This study will compare the efficacy and safety of intermittent oral Xeloda plus Eloxatin with that of fluorouracil/leucovorin in patients who have had surgery for colon cancer and no previous chemotherapy. The anticipated time on study treatment is until disease progression and the target sample size is 500+ individuals.

Official Title

A Randomized, Open-Label Study of the Effect of Intermittent Xeloda in Combination With Eloxatin, Versus Fluorouracil/Leucovorin, on Disease-Free Survival in Patients Who Have Undergone Surgery for Colon Cancer.


Colorectal Cancer

Study Type


Study Design

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Details

  • Primary Outcome Measures: Efficacy: Superiority in disease-free survival
  • Secondary Outcome Measures: Efficacy: Overall survival Safety: Adverse events, laboratory tests

Study Start

April 2003

Eligibility & Criteria

  • Ages Eligible for Study: 18 Years and above
  • Genders Eligible for Study: Both

Inclusion Criteria:

  • adult patients >=18 years of age
  • colon cancer
  • complete tumor resection.

Exclusion Criteria:

  • prior treatment with cytotoxic chemotherapy, radiotherapy, or immunotherapy for the currently treated colon cancer.

Total Enrolment


Contact Details

  • For more information, contact Roche Pharmaceuticals

Australian Trial Locations:

  • MELBOURNE, 3128
  • SYDNEY, 2050
  • PERTH, 6008
  • ADELAIDE, 5011
  • MELBOURNE, 3011
  • WOLLONGONG, 2500

All content and media on the HealthEngine Blog is created and published online for informational purposes only. It is not intended to be a substitute for professional medical advice and should not be relied on as health or personal advice. Always seek the guidance of your doctor or other qualified health professional with any questions you may have regarding your health or a medical condition. Never disregard the advice of a medical professional, or delay in seeking it because of something you have read on this Website. If you think you may have a medical emergency, call your doctor, go to the nearest hospital emergency department, or call the emergency services immediately.