Retroperitoneal sarcoma is a very rare tumour, occurring in 0.5 to 1.0 per 100,000 of the population. Diagnosis and treatment are challenging. The standard of care consists currently of surgery. Overall patient survival at 5 years following surgery is between 60 and 70%.
The EORTC 1809 STRASS 2 study is the first official trial looking into potential benefits of chemotherapy before surgery to improve disease control and survival in patients burdened by this rare cancer. June 2023 signals the start of a new observational arm called STREXIT 2, attached to the ongoing clinical trial in order to capture real world data from patients who are not eligible to participate in STRASS 2.
The aim is to compare the clinical outcomes between STRASS 2 and STREXIT 2 and to explore the possible combination of STRASS 2 and matched STREXIT 2 patients. This will strengthen the results obtained from the randomised clinical trial data and increase the power of subgroup analyses.
The early incorporation of real-world data (STREXIT 2) into the trial (STRASS 2) will enrich the study population and provide a pragmatic approach to addressing crucial causal questions within a rare cancer population.