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JOURNAL ONKOLOGIE – STUDIE
STRASS2

Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma

Rekrutierend

NCT-Nummer:
NCT04031677

Studienbeginn:
Januar 2021

Letztes Update:
03.04.2024

Wirkstoff:
Preoperative chemotherapy

Indikation (Clinical Trials):
Sarcoma, Leiomyosarcoma, Liposarcoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC

Collaborator:
Canadian Cancer Trials Group, ECOG-ACRIN Cancer Research Group, Anticancer Fund, Belgium, Australia and New Zealand Sarcoma Association, Japan Clinical Oncology Group,

Kontakt

Studienlocations
(3 von 133)

Universitaetsmedizin Goettingen - Georg-August Universitaet
37075 Goettigen
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Carl Gustav Carus
01307 Dresden
(Sachsen)
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UniversitaetsMedizin Mannheim
68167 Mannheim
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Mayo Clinic Hospital in Arizona
85054 Phoenix
United StatesRekrutierend» Google-Maps
City of Hope Comprehensive Cancer Center
91010 Duarte
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UC Irvine Health/Chao Family Comprehensive Ca Ctr
92668 Orange
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UCHealth University of Colorado Hospital
80045 Aurora
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Smilow Cancer Hospital-Derby Care Center
06418 Derby
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Smilow Cancer Hospital Care Center-Fairfield
06824 Fairfield
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Smilow Cancer Hospital Care Center at Glastonbury
06033 Glastonbury
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Smilow Cancer Hospital Care Center at Greenwich
06830 Greenwich
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Smilow Cancer Hospital Care Center - Guiford
06437 Guilford
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Smilow Cancer Hospital Care Ctr at Saint Francis
06105 Hartford
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Yale-New Haven Hospital North Haven Medical Center
06385 North Haven
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Smilow Cancer Hospital Care Center at Long Ridge
06902 Stamford
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Smilow Cancer Hospital Care Center-Trumbull
06611 Trumbull
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Smilow Cancer Hospital-Waterbury Care Center
06708 Waterbury
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Smilow Cancer Hospital Care Center - Waterford
06385 Waterford
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Mayo Clinic in Florida
32224 Jacksonville
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Moffitt Cancer Center-International Plaza
33607 Tampa
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Moffitt Cancer Center - McKinley Campus
33612 Tampa
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Emory University Hospital Midtown
30308 Atlanta
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Northwestern University
60611 Chicago
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University of Illinois at Chicago MBCCOP
60612 Chicago
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University of Kansas Cancer Center
66160 Kansas City
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University of Kansas Cancer Center-Overland Park
66210 Overland Park
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University of Kansas Hospital-Westwood Cancer Ctr
66205 Westwood
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LSU Health Baton Rouge-North Clinic
70805 Baton Rouge
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Our Lady of The Lake Hospital
70808 Baton Rouge
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Our Lady of the Lake Physician Group
70808 Baton Rouge
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Johns Hopkins Univ/Sidney Kimmel Cancer Center
21205 Baltimore
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Dana-Farber/Harvard Cancer Center
02215 Boston
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University of Michigan Comprehensive Cancer Center
48109 Ann Arbor
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Sanford Joe Lueken Cancer Center
56601 Bemidji
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Siteman Cancer Center-West County
63141 Creve Coeur
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Washington University School of Medicine - Siteman Cancer Center
63110 Saint Louis
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Siteman Cancer Center-South Country
63129 Saint Louis
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Nebraska Medicine-Bellevue
68123 Bellevue
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Nebraska Medicine-Bellevue
68118 Omaha
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University of Nebraska Medical Center
68198 Omaha
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Dartmouth Hitchcock Med Ctr/Dartmouth Cancer Ctr
03756 Lebanon
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Roswell Park Cancer Institute
14263 Buffalo
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University of Rochester
14642 Rochester
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Duke University Medical Center
27710 Durham
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Sanford Bismarck Medical Center
58501 Bismarck
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Sanford Broadway Medical Center
58122 Fargo
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Sanford Roger Maris Cancer Center
58122 Fargo
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Ohio State University Comprehensive Cancer Center
43210 Columbus
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University of Oklahoma Health Sciences Center
73104 Oklahoma City
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Oregon Health and Science University
97239 Portland
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University of Pennsylvania/Abramson Cancer Center
19104 Philadelphia
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Pennsylvania Hospital
19107 Philadelphia
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Thomas Jefferson University Hospital
19107 Philadelphia
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Fox Chase Cancer Center
19111 Philadelphia
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UPMC Hillman Cancer Center
15232 Pittsburgh
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Smilow Cancer Hospital Care Center - Westerly
02891 Westerly
