Phase III trial of infusional 5-fluorouracil/folinic acid plus oxaliplatin (FUFOX) versus capecitabine plus oxaliplatin (CAPOX) as first line treatment of advanced colorectal carc…
HT Arkenau, HJ Schmoll, S Kubicka, T Seufferlein, P Reichardt, W Freier, U Graeven, A Grothey, R Porschen · Zeitschrift für Gastroenterologie · 2004 · Heft 08
Bibliografische Angaben
Zusammenfassung
Aims: In a previous phase III study the FUFOX regimen has shown superior response rates than bolus 5-FU/FA (Mayo Clinic protocol) in patients with. The combination of capecitabine (CAP) and oxaliplatin (OX) has demonstrated good efficacy and safety results in recent phase II studies. In August 2002 we initiated a phase III trial to compare FUFOX and CAPOX as first line therapy in patients with ACRC. Here, we present the results of the planned interim safety analysis. Patients and methods: From 08/2002 to 10/2003 275 patients of the target number of 420 (m: f=176: 99; median age 66 (range 32–85)) have been random…