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)
5 other identifiers
interventional
250
15 countries
164
Brief Summary
This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival. After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2021
Longer than P75 for phase_3
164 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2019
CompletedFirst Posted
Study publicly available on registry
July 24, 2019
CompletedStudy Start
First participant enrolled
January 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 21, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 21, 2028
March 31, 2026
March 1, 2026
6.3 years
July 22, 2019
March 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (13)
Overall survival (OS)
8 years from first patient in
Recurrence free survival
8 years from first patient in
Distant metastases free survival
8 years from first patient in
Cumulative incidence of local recurrences
8 years from first patient in
Cumulative incidence of distant metastases
8 years from first patient in
- +8 more secondary outcomes
Study Arms (2)
Standard arm
OTHERSurgery alone
Experimental arm
EXPERIMENTALPreoperative chemotherapy and surgery
Interventions
* 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
You may qualify if:
- 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
- +24 more criteria
You may not qualify if:
- 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.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- European Organisation for Research and Treatment of Cancer - EORTClead
- Canadian Cancer Trials Groupcollaborator
- ECOG-ACRIN Cancer Research Groupcollaborator
- Anticancer Fund, Belgiumcollaborator
- Australia and New Zealand Sarcoma Associationcollaborator
- Japan Clinical Oncology Groupcollaborator
Study Sites (164)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
UCI Health-Chao Family Comp CC and Ambulatory Care
Irvine, California, 92612, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
UC Irvine Health/Chao Family Comprehensive Ca Ctr
Orange, California, 92668, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045, United States
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, 06418, United States
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, 06824, United States
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, 06033, United States
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, 06830, United States
Smilow Cancer Hospital Care Center - Guiford
Guilford, Connecticut, 06437, United States
Smilow Cancer Hospital Care Ctr at Saint Francis
Hartford, Connecticut, 06105, United States
Yale University
New Haven, Connecticut, 06520, United States
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, 06385, United States
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, 06902, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, 06611, United States
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, 06708, United States
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, 06385, United States
Univ of Florida Health Science Ctr - Gainesville
Gainesville, Florida, 32610, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
Moffitt Cancer Center-International Plaza
Tampa, Florida, 33607, United States
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, 33612, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Illinois at Chicago MBCCOP
Chicago, Illinois, 60612, United States
Indiana Univ/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210, United States
University of Kansas Hospital-Westwood Cancer Ctr
Westwood, Kansas, 66205, United States
James Graham Brown Ca Ctr at Univ of Louisville
Louisville, Kentucky, 40202, United States
UofL Health Medical Center Northeast
Louisville, Kentucky, 40245, United States
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805, United States
Our Lady of The Lake Hospital
Baton Rouge, Louisiana, 70808, United States
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808, United States
Johns Hopkins Univ/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21205, United States
Dana-Farber/Harvard Cancer Center
Boston, Massachusetts, 02215, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Siteman Cancer Center-West County
Creve Coeur, Missouri, 63141, United States
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, 63110, United States
Siteman Cancer Center-South Country
St Louis, Missouri, 63129, United States
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123, United States
Nebraska Medicine-Bellevue
Omaha, Nebraska, 68118, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Dartmouth Hitchcock Med Ctr/Dartmouth Cancer Ctr
Lebanon, New Hampshire, 03756, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
HMH-Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
John Theurer Cancer Center at From Road
Paramus, New Jersey, 07652, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
NYU Langone Hospital - Long Island
Mineola, New York, 11501, United States
Laura and Issac Perlmutter Ca Ctr at NYU Langone
New York, New York, 10016, United States
University of Rochester
Rochester, New York, 14642, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Saint Vincent Hospital
Erie, Pennsylvania, 16544, United States
Jefferson Hospital
Jefferson Hills, Pennsylvania, 15025, United States
Forbes Hospital
Monroeville, Pennsylvania, 15146, United States
Allegheny Valley Hospital
Natrona Heights, Pennsylvania, 15065, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
West Penn Hospital
Pittsburgh, Pennsylvania, 15224, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Wexford Health and Wellness Pavilion
