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Looking for participantsPhase3

Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma

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

NCT ID: NCT04031677

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Surgery (procedure), Preoperative chemotherapy (drug)
How long the study runs
Study runs about 87 months (dates as stated)
About the drug or intervention
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.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
250
Started
2021-01-20
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for retroperitoneal sarcoma
  • • Phase3 - 250 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with retroperitoneal sarcoma

Where?

  • • Birmingham - University Hospitals Birmingham - Queen Elisabeth Medical Centre
  • • Glasgow - NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital
  • • Leeds - Leeds Teaching Hospitals NHS Trust - St. James's University Hospital
  • • London - the Royal Marsden Hospital
  • • +4 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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

Retroperitoneal SarcomaLiposarcomaLeiomyosarcoma

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

have a negative

Treatment history

Treatments you must have had:

  • ✓ radiologically measurable disease (RECIST 1
  • ✓ and if the patient fulfils all other eligibility criteria, he/she will be eligible
  • ✓ a negative serum pregnancy test within 3 days

What the study is looking for

  • ✓Histologically proven primary high risk leiomyosarcoma (LMS) or Liposarcoma (LPS) of retroperitoneal space or...
  • ✓Any grade LMS can be included
  • ✓Minimum size of LMS tumor should be 5 cm
  • ✓All grade 3 DDLPS can be included.
  • ✓DDLPS with confirmed grade 2 on biopsy can be included when:

Who cannot take part

  • ✗Sarcoma originating from bone structure, abdominal or gynecological viscera
  • ✗Extension through the sciatic notch or across the diaphragm
  • ✗that has spread disease
  • ✗Any previous surgery (excluding diagnostic biopsy), radiotherapy or treatment that goes through your whole body for the present tumour
  • ✗Hypersensitivity to doxorubicin, ifosfamide, dacarbazine or to any of their metabolites or to any of their excipients
See the full 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.

Where Is This Study? (8 UK sites)

University Hospitals Birmingham - Queen Elisabeth Medical Centre

Birmingham B15 2TH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital

Glasgow, United Kingdom

WITHDRAWN
Hospital R&D contact (matched)

Radek Penar

radoslaw.penar@nhs.scotn/a

Leeds Teaching Hospitals NHS Trust - St. James's University Hospital

Leeds LS9 7TF, United Kingdom

Recruiting
Hospital R&D contact (matched)

R&I Team

leedsth-tr.researchfacilitation@nhs.net0113 2060469

the Royal Marsden Hospital

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

Clatterbridge cancer center

Metropolitan Borough of Wirral CH63 4JY, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Maria Maguire

maria.maguire2@nhs.net0151 556 5321

Newcastle Hospitals - Freeman Hospital, Northern Centre For Cancer Care

Newcastle NE7 7DN, United Kingdom

NOT_YET_RECRUITING

Nottingham University Hospitals NHS Trust - City Hospital

Nottingham NG5 1PB, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924

Oxford University Hospitals NHS Trust - Churchill Hospital

Oxford OX3 7LE, United Kingdom

WITHDRAWN
Hospital R&D contact (matched)

Shahista Hussain

ouhtma@ouh.nhs.uk---

How to Get in Touch

EORTC HQ

Sponsor contact

CONTACT

+3227741611 1809@eortc.org
Data sourced from ClinicalTrials.gov · Last verified: 2026-10