EUCTR2019-003543-30-IT
Active, not recruiting
Phase 1
A randomized phase III study of neoadjuvant chemotherapy followed by surgery versus surgery alone for patients with High Risk RetroPeritoneal Sarcoma - STRASS 2
EORTC AISBL/IVZW0 sites250 target enrollmentOctober 21, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- EORTC AISBL/IVZW
- Enrollment
- 250
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically proven primary high risk leiomyosarcoma (LMS) or Liposarcoma (LPS) of retroperitoneal space or infra\-peritoneal spaces of pelvis.
- •\- LMS: \* Grades 2 and 3 LMS of minimum size 5 cm
- •\- LPS (diagnosis based on MDM2 and CDK4 expression on IHC; additional proof of MDM2 amplification is highly recommended but not mandatory):
- •\* Grade 3 DDLPS OR
- •\* Confirmed grade 2 DDLPS on biopsy only if: FNCLCC score \= 5 AND no necrosis on the biopsy but clear necrosis on imaging. OR
- •\* 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 performed within 28 days before randomization (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
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
- •Uncontrolled cardiac arrhythmia
Outcomes
Primary Outcomes
Not specified
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