Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma

Recruiting now · Phase 3

Conditions studied: Retroperitoneal Sarcoma, Liposarcoma, Leiomyosarcoma

In brief

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.

Key facts

Study ID

NCT04031677

Run by

European Organisation for Research and Treatment of Cancer - EORTC

People needed

250

Starts

2021-01-20

Expected to finish

2028-04-21

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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.

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.
• 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

Where it is running

• Mayo Clinic Hospital in Arizona — Phoenix, Arizona, United States (enrolling)
• City of Hope Comprehensive Cancer Center — Duarte, California, United States (enrolling)
• UCI Health-Chao Family Comp CC and Ambulatory Care — Irvine, California, United States (enrolling)
• UC San Diego Moores Cancer Center — La Jolla, California, United States (enrolling)
• UC Irvine Health/Chao Family Comprehensive Ca Ctr — Orange, California, United States (enrolling)
• UCHealth University of Colorado Hospital — Aurora, Colorado, United States (enrolling)
• Smilow Cancer Hospital-Derby Care Center — Derby, Connecticut, United States (enrolling)
• Smilow Cancer Hospital Care Center-Fairfield — Fairfield, Connecticut, United States (enrolling)
• Smilow Cancer Hospital Care Center at Glastonbury — Glastonbury, Connecticut, United States (enrolling)
• Smilow Cancer Hospital Care Center at Greenwich — Greenwich, Connecticut, United States (enrolling)
• Smilow Cancer Hospital Care Center - Guiford — Guilford, Connecticut, United States (enrolling)
• Smilow Cancer Hospital Care Ctr at Saint Francis — Hartford, Connecticut, United States (enrolling)
• Yale University — New Haven, Connecticut, United States (enrolling)
• Yale-New Haven Hospital North Haven Medical Center — North Haven, Connecticut, United States (enrolling)
• Smilow Cancer Hospital Care Center at Long Ridge — Stamford, Connecticut, United States (enrolling)
• Smilow Cancer Hospital Care Center-Trumbull — Trumbull, Connecticut, United States (enrolling)
• Smilow Cancer Hospital-Waterbury Care Center — Waterbury, Connecticut, United States (enrolling)
• Smilow Cancer Hospital Care Center - Waterford — Waterford, Connecticut, United States (enrolling)
• Univ of Florida Health Science Ctr - Gainesville — Gainesville, Florida, United States (enrolling)
• Mayo Clinic in Florida — Jacksonville, Florida, United States (enrolling)
• Moffitt Cancer Center-International Plaza — Tampa, Florida, United States (enrolling)
• Moffitt Cancer Center - McKinley Campus — Tampa, Florida, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Emory University Hospital Midtown — Atlanta, Georgia, United States (enrolling)
• Rush University Medical Center — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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