Methods
Cancer
CANCER
NACATRINE is an open-label phase II randomized trial conducted in a single center in Brazil. The study was conducted in compliance with the guidelines of the Declaration of Helsinki, International Conference on Harmonization and Good Clinical Practice. All patients gave informed consent for using tissue and biomarker evaluation for research purposes. The NACATRINE trial was approved by the Medical Ethics Committee of Barretos Cancer Hospital (1.796.766) and was registered at ClinicalTrials.gov under the number NCT02978495. All patients signed voluntary informed consent before study entry.