Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT04031677

Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma

Led by European Organisation for Research and Treatment of Cancer - EORTC · Updated on 2026-03-31

250

Participants Needed

164

Research Sites

378 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

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.

CONDITIONS

Official Title

Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years or older
  • Histologically confirmed primary high-risk leiomyosarcoma or liposarcoma in the retroperitoneal or pelvic infra-peritoneal spaces
  • Leiomyosarcoma of any grade with tumor size at least 5 cm
  • Liposarcoma diagnosis confirmed by MDM2 and CDK4 expression; all grade 3 dedifferentiated liposarcoma included
  • Grade 2 dedifferentiated liposarcoma eligible if FNCLCC score is 5 with necrosis on imaging and high-risk gene profile (CINSARC-high)
  • Unifocal, resectable tumor based on imaging and surgical assessment
  • Measurable disease confirmed by imaging (CT thorax, abdomen, pelvis with contrast preferred)
  • Mandatory collection of tumor tissue for central pathology review and blood samples for research
  • WHO performance status 0 to 2
  • Adequate blood and organ function
  • American Society of Anaesthesiology score less than 3
  • Women of childbearing potential must have a negative pregnancy test within 3 days prior to randomization
  • Use of effective birth control during treatment and for recommended periods after treatment
  • Men in the experimental arm must agree to abstain or use contraception and refrain from sperm donation
  • Female breastfeeding patients must stop nursing before treatment and for 6 months afterwards
  • Written informed consent obtained according to regulations
Not Eligible

You will not qualify if you...

  • Sarcoma originating from bone, abdominal, or gynecological organs
  • Tumor extension through sciatic notch or diaphragm
  • Metastatic disease
  • Prior surgery (except biopsy), radiotherapy, or systemic therapy for this tumor
  • Allergy or hypersensitivity to study drugs or their components
  • Heart conditions including congestive heart failure, angina, myocardial infarction within last year, uncontrolled hypertension (blood pressure ≥150/100 mm Hg)
  • Uncontrolled cardiac arrhythmia
  • Previous maximum cumulative doses of anthracyclines reached
  • Active uncontrolled infections
  • Live vaccine within 30 days prior to study
  • Urinary bladder inflammation or obstruction
  • Other invasive cancers within past 5 years (exceptions apply)
  • Uncontrolled severe illness or medical condition other than the sarcoma
  • Pregnancy or breastfeeding
  • Patients unwilling to use effective birth control
  • Psychological, social, or geographic conditions that may interfere with study participation
  • Known contraindications to imaging tracer or MRI

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 164 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

NYU Langone Hospital - Long Island

Mineola, New York, United States, 11501

Actively Recruiting

58

Laura and Issac Perlmutter Ca Ctr at NYU Langone

New York, New York, United States, 10016

Actively Recruiting

59

University of Rochester

Rochester, New York, United States, 14642

Actively Recruiting

60

Stony Brook University Medical Center

Stony Brook, New York, United States, 11794

Actively Recruiting

61

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States, 28203

Actively Recruiting

62

Duke University Medical Center

Durham, North Carolina, United States, 27710

Actively Recruiting

63

Sanford Bismarck Medical Center

Bismarck, North Dakota, United States, 58501

Withdrawn

64

Sanford Broadway Medical Center

Fargo, North Dakota, United States, 58122

Withdrawn

65

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States, 58122

Withdrawn

66

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

Actively Recruiting

67

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

68

Oregon Health and Science University

Portland, Oregon, United States, 97239

Actively Recruiting

69

Saint Vincent Hospital

Erie, Pennsylvania, United States, 16544

Actively Recruiting

70

Jefferson Hospital

Jefferson Hills, Pennsylvania, United States, 15025

Actively Recruiting

71

Forbes Hospital

Monroeville, Pennsylvania, United States, 15146

Actively Recruiting

72

Allegheny Valley Hospital

Natrona Heights, Pennsylvania, United States, 15065

Actively Recruiting

73

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

74

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

75

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

76

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States, 19111

Actively Recruiting

77

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States, 15212

Actively Recruiting

78

West Penn Hospital

Pittsburgh, Pennsylvania, United States, 15224

Actively Recruiting

79

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232

Actively Recruiting

80

Wexford Health and Wellness Pavilion

Wexford, Pennsylvania, United States, 15090

Actively Recruiting

81

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

Actively Recruiting

82

Smilow Cancer Hospital Care Center - Westerly

Westerly, Rhode Island, United States, 02891

Actively Recruiting

83

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, United States, 57104

Withdrawn

84

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States, 57117

Withdrawn

85

University of Tennessee - Knoxville

Knoxville, Tennessee, United States, 37920

Actively Recruiting

86

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

87

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States, 75390

Actively Recruiting

88

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

89

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States, 84132

Actively Recruiting

90

University of Vermont Medical Center

Burlington, Vermont, United States, 05401

Actively Recruiting

91

Vermont Regional Cancer Center

Burlington, Vermont, United States, 05405

Actively Recruiting

92

VCU Massey Cancer Center at Hanover Medical Park

Mechanicsville, Virginia, United States, 23116

Actively Recruiting

93

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, United States, 23235

Actively Recruiting

94

Virginia Commonwealth Univ/Massey Cancer Center

Richmond, Virginia, United States, 23298

Actively Recruiting

95

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, United States, 24014

Actively Recruiting

96

VCU Community Memorial Health Center

South Hill, Virginia, United States, 23970

Withdrawn

97

FHCC South Lake Union

Seattle, Washington, United States, 98109

Withdrawn

98

Fred Hutchinson Cancer Center

Seattle, Washington, United States, 98109

Actively Recruiting

99

University of Washington Medical Center - Montlake

Seattle, Washington, United States, 98195

Actively Recruiting

100

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, United States, 54701

Actively Recruiting

101

Marshfield Medical Center

Marshfield, Wisconsin, United States, 54449

Actively Recruiting

102

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

103

Marshfield Medical Center

Minocqua, Wisconsin, United States, 54548

Actively Recruiting

104

Marshfield Medical Center

Rice Lake, Wisconsin, United States, 54868

Actively Recruiting

105

Marshfield Med Ctr-River Region at Stevens Point

Stevens Point, Wisconsin, United States, 54482

Actively Recruiting

106

Marshfield Medical Center

Weston, Wisconsin, United States, 54476

Actively Recruiting

107

Princess Alexandra Hospital - University Of Queensland

Woolloongabba, Queensland, Australia, QLD 4102

Actively Recruiting

108

Peter Maccallum Cancer Institute

Melbourne, Victoria, Australia, 3000

Actively Recruiting

109

Chris O'Brian Life House - Chris O'Brien Lifehouse

Camperdown, Australia, 2050

Actively Recruiting

110

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, Canada, V5Z 4E6

Actively Recruiting

111

London Regional Cancer Center

London, Ontario, Canada, N6A 4L6

Actively Recruiting

112

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

