An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") Versus Bolus and Continuous Infusion Fluorouracil/ Intravenous Leucovorin With Intravenous Oxaliplatin (Q2W) ("FOLFOX4") as Treatment for Patients With Metastatic Colorectal Cancer Who Have Received Prior Treatment With CPT-11 in Combination With 5-FU/LV as First Line Therapy

Trial Profile

An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") Versus Bolus and Continuous Infusion Fluorouracil/ Intravenous Leucovorin With Intravenous Oxaliplatin (Q2W) ("FOLFOX4") as Treatment for Patients With Metastatic Colorectal Cancer Who Have Received Prior Treatment With CPT-11 in Combination With 5-FU/LV as First Line Therapy

Completed
Phase of Trial: Phase III

Latest Information Update: 03 Apr 2016

At a glance

  • Drugs Capecitabine (Primary) ; Fluorouracil; Folinic acid; Oxaliplatin
  • Indications Colorectal cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Roche
  • Most Recent Events

    • 07 Jun 2011 Pooled analysis results presented at the 47th Annual Meeting of the American Society of Clinical Oncology.
    • 24 Sep 2009 Data were submitted to the Japanese Ministry of Health, Labour and Welfare (MHLW) in February 2008, and approval for the use of capecitabine in patients with advanced/refractory colorectal cancer was granted on 18 Sept. 2009.
    • 27 Sep 2007 Results presented at ECC 2007.
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