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RECRUITING Phase 3 ClinicalTrials.gov

Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma

Sponsor: European Organisation for Research and Treatment of Cancer - EORTC • ClinicalTrials.gov ID: NCT04031677

Registry updated: 2026-10-07
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Description

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.

Interventions

  • Surgery (Procedure)
    Large en-bloc curative-intent surgery
  • Preoperative chemotherapy (Drug)
    * 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.

Eligibility criteria

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.

Conditions

Retroperitoneal Sarcoma Liposarcoma Leiomyosarcoma

Locations

  • University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
  • Mayo Clinic Hospital in Arizona — Phoenix, Arizona, United States
  • City of Hope Comprehensive Cancer Center — Duarte, California, United States
  • UCI Health-Chao Family Comp CC and Ambulatory Care — Irvine, California, United States
  • UC San Diego Moores Cancer Center — La Jolla, California, United States
  • UC Irvine Health/Chao Family Comprehensive Ca Ctr — Orange, California, United States
  • UCHealth University of Colorado Hospital — Aurora, Colorado, United States
  • Smilow Cancer Hospital-Derby Care Center — Derby, Connecticut, United States
  • Smilow Cancer Hospital Care Center-Fairfield — Fairfield, Connecticut, United States
  • Smilow Cancer Hospital Care Center at Glastonbury — Glastonbury, Connecticut, United States
  • Smilow Cancer Hospital Care Center at Greenwich — Greenwich, Connecticut, United States
  • Smilow Cancer Hospital Care Center - Guiford — Guilford, Connecticut, United States
  • Smilow Cancer Hospital Care Ctr at Saint Francis — Hartford, Connecticut, United States
  • Yale University — New Haven, Connecticut, United States
  • Yale-New Haven Hospital North Haven Medical Center — North Haven, Connecticut, United States
  • Smilow Cancer Hospital Care Center at Long Ridge — Stamford, Connecticut, United States
  • Smilow Cancer Hospital Care Center-Trumbull — Trumbull, Connecticut, United States
  • Smilow Cancer Hospital-Waterbury Care Center — Waterbury, Connecticut, United States
  • Smilow Cancer Hospital Care Center - Waterford — Waterford, Connecticut, United States
  • Univ of Florida Health Science Ctr - Gainesville — Gainesville, Florida, United States
  • Mayo Clinic in Florida — Jacksonville, Florida, United States
  • Moffitt Cancer Center-International Plaza — Tampa, Florida, United States
  • Moffitt Cancer Center - McKinley Campus — Tampa, Florida, United States
  • Moffitt Cancer Center — Tampa, Florida, United States
  • Emory University Hospital Midtown — Atlanta, Georgia, United States
  • Northwestern University — Chicago, Illinois, United States
  • Rush University Medical Center — Chicago, Illinois, United States
  • University of Illinois at Chicago MBCCOP — Chicago, Illinois, United States
  • Midwestern Regional Medical Center — Zion, Illinois, United States
  • Indiana Univ/Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
  • University of Kansas Cancer Center — Kansas City, Kansas, United States
  • University of Kansas Cancer Center-Overland Park — Overland Park, Kansas, United States
  • University of Kansas Hospital-Westwood Cancer Ctr — Westwood, Kansas, United States
  • James Graham Brown Ca Ctr at Univ of Louisville — Louisville, Kentucky, United States
  • UofL Health Medical Center Northeast — Louisville, Kentucky, United States
  • LSU Health Baton Rouge-North Clinic — Baton Rouge, Louisiana, United States
  • Our Lady of The Lake Hospital — Baton Rouge, Louisiana, United States
  • Our Lady of the Lake Physician Group — Baton Rouge, Louisiana, United States
  • Johns Hopkins Univ/Sidney Kimmel Cancer Center — Baltimore, Maryland, United States
  • Dana-Farber/Harvard Cancer Center — Boston, Massachusetts, United States
  • University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
  • Sanford Joe Lueken Cancer Center — Bemidji, Minnesota, United States
  • Mayo Clinic — Rochester, Minnesota, United States
  • Siteman Cancer Center-West County — Creve Coeur, Missouri, United States
  • Washington University School of Medicine - Siteman Cancer Center — St Louis, Missouri, United States
  • Siteman Cancer Center-South Country — St Louis, Missouri, United States
  • Nebraska Medicine-Bellevue — Bellevue, Nebraska, United States
  • Nebraska Medicine-Bellevue — Omaha, Nebraska, United States
