Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma
Trial Parameters
Brief 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. After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.
Eligibility 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