Treatment intolerance related to perioperative chemotherapy in patients with gastric cancer, prospective randomized clinical trial

Dobrzhanskyi O., Kondratskyi Y., Razumeiko I., Suprunenko O., Shudrak A., Kolesnik A., Pepenin M., Shudrak E.

Summary. Introduction. Gastric cancer still shows high rates of morbidity and mortality among different sites of oncological neoplasms. Talking about Ukrainian population there are no any randomized clinical trials which aimed to assess efficacy and safety of different treatment modalities. Methods. We have been conducting a prospective randomized clinical trial on assessment of intolerance of chemotherapy-related adverse effects in patients with resectable gastric cancer receiving perioperative XELOX and FLOT regimen. The primary endpoint is protocol compliance. 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 and its impact on overall survival and disease-free survival rates among Ukrainians. Conclusion. Completing treatment protocol without any deviation may play a pivotal role in treatment of gastric cancer. In case the compliance of chemotherapy regimen with potentially lower toxicity has bigger impact than usage of three-drug combination it may change an approach in treatment of such cohort of patients. Primary registry and trial identifying number: NCT03009227. Date of registration in the primary registry: 24.06.2021.

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