XELOX vs FLOT in perioperative treatment of gastric cancer: randomized clinical trial in real world settings (study protocol, PECORINO trial)

Background: Gastric cancer remains one of the leading causes of cancer-related morbidity and mortality. It requires combination of chemotherapy and surgery to achieve the longest overall survival and disease-free survival. However, chemotherapy regimens have a significant toxicity level that prevents patients from completing the entire treatment protocol. Methods This is a prospective randomized clinical trial aiming to assess an intolerance of chemotherapy related adverse effects in patients with resectable gastric cancer receiving perioperative XELOX and FLOT regimen. The primary endpoint is a quantity of patients who complete all the protocol treatment without any deviations. Secondary endpoints are pathological regression rate, chemotherapy toxicity profile, disease-free survival rate and overall survival rate. Results The results of the trial will demonstrate the proportion of patients who are able to complete protocol treatment without any deviations in real world settings and its impact on overall survival and disease-free survival rates. Conclusion The protocol compliance is one the main factors in successful treatment of gastric cancer. In case the compliance of chemotherapy regimen with potentially lower toxicity has bigger impact than application of three-drug scheme, it can play a significant role in real-world settings.