More than half of soft tissue sarcoma (STS) patients are diagnosed older than 60 years and prognosis for advanced disease is unfavourable with a median overall survival (OS) of ∼12 months remaining substantially unchanged during the last 20 years. Quality of Life (QoL), especially when collected directly from the patients as Patient Reported Outcome (PRO) measures, has gained increasing interest in cancer care; however, existing data among elderly STS patients are scarce. The rationale of the E-TRAB study is to analyze QoL and PRO data in the elderly population (aged ≥ 60 years) with advanced STS, considered to be unsuited to receive anthracycline-based chemotherapy, and treated with trabectedin as a 1st line therapy.
The E-TRAB (GISG-13) study is designed as a non-interventional trial (n = 110). Primary endpoints to be evaluated are OS and QoL. It is hypothesized that OS will not be
Clinical trial identification
Legal entity responsible for the study
This investigator-initiated (IIT) study was sponsored by GWT-TUD GmbH, Dresden, Germany, with support from PharmaMar, S.A., Madrid, Spain.
B. Kasper: Honoraria and research funding by PharmaMar. P. Reichardt, M. Schuler, P. Hohenberger: Honoraria and research funding from PharmaMar.