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

• Disease-free Survival (DFS) [Number of Events] [ Time Frame: Time from randomization date to date of first event/date last known to be event free. Median observation time for DFS was approx 57 mos. ] [ Designated as safety issue: No ]
  Number of patients with/without recurrence of the original colon cancer or appearance of a new colon or rectal cancer, or death due to any cause. Based on tumor assessments and survival follow-up assessments.
• Disease-free Survival [Time to Event] [ Time Frame: Time from randomization date to date of first event/date last known to be event free. Median observation time for DFS was approx 57 mos. ] [ Designated as safety issue: No ]
  Determination of an event was based on tumor assessments and survival follow-up assessments. Any recurrence of the original colon cancer or appearance of a new colon or rectal cancer was to be proven by cytology or histology, when possible. An isolated event of increased CEA, or unexplained clinical deterioration were not considered to be evidence of relapse without support of other objective measurements. The date of relapse was defined as the date of the definitive assessment by objective measurements.

• Relapse-free Survival (RFS) [Number of Events] [ Time Frame: Time from randomization date to date of first event/date last known to be event free. Median observation time for RFS was approx 57 mos. ] [ Designated as safety issue: No ]
  Included only recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer.
• Relapse-free Survival (RFS) [Time to Event] [ Time Frame: Time from randomization date to date of first event/date last known to be event free. Median observation time for RFS was approx 57 mos. ] [ Designated as safety issue: No ]
  Included only recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer. Patients who were not reported as having died at the time of the analysis were censored using the date they were last known to be relapse free.
• Overall Survival [Number of Events] [ Time Frame: Time from randomization date to date of death/date last known to be alive. Median observation time for was approx 59 mos. ] [ Designated as safety issue: No ]
  Survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Patients who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.
• Overall Survival [Time to Event] [ Time Frame: Time from randomization date to date of death/date last known to be alive. Median observation time for was approx 59 mos. ] [ Designated as safety issue: No ]
  Survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Patients who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.
• Number of Participants Assesed for Adverse Events [ Time Frame: followed from Time of Very First Drug Intake and 28 day(s) after Very Last Drug Intake ] [ Designated as safety issue: No ]

  Adverse events were presented in individual listings and summarized by Medical Dictionary for Regulatory Activities (MedDRA)System Organ Classes, intensity, and relation to trial treatment. Laboratory data are summarized in two ways: Summary of laboratory abnormalities (regardless of the baseline values), with particular attention to the more clinically relevant Grade 3/4 laboratory abnormalities. Summary of laboratory abnormalities as a shift from baseline.

  See Adverse Events module for details.

This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery for colon cancer and no previous chemotherapy. Patients will be randomized to receive either 1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2)5-fluorouracil + leucovorin in 4 or 8 week cycles. The anticipated time on study treatment is until disease progression and the target sample size is 500+ individuals.

• Drug: capecitabine [Xeloda]
  1000mg/m2 iv bid on days 1-15 of each 3 week cycle
• Drug: Oxaliplatin
  As prescribed, in 3 week cycles
• Drug: Oxaliplatin
  As prescribed, in 2 week cycles
• Drug: Leucovorin
  As prescribed, in 2 week cycles.
• Drug: 5 FU
  As prescribed, in 2 week cycles

• Experimental: 1
  Interventions:

  • Drug: capecitabine [Xeloda]
  • Drug: Oxaliplatin
• Active Comparator: 2
  Interventions:

  • Drug: Oxaliplatin
  • Drug: Leucovorin
  • Drug: 5 FU

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.