Retroperitoneal SarcomaPhase 3STRASS2NCT04031677
Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma
A Phase 3 study testing Surgery and Preoperative chemotherapy in people with Retroperitoneal Sarcoma and Liposarcoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 176 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retroperitoneal Sarcoma, Liposarcoma, Leiomyosarcoma
- What is being tested?
- Surgery and Preoperative chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 176 sitesin 15 countries
- Study dates
- 20 Jan 2021to 21 Apr 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 39Show fewer
- 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.
Who cannot join
- 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
Show all 26Show fewer
- 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
- 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.
- 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.
Trial locations and contacts
176 sites in 15 countries. Contact the study team or a site near you to ask about taking part.
176 sites in 15 countries
United States116 sites, 103 recruiting
- Recruiting
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
- Recruiting
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
- Withdrawn
Johns Hopkins Univ/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21205
- Recruiting
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805
- Recruiting
Our Lady of The Lake Hospital
Baton Rouge, Louisiana, 70808
- Recruiting
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808
- Recruiting
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123
- Recruiting
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, 56601
- Withdrawn
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
- Withdrawn
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
- Recruiting
Dana-Farber/Harvard Cancer Center
Boston, Massachusetts, 02215
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
- Recruiting
University of Vermont Medical Center
Burlington, Vermont, 05401
- Recruiting
Vermont Regional Cancer Center
Burlington, Vermont, 05405
- Recruiting
Cooper Hospital University Medical Center
Camden, New Jersey, 08103
- Recruiting
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203
- Withdrawn
Northwestern University
Chicago, Illinois, 60611
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
- Recruiting
University of Illinois at Chicago MBCCOP
Chicago, Illinois, 60612
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
- Recruiting
Siteman Cancer Center-West County
Creve Coeur, Missouri, 63141
- Recruiting
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
- Recruiting
Smilow Cancer Hospital-Derby Care Center
Derby, Connecticut, 06418
- Recruiting
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
- Recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701
- Recruiting
Saint Vincent Hospital
Erie, Pennsylvania, 16544
- Recruiting
Smilow Cancer Hospital Care Center-Fairfield
Fairfield, Connecticut, 06824
- Withdrawn
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
- Withdrawn
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58122
- Recruiting
Univ of Florida Health Science Ctr - Gainesville
Gainesville, Florida, 32610
- Recruiting
Smilow Cancer Hospital Care Center at Glastonbury
Glastonbury, Connecticut, 06033
- Recruiting
Smilow Cancer Hospital Care Center at Greenwich
Greenwich, Connecticut, 06830
- Recruiting
Smilow Cancer Hospital Care Center - Guiford
Guilford, Connecticut, 06437
- Recruiting
HMH-Hackensack University Medical Center
Hackensack, New Jersey, 07601
- Recruiting
Smilow Cancer Hospital Care Ctr at Saint Francis
Hartford, Connecticut, 06105
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
- Withdrawn
Indiana Univ/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
- Recruiting
UCI Health-Chao Family Comp CC and Ambulatory Care
Irvine, California, 92612
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
- Recruiting
Jefferson Hospital
Jefferson Hills, Pennsylvania, 15025
- Recruiting
University of Kansas Cancer Center
Kansas City, Kansas, 66160
- Recruiting
University of Tennessee - Knoxville
Knoxville, Tennessee, 37920
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92093
- Recruiting
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
- Withdrawn
Dartmouth Hitchcock Med Ctr/Dartmouth Cancer Ctr
Lebanon, New Hampshire, 03756
- Recruiting
James Graham Brown Ca Ctr at Univ of Louisville
Louisville, Kentucky, 40202
- Recruiting
UofL Health Medical Center Northeast
Louisville, Kentucky, 40245
- Recruiting
North Shore University Hospital
Manhasset, New York, 11030
- Recruiting
Marshfield Medical Center
Marshfield, Wisconsin, 54449
- Recruiting
VCU Massey Cancer Center at Hanover Medical Park
Mechanicsville, Virginia, 23116
- Recruiting
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
- Recruiting
NYU Langone Hospital - Long Island
Mineola, New York, 11501
- Recruiting
Marshfield Medical Center
Minocqua, Wisconsin, 54548
- Recruiting
Forbes Hospital
Monroeville, Pennsylvania, 15146
- Recruiting
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
- Recruiting
Allegheny Valley Hospital
Natrona Heights, Pennsylvania, 15065
- Recruiting
