Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma (STRASS2)

A Randomized Phase III Study of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery Alone for Patients With High Risk RetroPeritoneal Sarcoma (RPS)

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.

Study Overview

• Status: Recruiting
• Conditions: Leiomyosarcoma; Liposarcoma; Retroperitoneal Sarcoma
• Intervention / Treatment: Procedure: Surgery; Drug: Preoperative chemotherapy

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

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: EORTC HQ; Phone Number: +3227741611; Email: 1809@eortc.org

Study Locations

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    • Withdrawn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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

1. STRASS 2

   Inclusion Criteria:

   • Histologically proven primary high risk leiomyosarcoma (LMS) or Liposarcoma (LPS) of retroperitoneal space or infra-peritoneal spaces of pelvis.

   • LMS:

     • Any grade LMS can be included
     • Minimum size of LMS tumor should be 5 cm

   • LPS:

     • Diagnosis should be confirmed based on MDM2 (Mouse double minute 2 homolog) and CDK4 (Cyclin-dependent kinase 4) expression on IHC (immunohistochemistry), while proof of MDM2 amplification is highly recommended.
     • All grade 3 DDLPS can be included.

     • DDLPS with confirmed grade 2 on biopsy can be included when:

       • The grade 2 DDLPS has an FNCLCC score=5 (Fédération Nationale des Centres de Lutte Contre Le Cancer), and clear necrosis on imaging (whether or not present on the biopsy).
       • The tumors carry a high risk gene profile as determined by the Complexity INdex in SARComas (CINSARC-high)
     • Unifocal tumour
     • Resectable tumour: resectability is based on pre-operative imaging (CT-abdomen, potentially also with MRI) and has to be defined by the local treating sarcoma team. A patient is not considered resectable when the expectation is that only an R2 resection is feasible.
     • Criteria for non-resectability are:
     • Involvement of the superior mesenteric artery, aorta, coeliac trunk and/or portal vein
     • Involvement of bone
     • Growth into the spinal canal
     • Progression of retro-hepatic inferior vena cava leiomyosarcoma towards the right atrium
     • Infiltration of multiple major organs like liver, pancreas and or major vessels
     • Patient must have radiologically measurable disease (RECIST 1.1), as confirmed by imaging. CT thorax abdomen pelvis with IV contrast is the preferred imaging modality. In case of any contra-indications (medical or regulatory), it is allowed to perform a non-contrast CT thorax + MRI abdomen & pelvis
     • Collection of tumour tissue for central pathology review is mandatory.
     • For patients with LMS: if there is not enough tissue for assessing the grading, this is acceptable.
     • If tumour tissue is not available for the central pathology review, patient will not be eligible.
     • If the biopsy was not done or the FFPE of the biopsy not available but at least 10 unstained slides or one pathological block are available for the central review, that will be considered as acceptable.
     • For the biopsy if fine needle aspiration (FNA) is performed instead of core needle biopsy (CNB) recommended by the standard guidelines, please contact the EORTC medical monitors for further evaluation.
     • Collection of tumour tissue and blood samples for translational research is mandatory.
     • In case there is not enough tissue for TR, a new biopsy is not required and if the patient fulfils all other eligibility criteria, he/she will be eligible.
     • If the blood samples are not collected, patient will not be eligible.
     • If the patient refuses the collection of biomaterial for TR, patient will not be eligible even if he/she fulfils all other eligibility criteria
     • ≥ 18 years old (no upper age limit)
     • WHO performance status ≤ 2
     • Adequate haematological and organ function
     • American Society of Anaesthesiologist (ASA) score < 3
     • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 3 days prior to randomization.

   Note: a woman is considered of childbearing potential, i.e., fertile, if she is following menarche. She remains of childbearing potential until she becomes post-menopausal or permanently sterile.Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.

   A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 consecutive months without menses, a single FSH measurement is insufficient.

