Actively Recruiting
A Randomized Study of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery Alone for Patients With High Risk Retroperitoneal Sarcoma
Led by European Organisation for Research and Treatment of Cancer - EORTC · Updated on 2026-05-22
250
Participants Needed
169
Research Sites
52 weeks
Total Duration
On this page
Sponsors
E
European Organisation for Research and Treatment of Cancer - EORTC
Lead Sponsor
C
Canadian Cancer Trials Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding chemotherapy before surgery can improve outcomes for patients with high-risk dedifferentiated liposarcoma (DDLPS) and leiomyosarcoma (LMS) in the retroperitoneal area. This phase III trial compares standard surgery alone to surgery combined with chemotherapy, aiming to improve disease-free survival for these patients. The study is randomized and open-label, involving multiple centers. Participants are randomly assigned to one of two groups. The standard group undergoes large curative surgery within four weeks after randomization. The experimental group receives three cycles of chemotherapy tailored to their sarcoma type—doxorubicin and ifosfamide for high-grade liposarcoma, or doxorubicin and dacarbazine for leiomyosarcoma—starting within two weeks of randomization, followed by a reassessment and surgery within three to six weeks after the last chemotherapy cycle. During the study, patients are closely monitored through imaging and pathology reviews to confirm tumor characteristics and treatment effects. Researchers measure disease-free survival over seven years, along with overall survival, recurrence rates, response to chemotherapy, side effects, complications, and quality of life for up to eight years. Participants provide tumor tissue and blood samples for research, and their health and safety are carefully tracked throughout the study period.
CONDITIONS
Brief Title
Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed primary high risk leiomyosarcoma (any grade, tumor size 5 cm) or dedifferentiated liposarcoma of the retroperitoneal or pelvic area
- Liposarcoma diagnosis confirmed by MDM2 and CDK4 expression, with recommended MDM2 amplification proof
- Grade 3 dedifferentiated liposarcoma or certain grade 2 cases with high-risk features
- Unifocal and surgically resectable tumor based on imaging
- Radiologically measurable disease confirmed by CT or MRI
- Mandatory tumor tissue collection for pathology and translational research
- Age 18 years or older with no upper age limit
- WHO performance status 2
- Adequate blood and organ function
- ASA score less than 3
- Women of childbearing potential must have negative pregnancy test and use effective contraception
- Men in experimental arm must agree to contraception and abstain from sperm donation
- Written informed consent provided according to regulations
You will not qualify if you...
- Sarcoma originating from bone or abdominal/gynecological organs
- Tumor extension through sciatic notch or diaphragm
- Metastatic disease
- Previous surgery (except biopsy), radiotherapy, or systemic therapy for the current tumor
- Allergy to doxorubicin, ifosfamide, dacarbazine, or their components
- Heart conditions including congestive heart failure, angina, or recent myocardial infarction
- Uncontrolled high blood pressure or cardiac arrhythmia
- Prior high cumulative doses of certain chemotherapy drugs
- Active uncontrolled infections
- Recent live vaccinations
- Urinary bladder inflammation or urinary flow obstruction
- Other invasive cancers within 5 years except certain treated skin or localized cancers
- Uncontrolled severe illness or medical conditions besides the primary tumor
- Pregnancy, breastfeeding, or unwillingness to use effective contraception
- Psychological or social conditions that may interfere with study compliance
- Known contraindications to imaging tracers or MRI scans
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 9 weeks (3 cycles every 3 weeks)
Participants in the experimental arm receive 3 cycles of chemotherapy with drugs such as doxorubicin, ifosfamide or dacarbazine before surgery.
3 chemotherapy visits every 3 weeks
Duration - Within 4 weeks following randomization for standard arm; within 3-6 weeks after chemotherapy for experimental arm
Participants undergo large en-bloc curative-intent surgery to remove the tumor.