Actively Recruiting

113

Hopital Maisonneuve Rosemont

Montreal, Quebec, Canada, H1T 2M4

Actively Recruiting

114

The Research Institute of the McGill University Health Centre

Montreal, Quebec, Canada, H4A3J1

Actively Recruiting

115

Mount Sinai Hospital

Toronto, Canada

Actively Recruiting

116

Bank Of Cyprus Oncology Centre

Stróvolos, Cyprus, 2006

Withdrawn

117

Masaryk Memorial Cancer Institute

Brno, Czechia, 656 53

Actively Recruiting

118

Herlev Hospital - University Copenhagen

Herlev, Copenhagen, Denmark, 2730

Actively Recruiting

119

Aarhus University Hospitals - Aarhus University Hospital-Skejby

Aarhus, Denmark, 8250

Actively Recruiting

120

Centre Leon Berard

Lyon, France, 69008

Actively Recruiting

121

Institut du Cancer de Montpellier

Montpellier, France, 34298

Withdrawn

122

Institut Curie- Hopital de Paris

Paris, France, 75248

Actively Recruiting

123

Hopitaux Universitaires de Strasbourg - Hautepierre

Strasbourg, France, 67098

Withdrawn

124

Institut Gustave Roussy

Villejuif, France, 94805

Actively Recruiting

125

Universitaetsmedizin Goettingen - Georg-August Universitaet

Goettigen, Lower Saxony, Germany, 37075

Actively Recruiting

126

Universitaetsklinikum Carl Gustav Carus

Dresden, Germany, 01307

Withdrawn

127

UniversitaetsMedizin Mannheim

Mannheim, Germany, 68167

Actively Recruiting

128

Centro Di Riferimento Oncologico

Aviano, Italy, 33081

Withdrawn

129

IRCCS - Fondazione Piemonte Inst di Candiolo

Candiolo, Italy

Actively Recruiting

130

IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

Meldola, Italy

Actively Recruiting

131

IRCCS - Istituto Nazionale dei Tumori

Milan, Italy, 20133

Actively Recruiting

132

Istituto Clinico Humanitas

Milan, Italy

Actively Recruiting

133

Istituto Europeo di Oncologia

Milan, Italy

Actively Recruiting

134

IRCCS - Istituto Oncologico Veneto

Padova, Italy

Actively Recruiting

135

Policlinico Universitario Campus Bio-Medico- Oncology Center

Roma, Italy

Actively Recruiting

136

Kyushu University Hospital

Higashiku, Fukuoka, Japan, 812-8582

Actively Recruiting

137

Yokohama City University Hospital

Yokohama, Kanagawa, Japan, 236-0004

Actively Recruiting

138

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan, 241-8515

Actively Recruiting

139

Tohoku University Hospital

Sendai, Miyagi, Japan, 780-8574

Actively Recruiting

140

Aichi Cancer Center

Chikusa-ku, Nagoya, Japan, 464-8681

Actively Recruiting

141

Nagoya University Hospital

Shōwaku, Nagoya, Japan, 466-8550

Actively Recruiting

142

Niigata University Medical and Dental Hospital

Niigata, Niigata, Japan, 951-8520

Actively Recruiting

143

Okayama University Hospital

Kita-ku, Okayama-ken, Japan, 700-8558

Actively Recruiting

144

Osaka International Cancer Institute

Chuo-ku, Osaka, Japan, 541-8567

Actively Recruiting

145

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan, 104-0045

Actively Recruiting

146

Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan, 135-8550

Actively Recruiting

147

Saitama Medical Center, Jichi Medical University

Saitama, Japan, 330-8503

Actively Recruiting

148

The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

Amsterdam, Netherlands, 1066

Actively Recruiting

149

Leiden University Medical Centre

Leiden, Netherlands, 2300 RC

Actively Recruiting

150

Radboudumc - Radboud University Medical Center Nijmegen

Nijmegen, Netherlands, 6525

Actively Recruiting

151

Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology

Warsaw, Poland

Actively Recruiting

152

National Cancer Institute

Bratislava, Slovakia, SK 833 10

Actively Recruiting

153

Hospital De La Santa Creu I Sant Pau

Barcelona, Spain, 08041

Actively Recruiting

154

Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol

Barcelona, Spain

Actively Recruiting

155

Hospital General Universitario Gregorio Maranon

Madrid, Spain, 28007

Actively Recruiting

156

Hospital Universitario San Carlos

Madrid, Spain, 28040

Actively Recruiting

157

University Hospitals Birmingham - Queen Elisabeth Medical Centre

Birmingham, United Kingdom, B15 2TH

Actively Recruiting

158

NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital

Glasgow, United Kingdom

Withdrawn

159

Leeds Teaching Hospitals NHS Trust - St. James's University Hospital

Leeds, United Kingdom, LS9 7TF

Actively Recruiting

160

the Royal Marsden Hospital

London, United Kingdom

Actively Recruiting

161

Clatterbridge cancer center

Metropolitan Borough of Wirral, United Kingdom, CH63 4JY

Actively Recruiting

162

Newcastle Hospitals - Freeman Hospital, Northern Centre For Cancer Care

Newcastle, United Kingdom, NE7 7DN

Not Yet Recruiting

163

Nottingham University Hospitals NHS Trust - City Hospital

Nottingham, United Kingdom, NG5 1PB

Actively Recruiting

164

Oxford University Hospitals NHS Trust - Churchill Hospital

Oxford, United Kingdom, OX3 7LE

Withdrawn

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Research Team

E

EORTC HQ

CONTACT

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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Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma | DecenTrialz