   • WOCBP in both arms should use highly effective birth control measures, during the study treatment period and for at least 6 months after the last dose of chemotherapy or date of surgery (except for women receiving chemotherapy with ifosfamide who should continue contraception until 1 year after last day of treatment). A highly effective method of birth control is defined as a method which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly.
   • For men in the experimental arm: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm.
   • Female subjects who are breast feeding should discontinue nursing prior to the first day of study treatment and until 6months after the last study treatment.
   • Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.

   Exclusion criteria:

   • Sarcoma originating from bone structure, abdominal or gynecological viscera
   • Extension through the sciatic notch or across the diaphragm
   • Metastatic disease
   • Any previous surgery (excluding diagnostic biopsy), radiotherapy or systemic therapy for the present tumour
   • Hypersensitivity to doxorubicin, ifosfamide, dacarbazine or to any of their metabolites or to any of their excipients
   • Congestive heart failure
   • Angina pectoris
   • Myocardial infarction within 1 year before randomization
   • Uncontrolled arterial hypertension defined as blood pressure ≥ 150/100 mm Hg despite optimal medical therapy.

   Note: in case of high blood pressure: 1) initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry; 2) blood pressure must be re-assessed on two occasions that are separated by a minimum of 1 hour. The mean SBP / DBP values from each blood pressure assessment must be ≤ 150/90mmHg in order for a patient to be eligible for the study.

   • Uncontrolled cardiac arrhythmia
   • Previous treatment with maximum cumulative doses (450mg/m² Doxorubicin or equivalent 900mg/m² Epirubicin) of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones
   • Active and uncontrolled infections
   • Vaccination with live vaccines within 30 days prior to study entry
   • Inflammation of the urinary bladder (interstitial cystitis) and/or obstructions of the urine flow.
   • Other invasive malignancy within 5 years, with the exception of adequately treated non-melanoma skin cancer, localized cervical cancer, localized and Gleason ≤ 6prostate cancer.
   • Uncontrolled severe illness, infection, medical condition (including uncontrolled diabetes), other than the primary LPS or LMS of the retroperitoneum.
   • Female patients who are pregnant or breastfeeding or female and male patients of reproductive potential who are not willing to employ effective birth control method.
   • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial
   • Known contraindication to imaging tracer and to MRI

2. Selection criteria for STREXIT 2

   • Patients with histologically proven primary resectable localized high-risk DDLPS or LMS of retroperitoneal space or infra-peritoneal spaces of pelvis (as described in the inclusion criteria of STRASS 2) and amenable to receive chemotherapy but for whom the list of eligibility criteria for the study is too restrictive (tumour grading not available, inadequate organ function, concomitant diseases)
   • Patients who meet all eligibility criteria of STRASS 2 but do not consent to randomization or are not enrolled for any other reason.
   • Patients enrolled in a Registry collecting data on primary RPS patients in the centres participating in STRASS 2 (e.g., RESAR) and who satisfy the above criteria.
3. Selection criteria for preferences for neoadjuvant chemotherapy in STRASS 2 substudy

All patients recruited to STRASS 2 in participating centres (Australia +/- international sites) that are able to read, comprehend and write in English at a sufficient level to complete study materials.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard arm; Surgery alone	Procedure: Surgery; Large en-bloc curative-intent surgery
Experimental: Experimental arm; Preoperative chemotherapy and surgery	Drug: Preoperative chemotherapy; High grade LPS: ADM 75 mg/m2 (or the equivalent EpiADM 120 mg/m2) + ifosfamide 9 g/m2 Q3 weeks; LMS: ADM 75 mg/m2 + DTIC 1g/m2 Q3 weeks Note: the recommended dose of Doxorubicin (or Epirubicin) can be modified according to national/institutional guidelines, given that the minimal threshold must be Doxorubicin 60 mg/m2 per cycle (or the equivalent Epirubicin 95 mg/m2 per cycle); the recommended dose of Ifosfamide can be modified according to national/institutional guidelines, given that the minimal threshold must be 7.5 g/m2 per cycle; the recommended dose of Dacarbazine can be modified according to national/institutional guidelines, given that the minimal threshold must be 900 mg/m2 per cycle. The schedule of administration of above chemotherapies can be modified according to national/institutional guidelines provided that the minimal threshold of doses, and the treatment periods with chemotherapies remain the same.; Other Names: neoadjuvant chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease free survival	Disease free survival will be measured from the date of randomization (as reference) to the date of recurrence or death, whichever occurs first.	7 years from first patient in

