Source data were documented in the clinical charts at the Incancer using specially designed templates to ensure the completeness of data documentation for patient eligibility and clinical visits. Other source documents like signed informed consent forms, radiology and pathology reports were included in the patient files. Anonymised data were entered on electronic Case Report Forms (eCRFs) using a Good Clinical Practice (GCP), 21 CFR Part 11 compliant platform OpenClinica©. The eCRFs were designed by the study researchers and organised into clinical events, each with a single repetition (e.g. baseline, diagnosis, surgery). The use of eCRFs prevents data entry errors, allows one to easily keep track of form changes, helps solve data entry discrepancies and improves overall clinical team coordination. After data entry and review, reports were extracted from OpenClinica© as spreadsheets, and Matlab [15] was used to automatically compute descriptive statistics. Descriptive statistics were used for demographics baseline characteristics, TNM and toxicity evaluation.

Kaplan–Meier curves for overall survival were generated. To assess statistical differences between variables, the log-rank test was used (p-value < 0.05). For univariate survival analysis, the Cox proportional hazards model was applied. Statistical analysis was performed using Stata v15.0.

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