Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma
Start Date
1/20/2021
Completion Date
4/21/2028
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
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Surgery
Preoperative chemotherapy
Conditions
Locations
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233
United States
Mayo Clinic Hospital in Arizona
Phoenix, Arizona 85054
United States
City of Hope Comprehensive Cancer Center
Duarte, California 91010
United States
UCI Health-Chao Family Comp CC and Ambulatory Care
Irvine, California 92612
United States
UC San Diego Moores Cancer Center
La Jolla, California 92093
United States
UC Irvine Health/Chao Family Comprehensive Ca Ctr
Orange, California 92668
United States
UCHealth University of Colorado Hospital
Aurora, Colorado 80045
United States
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut 06418
United States
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut 06824
United States
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut 06033
United States
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut 06830
United States
Smilow Cancer Hospital Care Center - Guiford
Guilford, Connecticut 06437
United States
Smilow Cancer Hospital Care Ctr at Saint Francis
Hartford, Connecticut 06105
United States
Yale University
New Haven, Connecticut 06520
United States
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut 06385
United States
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut 06902
United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut 06611
United States
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut 06708
United States
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut 06385
United States
Univ of Florida Health Science Ctr - Gainesville
Gainesville, Florida 32610
United States
Mayo Clinic in Florida
Jacksonville, Florida 32224
United States
Moffitt Cancer Center-International Plaza
Tampa, Florida 33607
United States
Moffitt Cancer Center - McKinley Campus
Tampa, Florida 33612
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
Emory University Hospital Midtown
Atlanta, Georgia 30308
United States
Northwestern University
Chicago, Illinois 60611
United States
Rush University Medical Center
Chicago, Illinois 60612
United States
University of Illinois at Chicago MBCCOP
Chicago, Illinois 60612
United States
Indiana Univ/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
United States
University of Kansas Cancer Center
Kansas City, Kansas 66160
United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas 66210
United States
University of Kansas Hospital-Westwood Cancer Ctr
Westwood, Kansas 66205
United States
James Graham Brown Ca Ctr at Univ of Louisville
Louisville, Kentucky 40202
United States
UofL Health Medical Center Northeast
Louisville, Kentucky 40245
United States
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana 70805
United States
Our Lady of The Lake Hospital
Baton Rouge, Louisiana 70808
United States
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana 70808
United States
Johns Hopkins Univ/Sidney Kimmel Cancer Center
Baltimore, Maryland 21205
United States
Dana-Farber/Harvard Cancer Center
Boston, Massachusetts 02215
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109
United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
Siteman Cancer Center-West County
Creve Coeur, Missouri 63141
United States
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri 63110
United States
Siteman Cancer Center-South Country
St Louis, Missouri 63129
United States
Nebraska Medicine-Bellevue
Bellevue, Nebraska 68123
United States
Nebraska Medicine-Bellevue
Omaha, Nebraska 68118
United States
University of Nebraska Medical Center
Omaha, Nebraska 68198
United States
Renown Regional Medical Center
Reno, Nevada 89502
United States
Dartmouth Hitchcock Med Ctr/Dartmouth Cancer Ctr
Lebanon, New Hampshire 03756
United States
Cooper Hospital University Medical Center
Camden, New Jersey 08103
United States
HMH-Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
Jersey Shore University Medical Center
Neptune City, New Jersey 07753
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
United States
John Theurer Cancer Center at From Road
Paramus, New Jersey 07652
United States
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York 11042
United States
North Shore University Hospital
Manhasset, New York 11030
United States
NYU Langone Hospital - Long Island
Mineola, New York 11501
United States
Long Island Jewish Medical Center
New Hyde Park, New York 11040
United States
Laura and Issac Perlmutter Ca Ctr at NYU Langone
New York, New York 10016
United States
University of Rochester
Rochester, New York 14642
United States
Stony Brook University Medical Center
Stony Brook, New York 11794
United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina 28203
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
United States
Sanford Broadway Medical Center
Fargo, North Dakota 58122
United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Oregon Health and Science University
Portland, Oregon 97239
United States
Saint Vincent Hospital
Erie, Pennsylvania 16544
United States
Jefferson Hospital
Jefferson Hills, Pennsylvania 15025
United States
Forbes Hospital
Monroeville, Pennsylvania 15146
United States
Allegheny Valley Hospital
Natrona Heights, Pennsylvania 15065
United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania 19104
United States
Pennsylvania Hospital
Philadelphia, Pennsylvania 19107
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United States
West Penn Hospital
Pittsburgh, Pennsylvania 15224
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