1 surgery visit (in-person)
Trial Site Locations
Total: 169 locations
1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
Withdrawn
2
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States, 85054
Actively Recruiting
3
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
4
UCI Health-Chao Family Comp CC and Ambulatory Care
Irvine, California, United States, 92612
Actively Recruiting
5
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
6
UC Irvine Health/Chao Family Comprehensive Ca Ctr
Orange, California, United States, 92668
Actively Recruiting
7
UCHealth University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
8
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, United States, 06418
Actively Recruiting
9
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, United States, 06824
Actively Recruiting
10
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, United States, 06033
Actively Recruiting
11
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, United States, 06830
Actively Recruiting
12
Smilow Cancer Hospital Care Center - Guiford
Guilford, Connecticut, United States, 06437
Actively Recruiting
13
Smilow Cancer Hospital Care Ctr at Saint Francis
Hartford, Connecticut, United States, 06105
Actively Recruiting
14
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
15
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, United States, 06385
Actively Recruiting
16
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, United States, 06902
Actively Recruiting
17
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States, 06611
Actively Recruiting
18
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, United States, 06708
Actively Recruiting
19
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, United States, 06385
Actively Recruiting
20
Univ of Florida Health Science Ctr - Gainesville
Gainesville, Florida, United States, 32610
Actively Recruiting
21
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
22
Moffitt Cancer Center-International Plaza
Tampa, Florida, United States, 33607
Actively Recruiting
23
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, United States, 33612
Actively Recruiting
24
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
25
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
26
Northwestern University
Chicago, Illinois, United States, 60611
Withdrawn
27
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
28
University of Illinois at Chicago MBCCOP
Chicago, Illinois, United States, 60612
Actively Recruiting
29
Indiana Univ/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Withdrawn
30
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
31
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States, 66210
Actively Recruiting
32
University of Kansas Hospital-Westwood Cancer Ctr
Westwood, Kansas, United States, 66205
Actively Recruiting
33
James Graham Brown Ca Ctr at Univ of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
34
UofL Health Medical Center Northeast
Louisville, Kentucky, United States, 40245
Actively Recruiting
35
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, United States, 70805
Actively Recruiting
36
Our Lady of The Lake Hospital
Baton Rouge, Louisiana, United States, 70808
Actively Recruiting
37
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, United States, 70808
Actively Recruiting
38
Johns Hopkins Univ/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21205
Withdrawn
39
Dana-Farber/Harvard Cancer Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
40
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
41
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States, 56601
Actively Recruiting
42
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
43
Siteman Cancer Center-West County
Creve Coeur, Missouri, United States, 63141
Actively Recruiting
44
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States, 63110
Actively Recruiting
45
Siteman Cancer Center-South Country
St Louis, Missouri, United States, 63129
Actively Recruiting
46
Nebraska Medicine-Bellevue
Bellevue, Nebraska, United States, 68123
Actively Recruiting
47
Nebraska Medicine-Bellevue
Omaha, Nebraska, United States, 68118
Actively Recruiting
48
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
49
Renown Regional Medical Center
Reno, Nevada, United States, 89502
Actively Recruiting
50
Dartmouth Hitchcock Med Ctr/Dartmouth Cancer Ctr
Lebanon, New Hampshire, United States, 03756
Withdrawn
51
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
Actively Recruiting
52
HMH-Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
53
Jersey Shore University Medical Center
Neptune City, New Jersey, United States, 07753
Actively Recruiting
54
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
55
John Theurer Cancer Center at From Road
Paramus, New Jersey, United States, 07652
Actively Recruiting
56
