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Brief Title: Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma
Official Title: A Phase III Multicenter, International, Randomized, Double-blind, Placebo-controlled Study of Doxorubicin Plus Palifosfamide-tris vs. Doxorubicin Plus Placebo in Patients With Front-line Metastatic Soft Tissue Sarcoma.
Study ID: NCT01168791
Brief Summary: This is an international, randomized, double-blind, placebo-controlled trial to evaluate the clinical efficacy of palifosfamide-tris administered with doxorubicin in combination, compared with doxorubicin administered with placebo in front-line patients diagnosed with metastatic soft tissue sarcoma (STS).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, Birmingham, Alabama, United States
Arizona Oncology Associates, Phoenix, Arizona, United States
, Scottsdale, Arizona, United States
Arizona Cancer Center, Tucson, Arizona, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
University of California, Los Angeles, Los Angeles, California, United States
, Los Angeles, California, United States
University of California, Irvine, Orange, California, United States
, Pomona, California, United States
Sarcoma Oncology Center, Santa Monica, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Rocky Mountain Cancer Centers, Denver, Colorado, United States
Medical Oncology Hematology Consultants, Newark, Delaware, United States
MedStar Research Institute, Washington, District of Columbia, United States
, Washington, District of Columbia, United States
, Jacksonville, Florida, United States
, Orlando, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Palm Beach Cancer Institute, West Palm Beach, Florida, United States
Emory, Atlanta, Georgia, United States
Medical College of Georgia, Augusta, Georgia, United States
Kootenai Cancer Center, Post Falls, Idaho, United States
, Chicago, Illinois, United States
, Park Ridge, Illinois, United States
Indiana University Simon Cancer Center, Indiannapolis, Indiana, United States
University of Iowa Hospital and Clinics, Iowa City, Iowa, United States
Kansas City Cancer Center, Overland Park, Kansas, United States
, New Orleans, Louisiana, United States
LSU Health Sciences Center, Feist-Weiller Cancer Center, Shreveport, Louisiana, United States
, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
, Ann Arbor, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
St.Louis University, St. Louis, Missouri, United States
Washington University School of Medicine, St. Louis, Missouri, United States
, Las Vegas, Nevada, United States
, Hackensack, New Jersey, United States
, Morristown, New Jersey, United States
Saint Barnabas, West Orange, New Jersey, United States
, Albuquerque, New Mexico, United States
, Bronx, New York, United States
Mount Sinai School of Medicine, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
University of Rochester, Rochester, New York, United States
University of North Carolina, Chapel Hill, North Carolina, United States
, Durham, North Carolina, United States
, Raleigh, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Summa Health System, Akron, Ohio, United States
UC Cancer Institute, Cinncinnati, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
The Ohio State University Medical Center, Columbus, Ohio, United States
Cancer Care Associates, Tulsa, Oklahoma, United States
Oregon Health and Science University, Portland, Oregon, United States
, Bethelehem, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Pennsylvania Oncology/Hematology Associates, Philadelphia, Pennsylvania, United States
University of Pittsburgh, Pittsburg, Pennsylvania, United States
, Providence, Rhode Island, United States
, Charleston, South Carolina, United States
Cancer Centers of the Carolinas, Greenville, South Carolina, United States
, Memphis, Tennessee, United States
, Nashville, Tennessee, United States
Texas Oncology, Bedford, Texas, United States
Texas Oncology - Medical City Dallas, Dallas, Texas, United States
Cancer Therapy and Research Center, San Antonio, Texas, United States
Utah Cancer Specialists, Salt Lake City, Utah, United States
, Burlington, Vermont, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
University of Washington/Seattle Cancer Care Alliance, Seattle, Washington, United States
Bellin Cancer Center, Green Bay, Wisconsin, United States
University of Wisconsin, Madison, Wisconsin, United States
, Milwaukee, Wisconsin, United States
, Ciudad de Buenos Aires, , Argentina
, Cordoba, , Argentina
, Ramos Mejia, , Argentina
Instituto CAICI, Rosario, , Argentina
, Sante Fe, , Argentina
North Adelaide Oncology, Adelaide, , Australia
Royal Adelaide Hospital, Adelaide, , Australia
, Camperdown, , Australia
, East Melbourne, , Australia
The Canberra Hospital, Garran, , Australia
, Garran, , Australia
, Kurralta Park, , Australia
, Nedlands, , Australia
Prince of Wales Hospital, Randwick, , Australia
Princess Alexandra Hospital, Woolloongabba, , Australia
, Antwerp, , Belgium
, Bruxelles, , Belgium
, Leuven, , Belgium
, Liege, , Belgium
Institution name: Hospital de Câncer de Barretos - Fundação PIOXII, Barretos, , Brazil
, Belo Horizonte, , Brazil
Santa Casa da Misericórdia de Curitiba, Curitiba, , Brazil
, Florianopolis, , Brazil
, Jau, , Brazil
Hospital da Cidade de Passo Fundo, Passo Fundo, , Brazil
Hospital das Clínicas de Porto Alegre, Porto Alegre, , Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, , Brazil
Centro de Oncologia da Bahia, Salvador, , Brazil
, Sao Paulo, , Brazil
, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
Mount Sinai Hospital, Toronto, Ontario, Canada
Jewish General Hospital, Montreal, Quebec, Canada
McGill University, Montreal, Quebec, Canada
, Santiago, , Chile
Instituto Clínico Oncológico del Sur, Temuco, , Chile
, Vina del Mar, , Chile
, Bogota, , Colombia
, Medellin, , Colombia
, Monteria, , Colombia
, Angers, , France
, Bordeaux, , France
Institut Paoli Calmettes, Marseilles, , France
, Marseille, , France
, Montpellier, , France
, Nice, , France
, Paris, , France
, Toulouse, , France
, Villejuif, , France
HELIOS Klinikum Berlin Buch, Bad Sarrow, , Germany
, Hannover, , Germany
Universitätsklinikum Köln, Koln, , Germany
, Mannheim, , Germany
Tuebingen University Hospital, Tuebingen, , Germany
, Guatemala, , Guatemala
, Jaipur, , India
, Mumbai, , India
, Nasik, , India
, Pune, , India
, Secunderabad, , India
, Haifa, , Israel
Shaare Zedek Medical Center, Jerusalem, , Israel
, Jerusalem, , Israel
, Petach Tikva, , Israel
, Ramat Gan, , Israel
, Ramat-Gan, , Israel
, Tel Aviv, , Israel
, Candiolo, , Italy
Humanitas Cancer Center, Rozzana, , Italy
Ospedale Gradenigo Oncology, Torino, , Italy
Centro Hemato Oncologico Paitilla, Panama, , Panama
Medical and Research Center, Panama, , Panama
Wojewodzkie Centrum Onkologii, Gdansk, , Poland
, Gilwice, , Poland
Centrum Onkologii Instytut, Warszawa, , Poland
, Bucharest, , Romania
, Cluj Napoca, , Romania
, Craiova, , Romania
, Moscow, , Russian Federation
, Obninsk, , Russian Federation
, St. Petersburg, , Russian Federation
, Yaroslavl, , Russian Federation
, Singapore, , Singapore
, Badalona, , Spain
, Madrid, , Spain
Hospital Universitario Puerta de Hierro, Majadahonda, , Spain
, Valencia, , Spain
The Royal Marsden NHS Foundation Trust Sarcoma, London, , United Kingdom
Christie Hospital NHS Foundation Trust, Manchester, , United Kingdom