Wexford, Pennsylvania, 15090, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Smilow Cancer Hospital Care Center - Westerly
Westerly, Rhode Island, 02891, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117, United States
University of Tennessee - Knoxville
Knoxville, Tennessee, 37920, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84132, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
Vermont Regional Cancer Center
Burlington, Vermont, 05405, United States
VCU Massey Cancer Center at Hanover Medical Park
Mechanicsville, Virginia, 23116, United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235, United States
Virginia Commonwealth Univ/Massey Cancer Center
Richmond, Virginia, 23298, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014, United States
VCU Community Memorial Health Center
South Hill, Virginia, 23970, United States
FHCC South Lake Union
Seattle, Washington, 98109, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
University of Washington Medical Center - Montlake
Seattle, Washington, 98195, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701, United States
Marshfield Medical Center
Marshfield, Wisconsin, 54449, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Marshfield Medical Center
Minocqua, Wisconsin, 54548, United States
Marshfield Medical Center
Rice Lake, Wisconsin, 54868, United States
Marshfield Med Ctr-River Region at Stevens Point
Stevens Point, Wisconsin, 54482, United States
Marshfield Medical Center
Weston, Wisconsin, 54476, United States
Princess Alexandra Hospital - University Of Queensland
Woolloongabba, Queensland, QLD 4102, Australia
Peter Maccallum Cancer Institute
Melbourne, Victoria, 3000, Australia
Chris O'Brian Life House - Chris O'Brien Lifehouse
Camperdown, 2050, Australia
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
London Regional Cancer Center
London, Ontario, N6A 4L6, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
Hopital Maisonneuve Rosemont
Montreal, Quebec, H1T 2M4, Canada
The Research Institute of the McGill University Health Centre
Montreal, Quebec, H4A3J1, Canada
Mount Sinai Hospital
Toronto, Canada
Bank Of Cyprus Oncology Centre
Stróvolos, 2006, Cyprus
Masaryk Memorial Cancer Institute
Brno, 656 53, Czechia
Herlev Hospital - University Copenhagen
Herlev, Copenhagen, 2730, Denmark
Aarhus University Hospitals - Aarhus University Hospital-Skejby
Aarhus, 8250, Denmark
Centre Leon Berard
Lyon, 69008, France
Institut du Cancer de Montpellier
Montpellier, 34298, France
Institut Curie- Hopital de Paris
Paris, 75248, France
Hopitaux Universitaires de Strasbourg - Hautepierre
Strasbourg, 67098, France
Institut Gustave Roussy
Villejuif, 94805, France
Universitaetsmedizin Goettingen - Georg-August Universitaet
Goettigen, Lower Saxony, 37075, Germany
Universitaetsklinikum Carl Gustav Carus
Dresden, 01307, Germany
UniversitaetsMedizin Mannheim
Mannheim, 68167, Germany
Centro Di Riferimento Oncologico
Aviano, 33081, Italy
IRCCS - Fondazione Piemonte Inst di Candiolo
Candiolo, Italy
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola, Italy
IRCCS - Istituto Nazionale dei Tumori
Milan, 20133, Italy
Istituto Clinico Humanitas
Milan, Italy
Istituto Europeo di Oncologia
Milan, Italy
IRCCS - Istituto Oncologico Veneto
Padua, Italy
Policlinico Universitario Campus Bio-Medico- Oncology Center
Roma, Italy
Kyushu University Hospital
Higashiku, Fukuoka, 812-8582, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, 236-0004, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515, Japan
Tohoku University Hospital
Sendai, Miyagi, 780-8574, Japan
Aichi Cancer Center
Chikusa-ku, Nagoya, 464-8681, Japan
Nagoya University Hospital
Shōwaku, Nagoya, 466-8550, Japan
Niigata University Medical and Dental Hospital
Niigata, Niigata, 951-8520, Japan
Okayama University Hospital
Kita-ku, Okayama-ken, 700-8558, Japan
Osaka International Cancer Institute
Chuo-ku, Osaka, 541-8567, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550, Japan
Saitama Medical Center, Jichi Medical University
Saitama, 330-8503, Japan
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
Amsterdam, 1066, Netherlands
Leiden University Medical Centre
Leiden, 2300 RC, Netherlands
Radboudumc - Radboud University Medical Center Nijmegen
Nijmegen, 6525, Netherlands
Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, Poland
National Cancer Institute
Bratislava, SK 833 10, Slovakia
Hospital De La Santa Creu I Sant Pau
Barcelona, 08041, Spain
Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol
Barcelona, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28007, Spain
Hospital Universitario San Carlos
Madrid, 28040, Spain
University Hospitals Birmingham - Queen Elisabeth Medical Centre
Birmingham, B15 2TH, United Kingdom
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital
Glasgow, United Kingdom
Leeds Teaching Hospitals NHS Trust - St. James's University Hospital
Leeds, LS9 7TF, United Kingdom
the Royal Marsden Hospital
London, United Kingdom
Clatterbridge cancer center
Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
Newcastle Hospitals - Freeman Hospital, Northern Centre For Cancer Care
Newcastle, NE7 7DN, United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital
Nottingham, NG5 1PB, United Kingdom
Oxford University Hospitals NHS Trust - Churchill Hospital
Oxford, OX3 7LE, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2019
First Posted
July 24, 2019
Study Start
January 20, 2021
Primary Completion (Estimated)
April 21, 2027
Study Completion (Estimated)
April 21, 2028
Last Updated
March 31, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share