A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer

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.

Conditions

Colorectal Cancer

Study Type

Interventional

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

500

Contact Details

• For more information, contact Roche Pharmaceuticals

Australian Trial Locations:

• MELBOURNE, 3128
• SYDNEY, 2050
• PORT MACQUARIE, 2444
• PERTH, 6008
• ADELAIDE, 5011
• MELBOURNE, 3011
• WOLLONGONG, 2500