Spots Global Cancer Trial Database for Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma
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Trial Identification
Brief Title: Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma
Official Title: A Randomized Phase III Study of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery Alone for Patients With High Risk RetroPeritoneal Sarcoma (RPS)
Study ID: NCT04031677
Study Description
Brief Summary: This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival. After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.
Detailed Description: Standard arm: * Large en-bloc curative-intent surgery within 4 weeks following randomization- Experimental arm Experimental arm: * 3 cycles of neoadjuvant chemotherapy starting within 2 weeks following randomization: * High grade LPS: ADM (doxorubicin) 75 mg/m2 (or the equivalent EpiADM 120 mg/m2) + ifosfamide 9 g/m3 Q3 weeks. * LMS: ADM 75 mg/m2 + DTIC (dacarbazine) 1 g/m2 Q3 weeks * re-assessment of operability * curative-intent surgery within 3-6 weeks of last cycle of chemotherapy
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
UC Irvine Health/Chao Family Comprehensive Ca Ctr, Orange, California, United States
UCHealth University of Colorado Hospital, Aurora, Colorado, United States
Smilow Cancer Hospital-Derby Care Center, Derby, Connecticut, United States
Smilow Cancer Hospital Care Center-Fairfield, Fairfield, Connecticut, United States
Smilow Cancer Hospital Care Center at Glastonbury, Glastonbury, Connecticut, United States
Smilow Cancer Hospital Care Center at Greenwich, Greenwich, Connecticut, United States
Smilow Cancer Hospital Care Center - Guiford, Guilford, Connecticut, United States
Smilow Cancer Hospital Care Ctr at Saint Francis, Hartford, Connecticut, United States
Yale University, New Haven, Connecticut, United States
Yale-New Haven Hospital North Haven Medical Center, North Haven, Connecticut, United States
Smilow Cancer Hospital Care Center at Long Ridge, Stamford, Connecticut, United States
Smilow Cancer Hospital Care Center-Trumbull, Trumbull, Connecticut, United States
Smilow Cancer Hospital-Waterbury Care Center, Waterbury, Connecticut, United States
Smilow Cancer Hospital Care Center - Waterford, Waterford, Connecticut, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
Moffitt Cancer Center-International Plaza, Tampa, Florida, United States
Moffitt Cancer Center - McKinley Campus, Tampa, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Emory University Hospital Midtown, Atlanta, Georgia, United States
Northwestern University, Chicago, Illinois, United States
University of Illinois at Chicago MBCCOP, Chicago, Illinois, United States
University of Kansas Cancer Center, Kansas City, Kansas, United States
University of Kansas Cancer Center-Overland Park, Overland Park, Kansas, United States
University of Kansas Hospital-Westwood Cancer Ctr, Westwood, Kansas, United States
LSU Health Baton Rouge-North Clinic, Baton Rouge, Louisiana, United States
Our Lady of The Lake Hospital, Baton Rouge, Louisiana, United States
Our Lady of the Lake Physician Group, Baton Rouge, Louisiana, United States
Johns Hopkins Univ/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Dana-Farber/Harvard Cancer Center, Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Sanford Joe Lueken Cancer Center, Bemidji, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Siteman Cancer Center-West County, Creve Coeur, Missouri, United States
Washington University School of Medicine - Siteman Cancer Center, Saint Louis, Missouri, United States
Siteman Cancer Center-South Country, Saint Louis, Missouri, United States
Nebraska Medicine-Bellevue, Bellevue, Nebraska, United States
Nebraska Medicine-Bellevue, Omaha, Nebraska, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Dartmouth Hitchcock Med Ctr/Dartmouth Cancer Ctr, Lebanon, New Hampshire, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
University of Rochester, Rochester, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Sanford Bismarck Medical Center, Bismarck, North Dakota, United States
Sanford Broadway Medical Center, Fargo, North Dakota, United States
Sanford Roger Maris Cancer Center, Fargo, North Dakota, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Oregon Health and Science University, Portland, Oregon, United States
University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, United States
Pennsylvania Hospital, Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Smilow Cancer Hospital Care Center - Westerly, Westerly, Rhode Island, United States
Sanford Cancer Center Oncology Clinic, Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States
M D Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