  • University of Nebraska Medical Center — Omaha, Nebraska, United States
  • Renown Regional Medical Center — Reno, Nevada, United States
  • Dartmouth Hitchcock Med Ctr/Dartmouth Cancer Ctr — Lebanon, New Hampshire, United States
  • Cooper Hospital University Medical Center — Camden, New Jersey, United States
  • HMH-Hackensack University Medical Center — Hackensack, New Jersey, United States
  • Jersey Shore University Medical Center — Neptune City, New Jersey, United States
  • Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
  • John Theurer Cancer Center at From Road — Paramus, New Jersey, United States
  • Roswell Park Cancer Institute — Buffalo, New York, United States
  • Northwell Health/Center for Advanced Medicine — Lake Success, New York, United States
  • North Shore University Hospital — Manhasset, New York, United States
  • NYU Langone Hospital - Long Island — Mineola, New York, United States
  • Long Island Jewish Medical Center — New Hyde Park, New York, United States
  • Laura and Issac Perlmutter Ca Ctr at NYU Langone — New York, New York, United States
  • University of Rochester — Rochester, New York, United States
  • Stony Brook University Medical Center — Stony Brook, New York, United States
  • Montefiore Medical Center-Einstein Campus — The Bronx, New York, United States
  • Montefiore Medical Center - Moses Campus — The Bronx, New York, United States
  • Carolinas Medical Center/Levine Cancer Institute — Charlotte, North Carolina, United States
  • Duke University Medical Center — Durham, North Carolina, United States
  • Sanford Bismarck Medical Center — Bismarck, North Dakota, United States
  • Sanford Broadway Medical Center — Fargo, North Dakota, United States
  • Sanford Roger Maris Cancer Center — Fargo, North Dakota, United States
  • Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
  • University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
  • Oregon Health and Science University — Portland, Oregon, United States
  • Saint Vincent Hospital — Erie, Pennsylvania, United States
  • Jefferson Hospital — Jefferson Hills, Pennsylvania, United States
  • Forbes Hospital — Monroeville, Pennsylvania, United States
  • Allegheny Valley Hospital — Natrona Heights, Pennsylvania, United States
  • University of Pennsylvania/Abramson Cancer Center — Philadelphia, Pennsylvania, United States
  • Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
  • Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
  • Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
  • Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
  • West Penn Hospital — Pittsburgh, Pennsylvania, United States
  • UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
  • Wexford Health and Wellness Pavilion — Wexford, Pennsylvania, United States
  • Rhode Island Hospital — Providence, Rhode Island, United States
  • Smilow Cancer Hospital Care Center - Westerly — Westerly, Rhode Island, United States
  • Sanford Cancer Center Oncology Clinic — Sioux Falls, South Dakota, United States
  • Sanford USD Medical Center - Sioux Falls — Sioux Falls, South Dakota, United States
  • University of Tennessee - Knoxville — Knoxville, Tennessee, United States
  • Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States
  • UT Southwestern/Simmons Cancer Center-Dallas — Dallas, Texas, United States
  • M D Anderson Cancer Center — Houston, Texas, United States
  • Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah, United States
  • University of Vermont Medical Center — Burlington, Vermont, United States
  • Vermont Regional Cancer Center — Burlington, Vermont, United States
  • VCU Massey Cancer Center at Hanover Medical Park — Mechanicsville, Virginia, United States
  • VCU Massey Cancer Center at Stony Point — Richmond, Virginia, United States
  • Virginia Commonwealth Univ/Massey Cancer Center — Richmond, Virginia, United States
  • Carilion Roanoke Memorial Hospital — Roanoke, Virginia, United States
  • VCU Community Memorial Health Center — South Hill, Virginia, United States
  • FHCC South Lake Union — Seattle, Washington, United States
  • Fred Hutchinson Cancer Center — Seattle, Washington, United States
  • University of Washington Medical Center - Montlake — Seattle, Washington, United States
  • Marshfield Medical Center-EC Cancer Center — Eau Claire, Wisconsin, United States
  • Marshfield Medical Center — Marshfield, Wisconsin, United States
  • Froedtert Menomonee Falls Hospital — Menomonee Falls, Wisconsin, United States
