Can we improve treatment for patients with advanced dedifferentiated liposarcomas?
20 Aug 2014
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
Related News
EORTC: Advancing research and treatment for rare cancers
29 Feb 2024
EORTC Fellowship Programme: celebrating more than 20 years of impactful collaboration
22 Feb 2024
Appointment of Malte Peters as EORTC Strategic Alliance Officer
9 Feb 2024
Unique series of workshops in partnership with the European Medicines Agency (EMA)
7 Feb 2024
EORTC launches a prominent clinical trial in older patients with locally advanced (LA) HNSCC (Head and Neck Squamous Cell Carcinoma)
14 Dec 2023
Seven IMMUcan abstracts selected for ESMO Immuno-Oncology Congress 2023
6 Dec 2023
EORTC Quality of Life measures integrated in CDISC
20 Nov 2023
EORTC and Immunocore are collaborating to launch the ATOM clinical trial of tebentafusp in Adjuvant Uveal Melanoma
7 Nov 2023
Treatment with decitabine resulted in a similar survival and fewer adverse events compared with conventional chemotherapy in older fit patients with acute myeloid leukaemia
31 Oct 2023
New results and forthcoming EORTC trials in rare cancers, lung, head and neck, and breast carcinomas presented at ESMO 2023
20 Oct 2023