Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma

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.

Trial Details

NCT ID
NCT04031677
Phase
PHASE3
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Status
RECRUITING
Cancer Type
Liposarcoma Sarcoma
Interventions
  • Surgery
  • Preoperative chemotherapy
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Duarte, California, United States|34.13945,-117.97729
  • Irvine, California, United States|33.66946,-117.82311
  • La Jolla, California, United States|32.84727,-117.2742

Key Eligibility Criteria

  • Histologically proven primary high risk leiomyosarcoma (LMS) or Liposarcoma (LPS) of retroperitoneal space or infra-peritoneal spaces of pelvis.
  • Any grade LMS can be included
  • Minimum size of LMS tumor should be 5 cm
  • Diagnosis should be confirmed based on MDM2 (Mouse double minute 2 homolog) and CDK4 (Cyclin-dependent kinase 4) expression on IHC (immunohistochem…

For full eligibility, visit ClinicalTrials.gov.

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