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
- Recruiting
Froedtert and MCW Moorland Reserve Health Center
New Berlin, Wisconsin, 53151
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
- Recruiting
Yale University
New Haven, Connecticut, 06520
- Recruiting
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
- Recruiting
Laura and Issac Perlmutter Ca Ctr at NYU Langone
New York, New York, 10016
- Recruiting
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, 06385
- Recruiting
Drexel Town Square Health Center
Oak Creek, Wisconsin, 53154
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
- Recruiting
Nebraska Medicine-Bellevue
Omaha, Nebraska, 68118
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
- Recruiting
UC Irvine Health/Chao Family Comprehensive Ca Ctr
Orange, California, 92668
- Recruiting
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210
- Recruiting
John Theurer Cancer Center at From Road
Paramus, New Jersey, 07652
- Recruiting
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
- Recruiting
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
- Recruiting
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054
- Recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
- Recruiting
West Penn Hospital
Pittsburgh, Pennsylvania, 15224
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
- Recruiting
Renown Regional Medical Center
Reno, Nevada, 89502
- Recruiting
Marshfield Medical Center
Rice Lake, Wisconsin, 54868
- Recruiting
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
- Recruiting
Virginia Commonwealth Univ/Massey Cancer Center
Richmond, Virginia, 23298
- Recruiting
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
- Recruiting
University of Rochester
Rochester, New York, 14642
- Recruiting
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84132
- Withdrawn
FHCC South Lake Union
Seattle, Washington, 98109
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
- Recruiting
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
- Withdrawn
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104
- Withdrawn
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117
- Withdrawn
VCU Community Memorial Health Center
South Hill, Virginia, 23970
- Recruiting
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, 63110
- Recruiting
Siteman Cancer Center-South Country
St Louis, Missouri, 63129
- Recruiting
Smilow Cancer Hospital Care Center at Long Ridge
Stamford, Connecticut, 06902
- Recruiting
Marshfield Med Ctr-River Region at Stevens Point
Stevens Point, Wisconsin, 54482
- Withdrawn
Stony Brook University Medical Center
Stony Brook, New York, 11794
- Recruiting
Moffitt Cancer Center-International Plaza
Tampa, Florida, 33607
- Recruiting
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, 33612
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
- Recruiting
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461
- Recruiting
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
- Recruiting
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, 06611
- Recruiting
Smilow Cancer Hospital-Waterbury Care Center
Waterbury, Connecticut, 06708
- Recruiting
Smilow Cancer Hospital Care Center - Waterford
Waterford, Connecticut, 06385
- Recruiting
Froedtert West Bend Hospital/Kraemer Cancer Center
West Bend, Wisconsin, 53095
- Recruiting
Smilow Cancer Hospital Care Center - Westerly
Westerly, Rhode Island, 02891
- Recruiting
Marshfield Medical Center
Weston, Wisconsin, 54476
- Recruiting
University of Kansas Hospital-Westwood Cancer Ctr
Westwood, Kansas, 66205
- Recruiting
Wexford Health and Wellness Pavilion
Wexford, Pennsylvania, 15090
- Recruiting
Midwestern Regional Medical Center
Zion, Illinois, 60099
Japan12 sites, 12 recruiting
- Recruiting
Aichi Cancer Center
Chikusa-ku, Nagoya, 464-8681
- Recruiting
Osaka International Cancer Institute
Chuo-ku, Osaka, 541-8567
- Recruiting
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
- Recruiting
Kyushu University Hospital
Higashiku, Fukuoka, 812-8582
- Recruiting
Okayama University Hospital
Kita-ku, Okayama-ken, 700-8558
- Recruiting
Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550
- Recruiting
Niigata University Medical and Dental Hospital
Niigata, Niigata, 951-8520
- Recruiting
Saitama Medical Center, Jichi Medical University
Saitama, 330-8503
- Recruiting
Tohoku University Hospital
Sendai, Miyagi, 780-8574
- Recruiting
Nagoya University Hospital
Shōwaku, Nagoya, 466-8550
- Recruiting
Yokohama City University Hospital
Yokohama, Kanagawa, 236-0004
- Recruiting
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515
Italy8 sites, 7 recruiting
- Withdrawn
Centro Di Riferimento Oncologico
Aviano, 33081
- Recruiting
IRCCS - Fondazione Piemonte Inst di Candiolo
Candiolo
- Recruiting
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola
- Recruiting
IRCCS - Istituto Nazionale dei Tumori
Milan, 20133
- Recruiting
Istituto Clinico Humanitas
Milan
- Recruiting
Istituto Europeo di Oncologia
Milan
- Recruiting
IRCCS - Istituto Oncologico Veneto
Padova
- Recruiting
Policlinico Universitario Campus Bio-Medico- Oncology Center
Roma
United Kingdom8 sites, 6 recruiting
- Recruiting
University Hospitals Birmingham - Queen Elisabeth Medical Centre
Birmingham, B15 2TH