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Sanford Cancer Center Oncology Clinic
57104 Sioux Falls
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Sanford USD Medical Center - Sioux Falls
57117 Sioux Falls
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M D Anderson Cancer Center
77030 Houston
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Huntsman Cancer Institute/University of Utah
84132 Salt Lake City
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VCU Massey Cancer Center at Hanover Medical Park
23116 Mechanicsville
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VCU Massey Cancer Center at Stony Point
23235 Richmond
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Virginia Commonwealth Univ/Massey Cancer Center
23298 Richmond
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Carilion Roanoke Memorial Hospital
24014 Roanoke
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VCU Community Memorial Health Center
23970 South Hill
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Fred Hutchinson Cancer Center
98109 Seattle
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University of Washington Medical Center - Montlake
98195 Seattle
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Marshfield Medical Center-EC Cancer Center
54701 Eau Claire
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Marshfield Medical Center
54449 Marshfield
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Medical College of Wisconsin
53226 Milwaukee
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Marshfield Medical Center
54548 Minocqua
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Marshfield Medical Center
54868 Rice Lake
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Marshfield Med Ctr-River Region at Stevens Point
54482 Stevens Point
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Marshfield Medical Center
54476 Weston
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Princess Alexandra Hospital - University Of Queensland
QLD 4102 Woolloongabba
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Peter Maccallum Cancer Institute
3000 Melbourne
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Chris O'Brian Life House - Chris O'Brien Lifehouse
2050 Camperdown
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BCCA - Vancouver Cancer Centre
V5Z 4E6 Vancouver
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London Regional Cancer Center
N6A 4L6 London
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The Ottawa Hospital - General Campus
Ottawa
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Hopital Maisonneuve Rosemont
H1T 2M4 Montréal
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The Research Institute of the McGill University Health Centre
H4A3J1 Montréal
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Bank Of Cyprus Oncology Centre
2006 Stróvolos
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Masaryk Memorial Cancer Institute
656 53 Brno
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Herlev Hospital - University Copenhagen
2730 Herlev
DenmarkRekrutierend» Google-Maps
Aarhus University Hospitals - Aarhus University Hospital-Skejby
8250 Aarhus
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Institut du Cancer de Montpellier
34298 Montpellier
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Institut Curie- Hopital de Paris
75248 Paris
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Hopitaux Universitaires de Strasbourg - Hautepierre
67098 Strasbourg
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Centro Di Riferimento Oncologico
33081 Aviano
ItalyRekrutierend» Google-Maps
IRCCS - Fondazione Piemonte Inst di Candiolo
Candiolo
ItalyRekrutierend» Google-Maps
IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
Meldola
ItalyRekrutierend» Google-Maps
IRCCS - Istituto Nazionale dei Tumori
20133 Milan
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Policlinico Universitario Campus Bio-Medico- Oncology Center
Roma
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Kyushu University Hospital
812-8582 Higashi-ku
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Yokohama City University Hospital
236-0004 Yokohama
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Nagoya University Hospital
466-8550 Showa-ku
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Niigata University Medical and Dental Hospital
951-8520 Niigata City
JapanRekrutierend» Google-Maps
Okayama University Hospital
700-8558 Kita-ku
JapanRekrutierend» Google-Maps
Osaka International Cancer Institute
541-8567 Chuo-ku
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National Cancer Center Hospital
104-0045 Chuo-ku
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Cancer Institute Hospital of JFCR
135-8550 Koto-ku
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Saitama Medical Center, Jichi Medical University
330-8503 Saitama
JapanRekrutierend» Google-Maps
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
1066 Amsterdam
NetherlandsRekrutierend» Google-Maps
Leiden University Medical Centre
2300 RC Leiden
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Radboudumc - Radboud University Medical Center Nijmegen
6525 Nijmegen
NetherlandsRekrutierend» Google-Maps
Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw
PolandRekrutierend» Google-Maps
National Cancer Institute
SK 833 10 Bratislava
SlovakiaRekrutierend» Google-Maps
Hospital De La Santa Creu I Sant Pau
08041 Barcelona
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Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol
Barcelona
SpainRekrutierend» Google-Maps
Hospital General Universitario Gregorio Maranon
28007 Madrid
SpainNoch nicht rekrutierend» Google-Maps
Hospital Universitario San Carlos
28040 Madrid
SpainRekrutierend» Google-Maps
University Hospitals Birmingham - Queen Elisabeth Medical Centre
B15 2TH Birmingham
United KingdomRekrutierend» Google-Maps
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital
Glasgow
United KingdomRekrutierend» Google-Maps
Leeds Teaching Hospitals NHS Trust - St. James's University Hospital
LS9 7TF Leeds
United KingdomRekrutierend» Google-Maps
Newcastle Hospitals - Freeman Hospital, Northern Centre For Cancer Care
NE7 7DN Newcastle
United KingdomNoch nicht rekrutierend» Google-Maps
Nottingham University Hospitals NHS Trust - City Hospital
NG5 1PB Nottingham
United KingdomRekrutierend» Google-Maps
Oxford University Hospitals NHS Trust - Churchill Hospital
OX3 7LE Oxford
United KingdomRekrutierend» Google-Maps
Clatterbridge cancer center
CH63 4JY Wirral
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Alle anzeigen