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	OS will be measured from the date of randomization to the date of death, whatever the cause. Alive patients will be censored at the date of last follow-up.	8 years from first patient in
Recurrence free survival	Recurrence free survival will be measured in patients who were successfully operated (R0/R1 resection) from the date of surgery (as reference) to the date of recurrence (local or distant) or death, whichever occurs first. Patients without one of these events will be censored at the date of last follow-up.	8 years from first patient in
Distant metastases free survival	Distant metastases free survival will be from the date of randomization (as reference) to the date of distant metastases or death (whatever the cause), whichever occurs first. Patients without any of these events will be censored at the date of last follow-up.	8 years from first patient in
Cumulative incidence of local recurrences	Cumulative incidence of local recurrences will be measured from the date of randomization (as reference) to the date of local recurrence.	8 years from first patient in
Cumulative incidence of distant metastases	Cumulative incidence of distant metastases will be measured from the date of randomization to the date of occurrence of distant metastases.	8 years from first patient in
Radiological response to neoadjuvant chemotherapy according to RECIST	For patients receiving neo-adjuvant chemotherapy, the radiological response will be assessed using RECIST 1.1 by comparison of the baseline and preoperative imaging.	8 years from first patient in
Radiological response to neoadjuvant chemotherapy according to CHOI	For patients receiving neo-adjuvant chemotherapy, the radiological response will be also assessed using Choi criteria by comparison of the baseline and preoperative imaging.	8 years from first patient in
Pathological response	Response evaluation will be done according to the EORTC response score.	8 years from first patient in
Safety and toxicity of neoadjuvant chemotherapy	Safety and toxicity of neoadjuvant chemotherapy will be evaluated and graded using CTCAE V5.0.	8 years from first patient in
Perioperative complications	Perioperative complications will be evaluated with the Dindo scale for the events related to the surgery and CTCAE V5.0 will be used for all other events.	8 years from first patient in
Late complications	Late complications (after the 60th day following the surgery) will be evaluated and graded according to the CTCAE version 5.0.	8 years from first patient in
Health-Related Quality of life (EORTC QLQ-C30 + Item list from QLQ-STO22)	Health-Related Quality of life assessment will be based on the EORTC QLQ C30 questionnaire version 3.0, with additional questions from the QLQ-STO22 module.	8 years from first patient in
Health utility, calculated from the collected patient-reported HRQoL data and patient demographics economics.	he EORTC QLQ C30 data will be mapped to health utility values using an established indirect mapping approach.	8 years from first patient in

Collaborators and Investigators

• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Collaborators: Canadian Cancer Trials Group; ECOG-ACRIN Cancer Research Group; Japan Clinical Oncology Group; Anticancer Fund, Belgium; Australia and New Zealand Sarcoma Association
• Investigators: Study Chair: Alessandro Gronchi, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano; Study Chair: Winan van Houdt, The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2021
• Primary Completion (Estimated): April 21, 2027
• Study Completion (Estimated): April 21, 2028

Study Registration Dates

• First Submitted: July 22, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 24, 2019

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms, Muscle Tissue; Neoplasms, Adipose Tissue; Leiomyosarcoma; Liposarcoma; Therapeutics; Combined Modality Therapy; Surgical Procedures, Operative; Neoadjuvant Therapy
• Other Study ID Numbers: EORTC 1809-STBSG; EA7211 (Other Identifier: ECOG-ACRIN Cancer Research Group); SR.7 (Other Identifier: Canadian Cancer Trials Group); ASSG45 (Other Identifier: Australia and New Zealand Sarcoma Association); JCOG2214INT (Other Identifier: Japan Clinical Oncology Group)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No