VCU Massey Cancer Center at Hanover Medical Park, Mechanicsville, Virginia, United States
VCU Massey Cancer Center at Stony Point, Richmond, Virginia, United States
Virginia Commonwealth Univ/Massey Cancer Center, Richmond, Virginia, United States
Carilion Roanoke Memorial Hospital, Roanoke, Virginia, United States
VCU Community Memorial Health Center, South Hill, Virginia, United States
FHCC South Lake Union, Seattle, Washington, United States
Fred Hutchinson Cancer Center, Seattle, Washington, United States
University of Washington Medical Center - Montlake, Seattle, Washington, United States
Marshfield Medical Center-EC Cancer Center, Eau Claire, Wisconsin, United States
Marshfield Medical Center, Marshfield, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Marshfield Medical Center, Minocqua, Wisconsin, United States
Marshfield Medical Center, Rice Lake, Wisconsin, United States
Marshfield Med Ctr-River Region at Stevens Point, Stevens Point, Wisconsin, United States
Marshfield Medical Center, Weston, Wisconsin, United States
Princess Alexandra Hospital - University Of Queensland, Woolloongabba, Queensland, Australia
Peter Maccallum Cancer Institute, Melbourne, Victoria, Australia
Chris O'Brian Life House - Chris O'Brien Lifehouse, Camperdown, , Australia
BCCA - Vancouver Cancer Centre, Vancouver, British Columbia, Canada
London Regional Cancer Center, London, Ontario, Canada
The Ottawa Hospital - General Campus, Ottawa, Ontario, Canada
Hopital Maisonneuve Rosemont, Montréal, Quebec, Canada
The Research Institute of the McGill University Health Centre, Montréal, Quebec, Canada
Mount Sinai Hospital, Toronto, , Canada
Bank Of Cyprus Oncology Centre, Stróvolos, , Cyprus
Masaryk Memorial Cancer Institute, Brno, , Czechia
Herlev Hospital - University Copenhagen, Herlev, Copenhagen, Denmark
Aarhus University Hospitals - Aarhus University Hospital-Skejby, Aarhus, , Denmark
Centre Leon Berard, Lyon, , France
Institut du Cancer de Montpellier, Montpellier, , France
Institut Curie- Hopital de Paris, Paris, , France
Hopitaux Universitaires de Strasbourg - Hautepierre, Strasbourg, , France
Institut Gustave Roussy, Villejuif, , France
Universitaetsmedizin Goettingen - Georg-August Universitaet, Goettigen, Lower Saxony, Germany
Universitaetsklinikum Carl Gustav Carus, Dresden, , Germany
UniversitaetsMedizin Mannheim, Mannheim, , Germany
Centro Di Riferimento Oncologico, Aviano, , Italy
IRCCS - Fondazione Piemonte Inst di Candiolo, Candiolo, , Italy
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, , Italy
Istituto Clinico Humanitas, Milano, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
IRCCS - Istituto Nazionale dei Tumori, Milan, , Italy
IRCCS - Istituto Oncologico Veneto, Padova, , Italy
Policlinico Universitario Campus Bio-Medico- Oncology Center, Roma, , Italy
Kyushu University Hospital, Higashi-ku, Fukuoka, Japan
Yokohama City University Hospital, Yokohama, Kanagawa, Japan
Kanagawa Cancer Center, Yokohama, Kanagawa, Japan
Tohoku University Hospital, Sendai, Miyagi, Japan
Aichi Cancer Center, Chikusa-ku, Nagoya, Japan
Nagoya University Hospital, Showa-ku, Nagoya, Japan
Niigata University Medical and Dental Hospital, Niigata City, Niigata, Japan
Okayama University Hospital, Kita-ku, Okayama, Japan
Osaka International Cancer Institute, Chuo-ku, Osaka, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
Cancer Institute Hospital of JFCR, Koto-ku, Tokyo, Japan
Saitama Medical Center, Jichi Medical University, Saitama, , Japan
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis, Amsterdam, , Netherlands
Leiden University Medical Centre, Leiden, , Netherlands
Radboudumc - Radboud University Medical Center Nijmegen, Nijmegen, , Netherlands
Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, , Poland
National Cancer Institute, Bratislava, , Slovakia
Hospital De La Santa Creu I Sant Pau, Barcelona, , Spain
Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol, Barcelona, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Hospital Universitario San Carlos, Madrid, , Spain
University Hospitals Birmingham - Queen Elisabeth Medical Centre, Birmingham, , United Kingdom
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital, Glasgow, , United Kingdom
Leeds Teaching Hospitals NHS Trust - St. James's University Hospital, Leeds, , United Kingdom
the Royal Marsden Hospital, London, , United Kingdom
Newcastle Hospitals - Freeman Hospital, Northern Centre For Cancer Care, Newcastle, , United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital, Nottingham, , United Kingdom
Oxford University Hospitals NHS Trust - Churchill Hospital, Oxford, , United Kingdom
Clatterbridge cancer center, Wirral, , United Kingdom
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