Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie et du Centre du Québec, Trois-Rivières, , Canada

Clinical Research Puerto Rico, San Juan, , Puerto Rico

Contact Details

Name: Gene Kennedy, MD

Affiliation: Galera Therapeutics

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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