EA7211 STRASS 2 High Risk Retroperitoneal Sarcoma - Clinical Trial

What is the Purpose of this Study?

We are doing this study to compare the usual treatments of surgery alone to using chemotherapy before surgery. We want to know if adding doxorubicin and ifosfamide chemotherapy for liposarcoma (LPS) or doxorubicin and dacarbazine chemotherapy for leiomyosarcoma (LMS) before surgery can improve the long-term survival for patients with these cancers.

What is the Condition Being Studied?

High-Risk RetroPeritoneal Sarcoma

Who Can Participate in the Study?

Adults ages 18+ who:

  • Are diagnosed with primary high-risk leiomyosarcoma of retroperitoneal space or infra-peritoneal spaces of pelvis that is either Grade 2 or 3 and has a minimum size of 5 cm; OR
  • Are diagnosed with primary high-risk liposarcoma of retroperitoneal space or infra-peritoneal spaces of pelvis that is Grade 2 or 3
  • Have unifocal tumor

For more information about who can join this study, please contact the study team at nick.jeffries@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, you will be randomly assigned (like a coin flip) to 1 of 2 groups:

  • Group 1 will get treatment with surgery alone
  • Group 2 will get treatment with chemotherapy before surgery
  • If you are assigned to Group 2, you will get 3 cycles of chemotherapy before your surgery. Each chemo cycle lasts 3 weeks. Your surgery will happen 3-6 weeks after your third and final cycle of chemotherapy. The chemotherapy drugs for both LMS and LPS study patients are given as an intravenous infusion (IV, through a vein in your arm) once per week.

    Study Details

    Full Title
    EA7211 A Randomized Phase III Study of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery Alone for Patients with High Risk RetroPeritoneal Sarcoma (STRASS 2)
    Principal Investigator
    Medical Oncologist
    Protocol Number
    IRB: PRO00113761
    NCT: NCT04031677
    Phase
    Phase III
    ClinicalTrials.gov
    Enrollment Status
    Open for Enrollment