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Sequential methotrexate, 5‐fluorouracil (5‐FU), and high dose leucovorin versus 5‐FU and high dose leucovorin versus 5‐FU alone for advanced colorectal cancer. A multi‐institutional randomized trial

Background. The primary objective of this study was to compare the single‐biochemical modulation of 5‐fluo‐rouracil (5‐FU) and leucovorin with that of the double‐biochemical modulation of methotrexate and leucovorin. Because of the Martin et al. study in which an experimental model showed similar effects of 5‐FU at maximum tolerated doses to the modulation with leucovorin at standard doses, a third treatment arm of 5‐FU alone was also studied.