Soft tissue sarcoma is rare and heterogeneous, and accounts for just around one percent of all cancers. Though rare, it is potentially life threatening, and few patients with metastatic disease realize long term survival. For dedifferentiated liposarcoma, the median survival was recently reported as only 13.9 months. So the question is raised, can treatment for dedifferentiated liposarcoma be improved?
EORTC trial 1202 is a randomized phase II trial designed to determine whether cabazitaxel or prolonged infusional ifosfamide demonstrate sufficient anti-tumor activity in patients with metastatic or inoperable locally advanced dedifferentiated liposarcoma. The primary endpoint of this study is progression-free survival as assessed at twelve weeks following randomization.
Dr. Larry Hayward, of the Western General Hospital in Edinburgh and Coordinator of this study, points out, “We chose a parallel phase II design to ease the financial and temporal costs of this trial. It is not a direct comparison of the two treatment arms, each agent will be evaluated independently. We included central pathology review as part of this trial’s protocol, and molecular analyses will check for the presence of characteristic molecular targets. So, if a patient’s disease progresses on treatment, we will already have had their tissues analyzed, and the patient could be readily recruited to targeted therapy studies as soon as those become available.”
Based on the number of responses observed, either 17 or 37 eligible and treated patients will be required in each treatment arm separately according to a Simon two stage design. As patients will only be evaluable for the primary end-point 12 weeks after the start of therapy, accrual will be temporarily stopped after 19 patients have enrolled in each treatment arm (allowing for 10% of untreated or ineligible patients). Up to 50 patients per arm could be registered to account for potential loss to follow-up and screening failure at central review. Enrolled patients will be stratified by institution, performance status (0 versus 1), and prior therapy (ifosamide versus molecularly targeted versus other).
The phase II randomized EORTC 1202 trial will be conducted in about 20 institutions located in six countries: Belgium, France, Germany, Italy, the Netherlands and the United Kingdom. It is supported by an educational grant from Sanofi Aventis and led and supported by the EORTC Soft Tissue and Bone Sarcoma Group.
For more information concerning EORTC trial 1202: www.eortc.org/contact
John Bean, PhD
EORTC, Medical Science Writer