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.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>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</li>
<li>Are diagnosed with primary high-risk liposarcoma of retroperitoneal space or infra-peritoneal spaces of pelvis that is Grade 2 or 3</li>
<li>Have unifocal tumor</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: nick.jeffries@duke.edu">nick.jeffries@duke.edu.</a>
<li>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</li>
<li>Are diagnosed with primary high-risk liposarcoma of retroperitoneal space or infra-peritoneal spaces of pelvis that is Grade 2 or 3</li>
<li>Have unifocal tumor</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: nick.jeffries@duke.edu">nick.jeffries@duke.edu.</a>
What is Involved?
If you choose to join this study, you will be randomly assigned (like a coin flip) to 1 of 2 groups:</ul>
<li>Group 1 will get treatment with surgery alone</li>
<li>Group 2 will get treatment with chemotherapy before surgery</li></ul>
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.
<li>Group 1 will get treatment with surgery alone</li>
<li>Group 2 will get treatment with chemotherapy before surgery</li></ul>
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)
(STRASS 2)
Principal Investigator
Richard
Riedel
Protocol Number
PRO00113761
NCT ID
NCT04031677
Phase
III
Enrollment Status
Open to Enrollment