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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
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Gene Kennedy, MD
Affiliation: Galera Therapeutics
Role: STUDY_CHAIR