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CONKO-003 trial

Phase III trial

Progression

during first-line

gemcitabine monotherapy

were eligible

Study conducted at 16 sites throughout Germany

N 160

patients advanced disease (88% M1)

FF

comprised intravenous (IV) folinic acid 200 mg/m

2

followed by a continuous IV

infusion of fluorouracil 2,000 mg/m

2

over 24 hours on days 1, 8, 15, and 22.

OFF

comprised FF and oxaliplatin 85 mg/m

2

IV administered before FF on days 8 and

22

Recruitment period from January 2004 until May 2007 (> 3 y)

Post-progression treatment 25%

(OFF 22, FF 18).

Oettle et al. JCO 2014;32:2423-9