Wexford Health and Wellness Pavilion
Wexford, Pennsylvania 15090
United States
Rhode Island Hospital
Providence, Rhode Island 02903
United States
Smilow Cancer Hospital Care Center - Westerly
Westerly, Rhode Island 02891
United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117
United States
University of Tennessee - Knoxville
Knoxville, Tennessee 37920
United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
United States
M D Anderson Cancer Center
Houston, Texas 77030
United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84132
United States
University of Vermont Medical Center
Burlington, Vermont 05401
United States
Vermont Regional Cancer Center
Burlington, Vermont 05405
United States
VCU Massey Cancer Center at Hanover Medical Park
Mechanicsville, Virginia 23116
United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia 23235
United States
Virginia Commonwealth Univ/Massey Cancer Center
Richmond, Virginia 23298
United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia 24014
United States
VCU Community Memorial Health Center
South Hill, Virginia 23970
United States
FHCC South Lake Union
Seattle, Washington 98109
United States
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United States
University of Washington Medical Center - Montlake
Seattle, Washington 98195
United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
United States
Marshfield Medical Center
Marshfield, Wisconsin 54449
United States
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Marshfield Medical Center
Minocqua, Wisconsin 54548
United States
Marshfield Medical Center
Rice Lake, Wisconsin 54868
United States
Marshfield Med Ctr-River Region at Stevens Point
Stevens Point, Wisconsin 54482
United States
Marshfield Medical Center
Weston, Wisconsin 54476
United States
Princess Alexandra Hospital - University Of Queensland
Woolloongabba, Queensland QLD 4102
Australia
Peter Maccallum Cancer Institute
Melbourne, Victoria 3000
Australia
Chris O'Brian Life House - Chris O'Brien Lifehouse
Camperdown, 2050
Australia
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia V5Z 4E6
Canada
London Regional Cancer Center
London, Ontario N6A 4L6
Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario
Canada
Hopital Maisonneuve Rosemont
Montreal, Quebec H1T 2M4
Canada
The Research Institute of the McGill University Health Centre
Montreal, Quebec H4A3J1
Canada
Mount Sinai Hospital
Toronto,
Canada
Bank Of Cyprus Oncology Centre
Stróvolos, 2006
Cyprus
Masaryk Memorial Cancer Institute
Brno, 656 53
Czechia
University Hospital Motol
Prague, 150 06
Czechia
Herlev Hospital - University Copenhagen
Herlev, Copenhagen 2730
Denmark
Aarhus University Hospitals - Aarhus University Hospital-Skejby
Aarhus, 8250
Denmark
Centre Leon Berard
Lyon, 69008
France
Institut du Cancer de Montpellier
Montpellier, 34298
France
Institut Curie- Hopital de Paris
Paris, 75248
France
Hopitaux Universitaires de Strasbourg - Hautepierre
Strasbourg, 67098
France
Institut Gustave Roussy
Villejuif, 94805
France
Universitaetsmedizin Goettingen - Georg-August Universitaet
Goettigen, Lower Saxony 37075
Germany
Universitaetsklinikum Carl Gustav Carus
Dresden, 01307
Germany
UniversitaetsMedizin Mannheim
Mannheim, 68167
Germany
Centro Di Riferimento Oncologico
Aviano, 33081
Italy
IRCCS - Fondazione Piemonte Inst di Candiolo
Candiolo,
Italy
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola,
Italy
IRCCS - Istituto Nazionale dei Tumori
Milan, 20133
Italy
Istituto Clinico Humanitas
Milan,
Italy
Istituto Europeo di Oncologia
Milan,
Italy
IRCCS - Istituto Oncologico Veneto
Padova,
Italy
Policlinico Universitario Campus Bio-Medico- Oncology Center
Roma,
Italy
Kyushu University Hospital
Higashiku, Fukuoka 812-8582
Japan
Yokohama City University Hospital
Yokohama, Kanagawa 236-0004
Japan
Kanagawa Cancer Center
Yokohama, Kanagawa 241-8515
Japan
Tohoku University Hospital
Sendai, Miyagi 780-8574
Japan
Aichi Cancer Center
Chikusa-ku, Nagoya 464-8681
Japan
Nagoya University Hospital
Shōwaku, Nagoya 466-8550
Japan
Niigata University Medical and Dental Hospital
Niigata, Niigata 951-8520
Japan
Okayama University Hospital
Kita-ku, Okayama-ken 700-8558
Japan
Osaka International Cancer Institute
Chuo-ku, Osaka 541-8567
Japan
National Cancer Center Hospital
Chuo-ku, Tokyo 104-0045
Japan
Cancer Institute Hospital of JFCR
Koto-ku, Tokyo 135-8550
Japan
Saitama Medical Center, Jichi Medical University
Saitama, 330-8503
Japan
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
Amsterdam, 1066
Netherlands
Leiden University Medical Centre
Leiden, 2300 RC
Netherlands
Radboudumc - Radboud University Medical Center Nijmegen
Nijmegen, 6525
Netherlands
Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw,
Poland
National Cancer Institute
Bratislava, SK 833 10
Slovakia
Hospital De La Santa Creu I Sant Pau
Barcelona, 08041
Spain
Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol
Barcelona,
Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007
Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
Spain
Hospital Universitario San Carlos
Madrid, 28040
Spain
University Hospitals Birmingham - Queen Elisabeth Medical Centre
Birmingham, B15 2TH
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, LS9 7TF
United Kingdom
the Royal Marsden Hospital
London,
United Kingdom
Clatterbridge cancer center
Metropolitan Borough of Wirral, CH63 4JY
United Kingdom
Newcastle Hospitals - Freeman Hospital, Northern Centre For Cancer Care
Newcastle, NE7 7DN
United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital
Nottingham, NG5 1PB
United Kingdom
Oxford University Hospitals NHS Trust - Churchill Hospital
Oxford, OX3 7LE
United Kingdom