A randomized phase III study of neoadjuvant chemotherapy followed by surgery versus surgery alone for patients with High-Risk RetroPeritoneal Sarcoma (STRASS 2)

Clinical Study: 

• Randomized: The study is divided into two different groups, each receiving a different treatment. The treatment each group receives is determined using a computer program. This procedure is similar to flipping a coin and is called randomization. It ensures that the patient groups are similar at the start of the study. The two groups are: one group will receive only surgery, and the other group will receive preoperative chemotherapy followed by surgery. 
• Multicenter: Several hospitals and treatment centers in Italy and/or abroad are involved in the study. 
• Open-label: Both the investigator and the clinical trial participant know the outcome of the randomization, meaning they are aware of the treatment selected. 

The aim of this study is to determine whether the administration of chemotherapy before surgery is a more effective treatment than surgery alone, and if the administration of chemotherapy before surgery is safe for patients with high-risk Dedifferentiated Liposarcoma (DDLPS) and Leiomyosarcoma (LMS). For DDLPS, the preoperative treatment will involve the combination of Doxorubicin-Ifosfamide, while for LMS, the combination of Doxorubicin-Dacarbazine will be used. Both of these drug combinations bind to the DNA of cancer cells, blocking their growth. 

The study also includes another subgroup/cohort of patients, called the observational cohort (i.e., a group of patients who are only observed over time without any external interventions), which will serve as a comparison to the cohort receiving treatment.