Studien-Informationen

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

Ein-/Ausschlusskriterien

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), has no necrosis on the biopsy but clear necrosis on

imaging.

- The tumors carry a high risk gene profile as determined by the Complexity

INdex in SARComas (CINSARC-high)

- Representative formalin fixed, paraffin embedded tumor blocks or unstained tissue

slides must be available at baseline for histological central review.

- Unifocal tumor

- Absence of extension through the sciatic notch or across the diaphragm

- Resectable tumor: 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

patients 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

- Tumor not previously treated (no previous surgery (excluding diagnostic biopsy),

radiotherapy or systemic therapy)

- Patient must have radiologically measurable disease (RECIST 1.1), as confirmed by

imaging within the 28 days prior to randomization. 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.

- ≥ 18 years old (no upper age limit)

- WHO (World Health Organization) performance status ≤ 2

- Adequate haematological and organ function:

- Haematological: haemoglobin > 9.0 g/dL or 5.6 mmol/L, absolute neutrophils > 1.5

x 109/L, platelets > 100 x 109/L Note: Platelet transfusions is allowed to

achieve these baseline values

- Renal: estimated glomerular filtration rate (eGFR) > 50 ml/min/m2; No proteinuria

CTCAE ≥ grade 2;

- Hepatic: Bilirubin ≤ 1.0 times upper limit of normal (1.0xULN) of institutional

limits, ALT (alanine aminotransferase) and/or AST (aspartate transaminase) ≤1.5 x

ULN. If isolated elevated bilirubin <2 x ULN and Gilberts syndrome suspected,

suggest repeating bloods after food. If bilirubin improves to meet the criteria

above this is acceptable. More severe persistent hepatic impairment of whatever

cause would exclude the patient from treatment till resolved.

