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Background:

Only a few clinical trials have been conducted in patients with advanced pancreatic cancer after failure of first-line gemcitabine-based chemotherapy. Therefore, there is no current consensus on the treatment of these patients. We conducted a randomised phase II study of the modified FOLFIRI. 3 (mFOLFIRI. 3; a regimen combining 5-fluorouracil (5-FU), folinic acid, and irinotecan) and modified FOLFOX (mFOLFOX; a regimen combining folinic acid, 5-FU, and oxaliplatin) regimens as second-line treatments in patients with gemcitabine-refractory pancreatic cancer.

Methods:

The primary end point was the 6-month overall survival rate. The mFOlFIRI. 3 regimen consisted of irinotecan (70 mg m− 2; days 1 and 3), leucovorin (400 mg m− 2; day 1), and 5-FU (2000 mg m− 2; days 1 and 2) every 2 weeks. The mFOLFOX regimen was composed of oxaliplatin (85 mg m− 2; day 1), leucovorin (400 mg m− 2; day 1 …