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
57
Northwell Health/Center for Advanced Medicine
Lake Success, New York, United States, 11042
Actively Recruiting
58
North Shore University Hospital
Manhasset, New York, United States, 11030
Actively Recruiting
59
NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
60
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Actively Recruiting
61
Laura and Issac Perlmutter Ca Ctr at NYU Langone
New York, New York, United States, 10016
Actively Recruiting
62
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
63
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
Actively Recruiting
64
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Actively Recruiting
65
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
66
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States, 58501
Withdrawn
67
Sanford Broadway Medical Center
Fargo, North Dakota, United States, 58122
Withdrawn
68
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
Withdrawn
69
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
70
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
71
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
72
Saint Vincent Hospital
Erie, Pennsylvania, United States, 16544
Actively Recruiting
73
Jefferson Hospital
Jefferson Hills, Pennsylvania, United States, 15025
Actively Recruiting
74
Forbes Hospital
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
75
Allegheny Valley Hospital
Natrona Heights, Pennsylvania, United States, 15065
Actively Recruiting
76
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
77
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
78
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
79
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
80
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
81
West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
82
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
83
Wexford Health and Wellness Pavilion
Wexford, Pennsylvania, United States, 15090
Actively Recruiting
84
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
85
Smilow Cancer Hospital Care Center - Westerly
Westerly, Rhode Island, United States, 02891
Actively Recruiting
86
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
Withdrawn
87
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117
Withdrawn
88
University of Tennessee - Knoxville
Knoxville, Tennessee, United States, 37920
Actively Recruiting
89
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
90
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Actively Recruiting
91
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
92
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84132
Actively Recruiting
93
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Actively Recruiting
94
Vermont Regional Cancer Center
Burlington, Vermont, United States, 05405
Actively Recruiting
95
VCU Massey Cancer Center at Hanover Medical Park
Mechanicsville, Virginia, United States, 23116
Actively Recruiting
96
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, United States, 23235
Actively Recruiting
97
Virginia Commonwealth Univ/Massey Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
98
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States, 24014
Actively Recruiting
99
VCU Community Memorial Health Center
South Hill, Virginia, United States, 23970
Withdrawn
100
FHCC South Lake Union
Seattle, Washington, United States, 98109
Withdrawn
101
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
102
University of Washington Medical Center - Montlake
Seattle, Washington, United States, 98195
Actively Recruiting
103
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, United States, 54701
Actively Recruiting
104
Marshfield Medical Center
Marshfield, Wisconsin, United States, 54449
Actively Recruiting
105
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
106
Marshfield Medical Center
Minocqua, Wisconsin, United States, 54548
Actively Recruiting
107
Marshfield Medical Center
Rice Lake, Wisconsin, United States, 54868
Actively Recruiting
108
Marshfield Med Ctr-River Region at Stevens Point
Stevens Point, Wisconsin, United States, 54482
Actively Recruiting
109
Marshfield Medical Center
Weston, Wisconsin, United States, 54476
Actively Recruiting
110
Princess Alexandra Hospital - University Of Queensland
Woolloongabba, Queensland, Australia, QLD 4102
Actively Recruiting
111
Peter Maccallum Cancer Institute
Melbourne, Victoria, Australia, 3000
Actively Recruiting
112
Chris O'Brian Life House - Chris O'Brien Lifehouse
Camperdown, Australia, 2050
Actively Recruiting
113
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
114
London Regional Cancer Center
London, Ontario, Canada, N6A 4L6
Actively Recruiting
115
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
Actively Recruiting
116
Hopital Maisonneuve Rosemont
Montreal, Quebec, Canada, H1T 2M4