- Heart: Clinically normal cardiac function based on left ventricular ejection

fraction (LVEF ≥ 50%) as assessed either by multi-gated acquisition scan (MUGA)

or cardiac ultrasound and 12 lead ECG without clinically relevant abnormalities.

- American Society of Anesthesiologist (ASA) score < 3

- Women of child bearing potential (WOCBP) must have a negative serum pregnancy test

within 7 days prior to the first dose of study treatment or surgery.

Note: a woman is considered of childbearing potential (WOCBP), i.e. fertile, following

menarche and until becoming post menopausal unless 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 months of amenorrhea, a single

FSH measurement is insufficient..

- Patients of childbearing / reproductive potential should use highly effective birth

control measures, as defined by the investigator, during the study treatment period

and for at least 6 months after the last dose of treatment or date of surgery. 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. Such

methods include:

- Combined (oestrogen and progestogen containing) hormonal contraception associated

with inhibition of ovulation (oral, intravaginal, transdermal)

- Progestogen-only hormonal contraception associated with inhibition of ovulation

(oral, injectable, implantable)

- Intrauterine device (IUD)

- Intrauterine hormone-releasing system (IUS)

- Bilateral tubal occlusion

- Vasectomized partner

- Sexual abstinence (the reliability of sexual abstinence needs to be evaluated in

relation to the duration of the clinical trial and the preferred and usual

lifestyle of the patient)

- Female subjects who are breast feeding should discontinue nursing prior to the first

day of study treatment and until 6 months after the last study treatment.

- Before patient registration/randomization, written informed consent must be given

according to ICH/GCP, and national/local regulations.

Exclusion Criteria:

- Sarcoma originated from bone structure, abdominal or gynecological viscera

- Metastatic disease

- Tumors with extension through the sciatic notch or across the diaphragm

- Hypersensitivity to doxorubicin, ifosfamide, dacarbazine or to any of their

metabolites or to any of their excipients

- Persistent myelosuppression

- Myocardial infarction within the last 6 months

- Uncontrolled cardiac arrhythmia

- Previous treatment with maximum cumulative doses (450mg/m² Doxorubicin or equivalent

900mg/m² EpiADM) 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 presumably cured

prostate cancer.

- Uncontrolled severe illness, infection,medical condition (including, uncontrolled

diabetes or hypertension), 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

Studien-Rationale

Primary outcome:

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



Secondary outcome:

1. Overall survival (OS) (Time Frame - 8 years from first patient in):
OS will be measured from the date of randomization to the date of death, whatever the cause.

2. Local recurrence free survival (Time Frame - 8 years from first patient in):
Local recurrence free survival will be measured from the date of randomization to the date of recurrence (local) or death, whichever occurs first.

3. Recurrence free survival (Time Frame - 8 years from first patient in):
Recurrence free survival will be measured from the date of randomization to the date of recurrence (local or distant) or death, whichever occurs first.

4. Distant metastases free survival (Time Frame - 8 years from first patient in):
Distant metastases free survival will be measured from the date of randomization to the date of distant metastases or death, whichever occurs first.

Studien-Arme

  • Other: Standard arm
    Surgery alone
  • Experimental: Experimental arm
    Preoperative chemotherapy and surgery

Geprüfte Regime

  • Surgery:
    Large en-bloc curative-intent surgery
  • Preoperative chemotherapy (neoadjuvant chemotherapy):
    - High grade LPS: ADM 75 mg/m2 (or the equivalent EpiADM 120 mg/m2) + ifosfamide 9 g/m2 Q3 weeks Note: the recommended dose of Ifosfamide can be modified according to national/institutional guidelines, given that the minimum threshold must be 7.5 g/m2 per cycle. - LMS: ADM 75 mg/m2 + DTIC 1g/m2 Q3 weeks

Quelle: ClinicalTrials.gov


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