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Brief Title: DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer
Official Title: A Pivotal, Double-Blind, Randomized, Placebo-Controlled, Multinational Study of SGX942 (Dusquetide) for the Treatment of Oral Mucositis in Patients Being Treated With Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck
Study ID: NCT03237325
Brief Summary: To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis in patients receiving chemoradiation treatment for the treatment of head and neck cancer
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Arizona Clinical Research Center, Tucson, Arizona, United States
Loma Linda University Health, Loma Linda, California, United States
Pomona Valley Hospital Medical Center, Pomona, California, United States
Cancer Specialists of North Florida, Jacksonville, Florida, United States
Lakes Research, Miami Lakes, Florida, United States
University Cancer & Blood, Athens, Georgia, United States
Augusta University, Augusta, Georgia, United States
Memorial Health, Savannah, Georgia, United States
University of Illinois Cancer Center, Chicago, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
Des Moines Oncology Research Association, Des Moines, Iowa, United States
University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States
Ashland Bellefonte Cancer Center, Ashland, Kentucky, United States
Willis Knighton Cancer Center, Shreveport, Louisiana, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Minnesota Oncology, Saint Louis Park, Minnesota, United States
University of Missouri-Ellis Fischel Cancer Center, Columbia, Missouri, United States
Great Falls Clinic, Great Falls, Montana, United States
CHI Health St. Francis, Grand Island, Nebraska, United States
Comprehensive Cancer Centers of Nevada, Henderson, Nevada, United States
Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Hackensack Meridian Health, Neptune, New Jersey, United States
University of Rochester, Rochester, New York, United States
Summa Health Cancer Research, Akron, Ohio, United States
The Christ Hospital, Cincinnati, Ohio, United States
Mercy Clinic Oncology and Hematology, Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists, Tulsa, Oklahoma, United States
Charleston Cancer Center, Charleston, South Carolina, United States
Spartanburg Regional-Gibbs Cancer Center, Spartanburg, South Carolina, United States
University of Virginia, Charlottesville, Virginia, United States
Providence Regional Cancer Partnership, Everett, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Universitair Ziekenhuis Antwerpen, Antwerp, , Belgium
Centre Hospitalier Jolimont, La Louvière, , Belgium
Centre Hospitalier Universitaire de Mons, Mons, , Belgium
CFRO Clinique Pasteur, Brest, , France
Institut Andrée Dutreix, Dunkirk, , France
Clinique Victor Hugo, Le Mans, , France
Hôpital de la Croix Rousse, Lyon, , France
CROM-Osny, Osny, , France
Centre Hospitalier Privé St Grégoire, Saint-Grégoire, , France
Institut Català d'Oncologia Badalona, Badalona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Institut Català d'Oncologia Girona, Girona, , Spain
Hospital Universitario Severo Ochoa, Leganés, , Spain
Hospital Regional Universitario de Málaga, Málaga, , Spain
Hospital Son Llàtzer, Palma De Mallorca, , Spain
Hospital Universitari Son Espases, Palma De Mallorca, , Spain
Hospital Clínico Universitario Lozano Blesa, Zaragoza, , Spain
Aberdeen Royal Infirmary, Aberdeen, , United Kingdom
Edinburgh Cancer Centre, Edinburgh, , United Kingdom
Guy's Hospital, London, , United Kingdom
Weston Park Hospital, Sheffield, , United Kingdom