Composition of the coordinating center and trial steering committee
Vilnius University hospital Santaros Klinikos is the coordinating center of the study, and it will coordinate the trial and trial sites. Bi-monthly meetings led by the principal investigator are held to provide routine organizational support.A trial steering committee consisting of clinicians (surgeon, medical oncologist), statistician, data manager, and research assistant are established to monitor and supervise the progress of the study. Study monitors will have full access to the data. The monitoring plan includes verification of the informed consent form, checking if patients meet inclusion and exclusion criteria, and monitoring the quality of the data recorded in the case report form. It is planned to review data of the 25% of included patients. Additionally, the steering committee will review relevant information on the topic of the research from other related studies in bi-annual meetings.