- Withdrawn
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital
Glasgow
- Recruiting
Leeds Teaching Hospitals NHS Trust - St. James's University Hospital
Leeds, LS9 7TF
- Recruiting
the Royal Marsden Hospital
London
- Recruiting
Clatterbridge cancer center
Metropolitan Borough of Wirral, CH63 4JY
- Not yet recruiting
Newcastle Hospitals - Freeman Hospital, Northern Centre For Cancer Care
Newcastle, NE7 7DN
- Recruiting
Nottingham University Hospitals NHS Trust - City Hospital
Nottingham, NG5 1PB
- Withdrawn
Oxford University Hospitals NHS Trust - Churchill Hospital
Oxford, OX3 7LE
Canada6 sites, 6 recruiting
- Recruiting
London Regional Cancer Center
London, Ontario, N6A 4L6
- Recruiting
Hopital Maisonneuve Rosemont
Montreal, Quebec, H1T 2M4
- Recruiting
The Research Institute of the McGill University Health Centre
Montreal, Quebec, H4A3J1
- Recruiting
The Ottawa Hospital - General Campus
Ottawa, Ontario
- Recruiting
Mount Sinai Hospital
Toronto
- Recruiting
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
France5 sites, 3 recruiting
- Recruiting
Centre Leon Berard
Lyon, 69008
- Withdrawn
Institut du Cancer de Montpellier
Montpellier, 34298
- Recruiting
Institut Curie- Hopital de Paris
Paris, 75248
- Withdrawn
Hopitaux Universitaires de Strasbourg - Hautepierre
Strasbourg, 67098
- Recruiting
Institut Gustave Roussy
Villejuif, 94805
Spain5 sites, 5 recruiting
- Recruiting
Hospital De La Santa Creu I Sant Pau
Barcelona, 08041
- Recruiting
Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol
Barcelona
- Recruiting
Hospital General Universitario Gregorio Maranon
Madrid, 28007
- Not yet recruiting
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
- Recruiting
Hospital Universitario San Carlos
Madrid, 28040
Australia3 sites, 3 recruiting
- Recruiting
Chris O'Brian Life House - Chris O'Brien Lifehouse
Camperdown, 2050
- Recruiting
Peter Maccallum Cancer Institute
Melbourne, Victoria, 3000
- Recruiting
Princess Alexandra Hospital - University Of Queensland
Woolloongabba, Queensland, QLD 4102
Germany3 sites, 2 recruiting
- Withdrawn
Universitaetsklinikum Carl Gustav Carus
Dresden, 01307
- Recruiting
Universitaetsmedizin Goettingen - Georg-August Universitaet
Goettigen, Lower Saxony, 37075
- Recruiting
UniversitaetsMedizin Mannheim
Mannheim, 68167
Netherlands3 sites, 3 recruiting
- Recruiting
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
Amsterdam, 1066
- Recruiting
Leiden University Medical Centre
Leiden, 2300 RC
- Recruiting
Radboudumc - Radboud University Medical Center Nijmegen
Nijmegen, 6525
Czechia2 sites, 2 recruiting
- Recruiting
Masaryk Memorial Cancer Institute
Brno, 656 53
- Not yet recruiting
University Hospital Motol
Prague, 150 06
Denmark2 sites, 2 recruiting
- Recruiting
Aarhus University Hospitals - Aarhus University Hospital-Skejby
Aarhus, 8250
- Recruiting
Herlev Hospital - University Copenhagen
Herlev, Copenhagen, 2730
Poland1 site, 1 recruiting
- Recruiting
Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw
Slovakia1 site, 1 recruiting
- Recruiting
National Cancer Institute
Bratislava, SK 833 10
About this study
Official title: 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.
Read the 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
- Conditions
- Retroperitoneal Sarcoma, Liposarcoma, Leiomyosarcoma
- Being tested
- Surgery, Preoperative chemotherapy
- Medical subject headings
- Liposarcoma, Leiomyosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Large en-bloc curative-intent surgery
Preoperative chemotherapyDrug
Also called neoadjuvant 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.
| Study group | Role | What they receive |
|---|---|---|
| Standard arm | Other | Surgery alone Receives: Procedure: Surgery |
| Experimental arm | Experimental | Preoperative chemotherapy and surgery Receives: Drug: Preoperative chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 years from first patient in
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 years from first patient in
Pathological response
Response evaluation will be done according to the EORTC response score.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 years from first patient in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start20 Jan 2021
- Primary completion21 Apr 2027 (estimated)
- Study completion21 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retroperitoneal SarcomaStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- Research network
- Collaborators
- Canadian Cancer Trials Group, ECOG-ACRIN Cancer Research Group, Anticancer Fund, Belgium, Australia and New Zealand Sarcoma Association, Japan Clinical Oncology Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031677
- Sponsor's protocol ID
- EORTC 1809-STBSG
- Other IDs
- EA7211, SR.7, ASSG45, JCOG2214INT
- Acronym
- STRASS2
- Status last verified
- Oct 2026
- First submitted
- 22 Jul 2019
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nardi W, Nicolas N, El Zein S, Tzanis D, Bouhadiba T, Helfre S, Watson S, Brisse HJ, Servois V, Bonvalot S. Diagnostic accuracy and safety of percutaneous core needle biopsy of retroperitoneal tumours. Eur J Surg Oncol. 2024 Jan;50(1):107298. doi: 10.1016/j.ejso.2023.107298. Epub 2023 Nov 30.
PubMed 38086314