Actively Recruiting
117
The Research Institute of the McGill University Health Centre
Montreal, Quebec, Canada, H4A3J1
Actively Recruiting
118
Mount Sinai Hospital
Toronto, Canada
Actively Recruiting
119
Bank Of Cyprus Oncology Centre
Stróvolos, Cyprus, 2006
Withdrawn
120
Masaryk Memorial Cancer Institute
Brno, Czechia, 656 53
Actively Recruiting
121
University Hospital Motol
Prague, Czechia, 150 06
Not Yet Recruiting
122
Herlev Hospital - University Copenhagen
Herlev, Copenhagen, Denmark, 2730
Actively Recruiting
123
Aarhus University Hospitals - Aarhus University Hospital-Skejby
Aarhus, Denmark, 8250
Actively Recruiting
124
Centre Leon Berard
Lyon, France, 69008
Actively Recruiting
125
Institut du Cancer de Montpellier
Montpellier, France, 34298
Withdrawn
126
Institut Curie- Hopital de Paris
Paris, France, 75248
Actively Recruiting
127
Hopitaux Universitaires de Strasbourg - Hautepierre
Strasbourg, France, 67098
Withdrawn
128
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
129
Universitaetsmedizin Goettingen - Georg-August Universitaet
Goettigen, Lower Saxony, Germany, 37075
Actively Recruiting
130
Universitaetsklinikum Carl Gustav Carus
Dresden, Germany, 01307
Withdrawn
131
UniversitaetsMedizin Mannheim
Mannheim, Germany, 68167
Actively Recruiting
132
Centro Di Riferimento Oncologico
Aviano, Italy, 33081
Withdrawn
133
IRCCS - Fondazione Piemonte Inst di Candiolo
Candiolo, Italy
Actively Recruiting
134
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, Italy
Actively Recruiting
135
IRCCS - Istituto Nazionale dei Tumori
Milan, Italy, 20133
Actively Recruiting
136
Istituto Clinico Humanitas
Milan, Italy
Actively Recruiting
137
Istituto Europeo di Oncologia
Milan, Italy
Actively Recruiting
138
IRCCS - Istituto Oncologico Veneto
Padova, Italy
Actively Recruiting
139
Policlinico Universitario Campus Bio-Medico- Oncology Center
Roma, Italy
Actively Recruiting
140
Kyushu University Hospital
Higashiku, Fukuoka, Japan, 812-8582
Actively Recruiting
141
Yokohama City University Hospital
Yokohama, Kanagawa, Japan, 236-0004
Actively Recruiting
142
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan, 241-8515
Actively Recruiting
143
Tohoku University Hospital
Sendai, Miyagi, Japan, 780-8574
Actively Recruiting
144
Aichi Cancer Center
Chikusa-ku, Nagoya, Japan, 464-8681
Actively Recruiting
145
Nagoya University Hospital
Shōwaku, Nagoya, Japan, 466-8550
Actively Recruiting
146
Niigata University Medical and Dental Hospital
Niigata, Niigata, Japan, 951-8520
Actively Recruiting
147
Okayama University Hospital
Kita-ku, Okayama-ken, Japan, 700-8558
Actively Recruiting
148
Osaka International Cancer Institute
Chuo-ku, Osaka, Japan, 541-8567
Actively Recruiting
149
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
Actively Recruiting
150
Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan, 135-8550
Actively Recruiting
151
Saitama Medical Center, Jichi Medical University
Saitama, Japan, 330-8503
Actively Recruiting
152
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
Amsterdam, Netherlands, 1066
Actively Recruiting
153
Leiden University Medical Centre
Leiden, Netherlands, 2300 RC
Actively Recruiting
154
Radboudumc - Radboud University Medical Center Nijmegen
Nijmegen, Netherlands, 6525
Actively Recruiting
155
Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, Poland
Actively Recruiting
156
National Cancer Institute
Bratislava, Slovakia, SK 833 10
Actively Recruiting
157
Hospital De La Santa Creu I Sant Pau
Barcelona, Spain, 08041
Actively Recruiting
158
Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol
Barcelona, Spain
Actively Recruiting
159
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007
Actively Recruiting
160
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain, 28040
Not Yet Recruiting
161
Hospital Universitario San Carlos
Madrid, Spain, 28040
Actively Recruiting
162
University Hospitals Birmingham - Queen Elisabeth Medical Centre
Birmingham, United Kingdom, B15 2TH
Actively Recruiting
163
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital
Glasgow, United Kingdom
Withdrawn
164
Leeds Teaching Hospitals NHS Trust - St. James's University Hospital
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
165
the Royal Marsden Hospital
London, United Kingdom
Actively Recruiting
166
Clatterbridge cancer center
Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
Actively Recruiting
167
Newcastle Hospitals - Freeman Hospital, Northern Centre For Cancer Care
Newcastle, United Kingdom, NE7 7DN
Not Yet Recruiting
168
Nottingham University Hospitals NHS Trust - City Hospital
Nottingham, United Kingdom, NG5 1PB
Actively Recruiting
169
Oxford University Hospitals NHS Trust - Churchill Hospital
Oxford, United Kingdom, OX3 7LE
Withdrawn
Research Team
E
EORTC HQ
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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