  • Medical College of Wisconsin — Milwaukee, Wisconsin, United States
  • Marshfield Medical Center — Minocqua, Wisconsin, United States
  • Froedtert and MCW Moorland Reserve Health Center — New Berlin, Wisconsin, United States
  • Drexel Town Square Health Center — Oak Creek, Wisconsin, United States
  • Marshfield Medical Center — Rice Lake, Wisconsin, United States
  • Marshfield Med Ctr-River Region at Stevens Point — Stevens Point, Wisconsin, United States
  • Froedtert West Bend Hospital/Kraemer Cancer Center — West Bend, Wisconsin, United States
  • Marshfield Medical Center — Weston, Wisconsin, United States
  • Princess Alexandra Hospital - University Of Queensland — Woolloongabba, Queensland, Australia
  • Peter Maccallum Cancer Institute — Melbourne, Victoria, Australia
  • Chris O'Brian Life House - Chris O'Brien Lifehouse — Camperdown, Australia
  • BCCA - Vancouver Cancer Centre — Vancouver, British Columbia, Canada
  • London Regional Cancer Center — London, Ontario, Canada
  • The Ottawa Hospital - General Campus — Ottawa, Ontario, Canada
  • Hopital Maisonneuve Rosemont — Montreal, Quebec, Canada
  • The Research Institute of the McGill University Health Centre — Montreal, Quebec, Canada
  • Mount Sinai Hospital — Toronto, Canada
  • Bank Of Cyprus Oncology Centre — Stróvolos, Cyprus
  • Masaryk Memorial Cancer Institute — Brno, Czechia
  • University Hospital Motol — Prague, Czechia
  • Herlev Hospital - University Copenhagen — Herlev, Copenhagen, Denmark
  • Aarhus University Hospitals - Aarhus University Hospital-Skejby — Aarhus, Denmark
  • Centre Leon Berard — Lyon, France
  • Institut du Cancer de Montpellier — Montpellier, France
  • Institut Curie- Hopital de Paris — Paris, France
  • Hopitaux Universitaires de Strasbourg - Hautepierre — Strasbourg, France
  • Institut Gustave Roussy — Villejuif, France
  • Universitaetsmedizin Goettingen - Georg-August Universitaet — Goettigen, Lower Saxony, Germany
  • Universitaetsklinikum Carl Gustav Carus — Dresden, Germany
  • UniversitaetsMedizin Mannheim — Mannheim, Germany
  • Centro Di Riferimento Oncologico — Aviano, Italy
  • IRCCS - Fondazione Piemonte Inst di Candiolo — Candiolo, Italy
  • IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" — Meldola, Italy
  • IRCCS - Istituto Nazionale dei Tumori — Milan, 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, Japan
  • Yokohama City University Hospital — Yokohama, Kanagawa, Japan
  • Kanagawa Cancer Center — Yokohama, Kanagawa, Japan
  • Tohoku University Hospital — Sendai, Miyagi, Japan
  • Aichi Cancer Center — Chikusa-ku, Nagoya, Japan
  • Nagoya University Hospital — Shōwaku, Nagoya, Japan
  • Niigata University Medical and Dental Hospital — Niigata, Niigata, Japan
  • Okayama University Hospital — Kita-ku, Okayama-ken, Japan
  • Osaka International Cancer Institute — Chuo-ku, Osaka, Japan
  • National Cancer Center Hospital — Chuo-ku, Tokyo, Japan
  • Cancer Institute Hospital of JFCR — Koto-ku, Tokyo, Japan
  • Saitama Medical Center, Jichi Medical University — Saitama, Japan
  • The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis — Amsterdam, Netherlands
  • Leiden University Medical Centre — Leiden, Netherlands
  • Radboudumc - Radboud University Medical Center Nijmegen — Nijmegen, Netherlands
  • Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology — Warsaw, Poland
  • National Cancer Institute — Bratislava, Slovakia
  • Hospital De La Santa Creu I Sant Pau — Barcelona, Spain
  • Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol — Barcelona, Spain
  • Hospital General Universitario Gregorio Maranon — Madrid, Spain
  • Hospital Universitario Fundacion Jimenez Diaz — Madrid, Spain
  • Hospital Universitario San Carlos — Madrid, Spain
  • University Hospitals Birmingham - Queen Elisabeth Medical Centre — Birmingham, United Kingdom
  • NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital — Glasgow, United Kingdom
  • Leeds Teaching Hospitals NHS Trust - St. James's University Hospital — Leeds, United Kingdom
  • the Royal Marsden Hospital — London, United Kingdom
  • Clatterbridge cancer center — Metropolitan Borough of Wirral, United Kingdom
  • Newcastle Hospitals - Freeman Hospital, Northern Centre For Cancer Care — Newcastle, United Kingdom
  • Nottingham University Hospitals NHS Trust - City Hospital — Nottingham, United Kingdom
  • Oxford University Hospitals NHS Trust - Churchill Hospital — Oxford, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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