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NCT00069121 · OUTCOME

Overall Survival [Number of Events]

A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer · Source last updated 2020-03-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months).

What was measured

Overall survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Participants 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.

Analysis population: Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized.

Groups in this outcome

5-FU/LV

Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m\^2 IV bolus injection + 5-FU 425 mg/m\^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m\^2 by two-hour IV infusion + 5-FU 500 mg/m\^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)

XELOX

Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m\^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
5-FU/LV942
XELOX944

Reported measurements

Patients With Event
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
5-FU/LV286Not reportedNot reportedNot reportedNot reported
XELOX242Not reportedNot reportedNot reportedNot reported
Patients Without Events
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
5-FU/LV656Not reportedNot reportedNot reportedNot reported
XELOX702Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        286
      2. group Id
        OG001
        value
        242
    title
    Patients With Event
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        656
      2. group Id
        OG001
        value
        702
    title
    Patients Without Events
denoms
  1. counts
    1. group Id
      OG000
      value
      942
    2. group Id
      OG001
      value
      944
    units
    Participants
description
Overall survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Participants 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.
groups
  1. description
    Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m\^2 IV bolus injection + 5-FU 425 mg/m\^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m\^2 by two-hour IV infusion + 5-FU 500 mg/m\^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
    id
    OG000
    title
    5-FU/LV
  2. description
    Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m\^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
    id
    OG001
    title
    XELOX
param Type
COUNT_OF_PARTICIPANTS
population Description
Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized.
reporting Status
POSTED
time Frame
Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months).
title
Overall Survival [Number of Events]
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice